Donor

Handbook

Japan Marrow Donor Program

Public Interest Incorporated Foundation Japan Marrow Donor Program

Introduction
This time, you have been chosen
as potential marrow or apheresis donor for a patient.
However, potential marrow orapheresis donor do not have to donatebone marrow or peripheral blood stem cells
against their wishes.
This handbook will provide you withall the necessary information about donation.
Above all, your health and safety is
the topmost priority of theJapan Marrow Donor Program.

3

Handling of Personal Information

About this Handbook

The Japan Marrow Donor Program (a public interest incorporated foundation; theIn this handbook,

JMDP ) recognizes the protection of information on individuals ( personal information )the person donating bone marrow oras an important responsibility. We have established a privacy policy, thoroughly notiﬁed
all staﬀ and stakeholders of this, and will strive to protect your personal information.
Any personal information (name, address, past medical history etc.) provided by
the donor to the JMDP, as well as results of the tests carried out during thecoordination process, will be strictly managed in compliance with the Act on theProtection of Personal Information .

peripheral blood stem cells is the potential donor ,and the person undergoing transplantation is the patient .
Also, once you become a potential donor,
the entire process of provision of bone marrow or
peripheral blood stem cells,

The potential marrow or apheresis donor s personal information is used between

right up to the coordination of the completion

the JMDP and personnel deemed necessary by the JMDP in coordinating theof the follow-up is the coordination process .

process between the patient and the donor, namely, the coordinator, physician
for conﬁrmatory typing (CT), Collection Center (CC) / Apheresis Center (AC),and Transplant Center (TC).
In addition, this information (without your personal information such as nameand address etc.) will be used by institutions, or designated data management
institutions and authorized personnel approved by the JMDP, as well as
approved researchers, to create statistical data and for research purposes.
Please visit the following website for more details on our privacy policy.
• You

do not agree

to your data being used beyond the coordination process

for research to improve the transplant performance or the safety of donors(while your data will be automatically included in the epidemiology study, it will
not be used for research if you indicate otherwise).
• You informed us, or have any questions about the correction or changes inyour personal information during the coordination process (we will provide theThis handbook describes the ﬂow of the coordination
process and information that you would need tounderstand in becoming a potential donor.
The ﬂow of the coordination process issummarized on pages 6 to 9.
We would like you to have a rough understandingof the information here,
carefully read the detailed explanation
under the table of contents,
and consider whether you would like to request
for coordination help.

updated information to the Japanese Red Cross Society if you inform us of any
changes to the registered information such as name and address).
* Please bring this handbook with you during conﬁrmatory typing (CT)
Please visit the following website for more details on our privacy policy.

http://www.jmdp.or.jp/policy.html

4and for the Donor Information Session for your ﬁnal consent.

5

Flow from becoming a potential donor to donating

1 Notiﬁcation as a potential donor.
hapter 1. I. What is the JMDP? (page 12)

We will notify you when your HLA (a type of white blood cell) matches with that ofthe patient.
Please answer the questionnaire about whether you are interested to donate andyour family s wishes, schedule, and health condition.
At the JMDP, donors are not allowed to choose patients or set terms to be fair to everyone.

2 Conﬁrmatory typing (CT)
Chapter 2. I. Conﬁrmatory typing (CT) Stage (page 20)

On the day of conﬁrmatory typing (CT), please present a document
conﬁrming your intention to donate.
The coordinator would explain to you in detail during the meeting about
the conﬁrmatory typing (CT) stage, and the physician will provide themedical explanation and interview you.
If you still wish to donate, we will collect blood from you to verify yourhealth condition etc.

3 Final consent
Chapter 2. II Final consent (page 24)

Once you are selected as a donor, the coordinator and coordinating
physician will conﬁrm with your and your family s ﬁnal intention to donate
in the presence of a witness.
You will not be able to withdraw your oﬀer to donate after you have given
your ﬁnal consent.
If the donor withdraws his/her oﬀer to donate due to strong opposition from the family,
the patient may not be able to receive the appropriate treatment.
Your family s consent is therefore necessary so that such situations will not happen.

4 Medical examination
Chapter 2. III Once harvest is decided (page 26)

About one month before you donate bone marrow or peripheral blood stem
cells, you will undergo a detailed medical examination conducted by aphysician at the CC/AC (a JMDP-accredited hospital) to prepare for asafe harvest.

6

bone marrow or peripheral blood stem cells

If you are donating bone marrow

If you are donating peripheral blood stem cells

Chapter 3. A. Bone marrow harvest (page 31)

Chapter 3. B. Peripheral blood stem cells harvest (page 36)

5 Collecting blood for autologous

5 IInjecting a drug (G-CSF) to increase

blood transfusion

To reduce the possibility ofanemia after the harvest, we willcollect your blood in advance (1to 3 weeks before day of harvest)
when necessary.

6 Bone marrow harvest
You will be usually hospitalized
for about 4 days 3 nights.
You will be hospitalized 1 to 2
days before the day of harvest,
undergo health checks, andphysicians will explain the process
to you.

your white blood cell countWhen you are injected with G-CSF over a
period of 3 to 4 days (hospital visit or
hospitalization), hematopoietic stem cells
will be stimulated into the peripheral blood.

6 Peripheral blood stem cells harvest
TThe peripheral blood stem cells will be harvested
on either day 4 or day 5 after G-CSF injection.
If not enough cells are harvested, we will repeat
the procedure again on the following day.
Ifyoureceivetheinjection

duringyourhospitalization, you will be hospitalized for about
5 days 4 nights to 7 days 6 nights. If you receive the injection during
your hospital visits over a period of 2 to 4 days, you will be hospitalized
for about 2 days 1 night to 4 days 3 nights.

7 Bone marrow/peripheral blood stem cells to patients
Chapter 1. II What is hematopoietic stem cell transplantation? (page 14)

The harvested bone marrow/peripheral blood stem cells are transported to the patient s
hospital for transplantation.
The harvested bone marrow/peripheral blood stem cells are transported to the patient s hospital ,transplant center (TC).

8 Hospital discharge within a few days after harvest*Depends on method of harvest.

You will be discharged from the hospital a few days after the harvest. The coordinator
will regularly check with you on your health condition via phone, and you will be asked
to go for a medical examination 1 to 4 weeks after the harvest. The coordinator will
follow-up with you until you make a full recovery.

◎Medical expenses for the harvest of bone marrow/peripheral blood stem cells will be fully paid by the patient s healthinsurance. (See Chapter 5, I. Cost Burden of Donors on page 51)◎While we have prioritized the safety of donors, there have been unfortunate instances where some donors have suﬀered healthinjuries. In such cases, we will make insurance payout from an accident insurance which the JMDP has enrolled donors in.
(See Chapter 5, II. JMDP Group Accident Insurance for Donor Compensation on page 52)◎We may not make the insurance payout depending on circumstances such as the donor s health condition or the patient s situation.
(See Chapter 2, IV. Termination and Temporary Suspension of Coordination Process on page 29)7Schedule after conﬁrmatory typing (CT)Day 0

Conﬁrmatory typing (CT) (about 1 to 2 hours)

About 2 weeks

Screening test result notiﬁcation

1 to 2 months later

Donor selection notiﬁcation

1 to 3 months later

Final consent (1 to 2 hours)* For coordination on donating bone marrow or
peripheral blood stem cells, the method of
donation will be decided by the JMDP.

Performed up to 21 daysin advance

weekdays.

7 to 21 days before

1 to 2 days before

Day 0

If you are donating
peripheral blood stem cells(1 to 2 hours)*0 to 2 times

Hospitalization

Bone marrow harvest(2 to 3 hours)

Q Can I visit go at a speciﬁc date/time or at my own convenience?
Performed up to 21 daysin advance

Medical examination (2 to 3 hours)
Autologous blood collection

Injection of granulocytecolony-stimulating factor (G-CSF)(About 1 hour)*Over a period of 3 to 4 days

Hospitalization■Day 4 or Day 5•Inject G-CSF•Peripheral blood stem cells harvest

Discharge

After 1 week

Checking up with you via phone

After 2 to 3 weeks

Medical examination after harvest(5 to 10 minutes)

3 to 4 days before

If you are not able to visit the medical institution during a certain
period, please ﬁll out the reply form and inform to the coordinator/

From the ﬁrst day of G-CSF injection

JMDP Donor Center.

to the day of harvest

Day 0(3 to 4 hours)■Day 5 or Day 6*If suﬃcient cells(Afterare harvested•Inject G-CSF•Peripheral blood stem cells harvest 1 day)
(3 to 4 hours)

Discharge

A We will take into account the donor s convenience and adjust theschedule, but there are times when we are unable to do so.

*If suﬃcient cells are not harvested

After 2 to 3 days

Q How often and when do I have to go to the medical institution ?
A About 8 times. Please visit a medical institution during the day on

Decision on harvest schedule and facility(CC/AC)

If you are donating bone marrow

Stage

Q About when do I have to be hospitalized (harvest)?
A It will take about 2 to 4 months, from the conﬁrmatory typing (CT) to
the harvest procedure.
We will inform you of the patient s desired transplant timing if it is
known at the beginning of the coordination process, but we may informyou again when you are selected as the ﬁnal donor as the transplant

After 1 to 2 days

date may change due to the patient s treatment progress etc.

Checking up with you via phone(1 to 2 hours)(5 to 10 minutes)

Medical examination after harvest(1 to 2 hours)

After 3 months

Questionnaire

After 1 year

Conﬁrmation of registration intention

Questionnaire

Once a week, up to 4 weeks

After 1 to 4 weeks

After 3 months

Conﬁrmation of registration intention,questionnaire

After 1 year

Questionnaire

After 2 to 5 years

Please let us know as soon as possible if you have any health issues orif the schedule is inconvenient for you.

Please see the schedule and required time as a rough guideline as it will diﬀer for diﬀerent people.

89

Table of Contents
The chapters you need to read will vary dependingon the contents of the guide.

Chapter 1

JMDP s Coordination Process

We will guide you on the process depending on the needs of the patient or thesituation of the potential donor. Please refer to the Notice of Coordination Process(Compatibility notice) that we are sending with this booklet.

① Information on coordination process for bone marrow donation

Basic Understanding

I. What is the JMDP?

P.12

II. What is hematopoietic stem cell transplantation?

P.14

III. Conditions to become a donor

P.17

Chapter 2
The JMDP coordinates bone marrow transplantation and peripheral blood stem cells
transplantation.
The transplantation method to the patients is the same, but the method of donation
is diﬀerent.

Coordination process Coordination process
for bone marrowfor peripheral blood
donorsstem cells donors

P.20

II. Final consent

P.24

III. Once harvest is decided

P.26

Chapter 3○○○

About the Harvest Procedure

A. Bone marrow harvest
I. Schedule of bone marrow harvest

P.31

II. From preparation for bone marrow harvest to the follow-up
after harvest

P.32

III. Risks and discomforts of bone marrow harvest (anesthesia)

P.35

○

○

B. Peripheral blood stem cells harvest
P.36

II. From preparation for peripheral blood stem cells harvest to
the follow-up after harvest

P.37③ Information on coordination process for bone marrow or
peripheral blood stem cells donation

III. Risks and discomforts of the apheresis procedure

P.41

As the potential donor may be asked to donate either bone marrow or peripheral
blood stem cells for ③ , please kindly read both chapters.

○

IV. Termination and Temporary Suspension of Coordination Process P.29

I. Schedule of peripheral blood stem cells harvest

Since the medical treatment on donors is diﬀerent for ① and ② , please read therespective sections in Chapter 3 and Chapter 6.

○

How the Coordination Process Works

I. Conﬁrmatory typing (CT) Stage② Information on coordination process for peripheral blood stem
cells donation(We will check with the intentions of the potential donor and the patient, and decide on one donation
method when the ﬁnal a potential donor is selected)○

Coordination process
for bone marrowor peripheral blood
stem cells donors

Chapter 4○○

Other Matters

I. Diﬀerence between bone marrow transplantation and peripheral
blood stem cells transplantation

P.44

II. Freezing of bone marrow and peripheral blood stem cells

P.46

○

III. Donor registration after bone marrow and peripheral blood stem cells harvest P.47
IV. Protecting the privacy of donor and patient

P.48

V. DLI (Donor Lymphocyte Infusion)

P.49

VI. Storing your samples

P.49

○

○

○

○

○

○

○

○
○

VII.Disclosure of information when genetic information etc. of donor is obtained
P.50
from the donation of bone marrow or peripheral blood stem cells

Chapter 5

I. Cost burden of donors

P.51

II. The JMDP Group Accident Insurance for donor compensation

P.52

Chapter 6

10Fees and Compensation

Reference Documents

I. Bone marrow donation

P.55

II. Peripheral blood stem cells donation

P.67

○

11

Roles of coordinator and the physician for CT

The coordinator coordinates with the donors, physicians for CT, CC/AC, and the DC.
They will also accompany you for the preparation and explanation of the conﬁrmatory
typing (CT) and ﬁnal consent interview, medical examination at CC/AC, and during
your hospitalization and discharge.

◎ The JMDP is a public enterprise that acts as an intermediary betweenbone marrow transplantation and peripheral blood stem cells
transplantation between unrelated individuals.
◎ Once the coordination process begins, JMDP Donor Center(DC) of theresidential area of the donor will take charge, and the coordinator andphysician for conﬁrmatory typing (CT) will be decided for each donor.

questions, determining the eligibility of donors and blood collection.

Donor
Collection Center (CC) /Apheresis Center (AC)Physician responsible
for harvest

How the coordination process works

send you a Notice of Coordination Process (Compatibility notice) and a reply form. Once
we receive your reply form, the coordination process conducted by DC (7 districts
nationwide) will begin. The coordinators and coordinating physicians belong to DC, and thecoordinator and physician for CT responsible for the donor is then decided.

Physicianfor CT

Donor Center(DC) staﬀ

Once you are selected as a donor candidate ( donor ), the initial coordinator in-charge will3

Corporation
Hospitalfor CT

Whatisisthe
theJMDP?
JMDP?
Ⅰ What1

The physician for CT is responsible for medical explanation and answering the donor s

Coordinator

Donor Center (DC)Contact method

Please contact DC by phone (weekdays daytime) or fax.
The coordinator will contact the donor via a dedicated line for coordination purposes.

■System diagram of the coordination process
If you wish to donatebone marrow or peripheral
blood stem cells

Donor

Citizens

Please contact the DC or the coordinator if you have any questions or
Leukemia &aplastic anemiaetc.

requests.

Patients

Please let us know as soon as possible if you have any health issues or if theschedule is inconvenient for you. Please also let us know if you become a lay
judge candidate.

Coordinating
activities

Corporation Hospitalfor Conﬁrmatory
typing (CT)

Publicawareness

Coordinating
activities

Testing &hospitalization

Collection Center (CC) /Apheresis Center (AC)Japanese
Red Cross Society(Some public health centers)

HarvestrequestreportDonor searchrequestJMDP Donor Center (DC)First Contacting Section

JMDP (public interest
foundation corporation)

Patient
registration

Hospitalization& discharge

HLA testing & registration

Tests

Transplant
Center (TC)National/local governments

12

13

1

章

2

Basic Understanding

Ⅰ. What is the JMDP?

第Chapter 1

Chapter 1. Basic Understanding

1
Chapter 1.

◎ Hematopoietic stem cell transplantation is a treatment that replacesdiseased hematopoietic stem cells (cells that give rise to all blood
cells) with healthy ones.

3

Hematopoietic stem cell transplantation method

Basic Understanding

Ⅱ.What is hematopoietic stem celltransplantation?

For patients, it takes 1 to 2 weeks before the transplant procedure to administer large amountsof cancer drugs or radiation to the whole body. This is called pre-transplantation treatment, andwill destroy normal hematopoietic stem cells as well as diseased cells. As the white blood cellcount will also decrease signiﬁcantly, the immune system in patients is lowered and they become
susceptible to infections. For this reason, the patient stays in a dust- and bacteria-free aseptic
room with clean air exchange during the pre-transplantation treatment process and after
transplantation until the patient s body start to produce a stable supply of normal blood cells.
On the day of transplantation, hematopoietic stem cells provided by donors that are harvested by

What are hematopoietic stem cells?

Ⅱ What is thehematopoietic
stem cell transplantation?
Ⅰ
JMDP?

1

bone marrow harvest or peripheral blood stem cell harvest, will be injected into the patient s vein.

「Hematopoietic stem cells are cells that give rise to white blood cells, red blood cells, and platelets,

Pre-transplantation
treatment
Hematopoietic stem celltransplantationand exist in the spongy hematopoietic tissue in the center of the bone called bone marrow.
The bone marrow is ﬁlled with bone marrow ﬂuid, where red blood cells, white blood cells,
and platelets are constantly generated. On the other hand, hematopoietic stem cells areusually absent in the peripheral blood (blood ﬂowing throughout the body), but when you

Hematopoietic
function ofpatients

Hematopoietic stem
cells of patients

Donor-derived
hematopoietic stem cells

inject a drug called G-CSF (granulocyte colony-stimulating factor) that increases whiteblood cells, hematopoietic stem cells will also increase in the peripheral blood; we call this

■ Bone marrow harvest method

peripheral blood stem cells.
Hematopoietic stem cells are also found in the blood of the umbilical cord and placenta.

Blood cells

Roles

When there is a shortage or abnormality

Red blood cells

Carry oxygen throughout the body

Anemia happens

White blood cells

Protect the body from pathogens

More susceptible to infectious diseases

Platelet

Stop bleedingMore susceptible to hemorrhage(Blood cell function)

2

What is hematopoietic stem cell transplantation?

When you are aﬄicted with blood diseases, your body cannot produce/make blood cells

The donor will undergo general anesthesia. A needle will be inserted into the ilium(part of pelvis), and the bone marrow ﬂuid is aspirated with a syringe (see A in Chapter
3). Also, The bone marrow is the diﬀerent from the spinal cord of nerve tissue.
Red blood cells

Bone marrow

Ilium(part of pelvis)

White blood cells

Plateletnormally, leading to illnesses such as anemia and a comprised immune system.

■ Peripheral blood stem cells harvest method

Hematopoietic stem cell transplantation is a treatment method that replaces diseased

The donor is injected with G-CSF for 3 to 4 days before harvest. When the number ofhematopoietic stem cells with those of healthy people (donors).
Transplantation of cells harvested from the bone marrow is called bone marrow transplantation,
while the transplantation of cells harvested from peripheral blood is called peripheral blood
stem cell transplantation, and those using cord blood are called cord blood transplantation.
At the JMDP, we coordinate bone marrow transplantation and peripheral blood stem cell

hematopoietic stem cells in the peripheral blood has increased, a device will be used
to separate the blood components (see B in Chapter 3).
Hematopoietic
stem cells

transplantation between unrelated individuals.
Over 300,000 cases of bone marrow transplantation and peripheral blood stem celltransplantation have already been performed worldwide.

14

15

3

Chapter 1

When to transplant and the patient s course after transplantation

Ⅲ.Conditions to become a donor

Basic Understanding

4

The timing of the transplantation to a patient is important and can be decided by observing
the course of the disease condition. Also, it is necessary to book the limited aseptic rooms
and adjust the schedule of the staﬀ at the transplant center (TC).

◎To improve the safety of donors and patients, we have set several conditions for donors.

Even after the patient undergoes transplantation, he/she may still pass away early due torejection, GVHD (graft versus host disease), and severe infections etc. Even after the◎Donors will need to be healthy, indicate their intention to donate, and obtain theconsent of their family members.

donor s hematopoietic stem cells have engrafted and the patient recovered from the◎ A donor candidate is selected when his/her HLA matches with that of the patient.

transplantation, the original disease that the patient is aﬄicted with (such as leukemia) may
also recur. The disease of all patients is not cured by hematopoietic stem cells transplant.

1

Conditions to become a donor ①

1）
You must be of age 18 to 54 when you register with us (Donor shall be between the age of 20 and 54)
The coordination process may be terminated or temporarily suspended due to the patient s condition suchas a change in the disease condition.
(See Chapter 2, IV. Termination and Temporary Suspension of Coordination Process)Even when you receive a notiﬁcation from the Japanese Red Cross Society informing you that yourregistration has been terminated when you reach the age of 55, your registration with us will still
continue if you are in the midst of the coordination process until the harvest procedure is completed.

Ⅲ Conditions to become a donor

2）Be in good health

Glossary
Engraftment ： When the transplanted hematopoietic stem cells of the donor
starts to make blood cells in the patient s bone marrow.
Rejection ： When the patient s body eliminates the transplanted hematopoietic
stem cells of the donor and left with only the patient s white blood cells.
GVHD (graft versus host disease) ： A reaction when the white blood cells in
the transplanted hematopoietic stem cells of the donor regard the tissues of thepatient s body as stranger = foreign bodies and attack the patient s cells.

Q What are the diseases that require hematopoietic stem cell transplantation?
A The main diseases include leukemia, myelodysplastic syndrome, malignant lymphoma, severe aplastic
anemia, immunodeﬁciency, and some congenital metabolic disorders.
Depending on the disease, patients may be cured with chemotherapy and immunosuppressant drugs.
But there are many patients who can only be cured with hematopoietic stem cell transplantation.

●Those who are not taking medication or undergoing treatment for illness.
● Those who do not have medical history such as malignant tumors (cancer), collagen diseases (suchasrheumatoid arthritis), myocardial infarction, angina pectoris, stroke, asthma (within 1 year of onset or
medication), convulsive disorders (such as epilepsy).
●Those whose maximum blood pressure (systolic pressure) is between 90 mmHg and 150 mmHg, andminimum blood pressure (diastolic pressure) is 100 mmHg and less.
●Those who have not received blood transfusion in the past.
●Those who will not transfer viral hepatitis, syphilis and other diseases to the patients.
● Those who do not have blood diseases and anemia (those who have already covered using
hematopoietic drugs are allowed. Those who are currently on hematopoietic drugs are not allowed).
* Please do not donate blood until the coordination process is over.
●Those who are not excessively obese; 45 kg and above for males, and 40 kg and above for females(people with BMI under 30 = weight (kg) ÷ (height (m) × height (m))* Other medical history and health condition are respectively determined through interviews or medical examinations.
Some conditions will diﬀer between bone marrow donors and peripheral blood stem cells donors.
If the donor s health condition needs to be checked, you may be asked to undergo medical
examinations and tests.
Please know that the donor will have to bear all costs.

Bone Marrow Transplantation is also known as BMT .
Peripheral Blood Stem Cell Transplantation is also known as PBSCT .

3）Those who have a suﬃcient understanding of what is involved in the donationof bone marrow and peripheral blood stem cells.
4）Those who have obtained the consent of their family members (spouse,
parents etc.) about donating bone marrow and peripheral blood stem cells.
5）Those who are not pregnant.

While this is extremely rare, it is possible to transplant the hematopoietic stem cells donated by thedonor to two siblings aﬄicted with the same disease when physicians deem that it is necessary totransplant at the same time, and certain conditions are met.

16

We will terminate the coordination process if we ﬁnd that the donor does not meet the conditions or if
the donor requests to withdraw. (See Chapter 2, IV. Termination and Temporary Suspension of
Coordination Process)17

Chapter 1

Conditions to become a donor ② (HLA compatibility)

4

Probability of compatible HLA

The donor candidate is selected when his or her HLA matches with that of the patient.

The HLA type is inherited from parents (one antigen from one parent). This leads to a

Just like diﬀerent types of red blood cells, A, B, AB, O type, there are also diﬀerent types ofcombination of 4 HA types among siblings, and one therefore has a 1 in 4 chance of being an

white blood cells.

identical match with his/her siblings.

This type is called HLA (human leukocyte antigen) or histocompatibility antigen.

In Japan, about 30% of related individuals are able to ﬁnd a person with identical, matching HLA.

The HLA has A, B, C and DR locus, each with dozens of varieties and there are tens of
thousands of combinations.

There are 4 possible HLA types for children.

Father

Diﬀerent types of HLAⒶ A24-B52-Cw12-DR15Ⓒ A2-B46-Cw1-DR8Ⓑ A33-B44-Cw14-DR13Ⓓ A11-B62-Cw4-DR4

DQ locus

DP locus

B49（21） Cw1

DR1

DQ1

DPw1

B7

B50（21） Cw2

DR103

DQ2

DPw2

A203

B702

B51（5）

Cw3

DR2

DQ3

DPw3

Ⓐ

Ⓐ

Ⓑ

Ⓑ

A3

B8

B52（5）

Cw4

DR3

DQ4

DPw4

Ⓒ

Ⓓ

Ⓒ

Ⓓ

・

・

・

・

・

・

DPw5

・

・

・

・

・

Child 2Child 3

Child 4・

DPw6Child 1

・

・

・

・

・

・

A69（28） B47

Bw4

（3）
Cw9

DR52

DQ8（3）

A74（19） B48

Bw6

Cw10
（3） DR53

DQ9（3）

B locus

A1

B5

A2

C locus

Reference：Japanese Society for Histocompatibility and Immunogenetics.

A method called DNA typing delves further into the HLA types. For example, detailed
investigation into the A2 conﬁrmatory typing(CT) revealed further subdivision of 02:01 ,02:06 , 02:07 , and 02:10 .

3

How we search for donors

After you have registered, the Japanese Red Cross Society will conduct a search across all
four locus (2 antigens per locus, 8 antigens in total) of HLA A, B, C, and DR locus using
the DNA typing method. The results are then registered in the computer system of theMother

Ⅲ Conditions to become a donor

DR locus

A locus

Basic Understanding

2

Even in transplantation between related individuals, GVHD and rejection are likely tooccur when the HLA is not an exact match. Even with transplantation from unrelated
individuals, if the HLA is an identical match, we can expect a success rate close totransplantation from related individuals.
As there are many Japanese people with similar HLA, and more than 450,000 donor
registrants have registered with us, the JMDP is able to ﬁnd people with compatible
HLA types for about 95% of Japanese patients registered with us.

Q Are there overseas patients?
A There have been cases when the HLA of Japanese donors are identical with that of patientsregistered with overseas bone marrow banks. The coordination process is basically the same
regardless of domestic or overseas. Since the date and place of evaluation and harvest may be
restricted, we will inform you at the beginning of the coordination process.

Japanese Red Cross Society, and we then search for donors whose HLA are highly
compatible with that of the patient.
If you registered before August 2009, DNA typing may not have been performed on all donors.

18

19

Chapter 2

Chapter 2. How the Coordination Process Works
3）Medical interview, medical examination, blood collection

How the Coordination Process Works

Ⅰ.Conﬁrmatory typing (CT) Stage

After the explanation, if you agree to the following ① to ④, please sign on theConsent form for conﬁrmatory typing (CT) . After this, the physician for CT will
perform simply medical examinations such as medical interview and blood pressure◎ The coordinator and physician for CT will explain to you the process indetail and check with each other that there are no problems before
proceeding on with the coordination.
◎ You will undergo a medical interview and medical examination by thephysician for CT after the interview. If there are no problems blood will
be collected from you

tests, and draw about 30 ml of blood if there are no problems (the volume of bloodcollected may diﬀer if the patient is located overseas).
①We perform a screening test for the healthy check of the donor.

Donor screening test(ⅰ) Blood type: ABO type and Rh type tests

1

About the conﬁrmatory typing (CT) stage

1）
Schedule adjustment
adjust the schedule after consultation. If the timing proposed by the coordinator is notconvenient for you, please ﬁll out the reply form and inform the coordinator / Donor Center (DC).

(ⅲ) Functional tests of liver, kidney etc.: total serum protein, blood glucose,blood urea nitrogen, creatinine, total bilirubin, GOT, GPT, γ-GTP, cholesterol(ⅳ) Infectious disease test (tests for pathogen that may infect patients via
blood transfusion or hematopoietic stem cell transplantation): syphilis
serum test, hepatitis B, hepatitis C, adult T-cell leukemia virus, AIDS (HIV)virus, cytomegalovirus

Ⅰ Conﬁrmatory typing (CT) Stage

The coordinator will check with you about your intention to donate and your convenience and(ⅱ) Blood count: hemoglobin, red blood cells, hematocrit, white blood cells,
platelets

2）
Interview for conﬁrmatory typing (CT) stage
On the day when you will be undergoing conﬁrmatory typing (CT) stage, the coordinator willbe the primary person to explain to you about the method of donation with the Notice of
Coordination Process (Compatibility notice) that we sent you.
The coordinator will also check with your intention to donate and convenience, if your family
has understood everything and for their consent (your family may sit in during the interview).

②For donors who did not undergo DNA typing of all 8 antigens of HLA -A, B, C, andDR locus when the donor registers with us or in past coordination process, we willconduct a detailed DNA typing in this round of conﬁrmatory typing (CT) to
determine your HLA type to see if it is compatible with the patient.

During the interview for the conﬁrmatory typing (CT) stage, please kindly bring along and③There may be times when we will store a portion of the blood collected from you

show us your identity veriﬁcation documents such as driver s license and health insurance

during the conﬁrmatory typing (CT) to reconﬁrm the results of the tests. We willcard.

discard the blood collected for the conﬁrmatory typing (CT)s (blood, DNA samples)when the necessary testing is completed. However, we may use some of your DNA
samples (after making individual identiﬁcation impossible) to maintain the quality of

Coordination process for donating bone marrow or peripheral blood stem cells for donors◆We will check with you on your intention to donate regarding the method of harvest during theinterview for conﬁrmatory typing (CT) stage.
After the coordinator has explained to you on the diﬀerent harvest methods of bone marrow or peripheral
blood stem cells, the coordinator will ask if there is any method that you cannot accept (if you are unable todecide at this juncture, the coordinator will check with you again via phone within a week s time).
We will not request you to donate bone marrow or peripheral blood stem cells using the method that you
did not accepted.
In the event that you are unable to donate according to the method you have accepted to due to results ofthe conﬁrmatory typing (CT)s or health reasons, the coordination process will end here.
◆Either harvest method will work for the patients but there may be cases where a method is prioritizedover the other (such as bone marrow transplantation or peripheral blood stem cells transplantation).
We will inform you of the patient s preference (priority) if you wish to know, but please kindly understandthat the harvest method is subject to change due to the patient s condition or your intention (if there is any
donation method that you do not accept) etc.

20

HLA testing, or to evaluate reagents used in HLA tests.
④The results of the HLA-DNA typing may also be used for new searches after thecoordination process has ended.

If you are donating peripheral blood stem cells, one of the condition is to locate the blood vessel
which can collect blood in your arms. We will check for that during the medical interview for the
conﬁrmatory typing (CT) stage.

Q How much time does the conﬁrmatory typing (CT) take?
A The time required is about 1 to 2 hours, and will diﬀer depending on the facility. In general,
the tests will be conducted from 9 a.m. to 3 p.m. from Mondays to Fridays.

21

Chapter 2

Results of general blood test

4

Pending selection

We will inform you of the results about 2 weeks after your blood is collected. Please note that

If the results of the conﬁrmatory typing (CT)s indicate that the patient can undergo thethe blood test includes hepatitis, syphilis, AIDS, and other tests.

same extent of transplantation as the selected potential donor, we may ask you to wait forIf the results of your blood test do not meet the criteria of the JMDP, we may talk to you again

a while as your selection remains in a pending status. During this period while you arefor another retest.

pending selection, the progress of the coordination process may change and stretch over
HLA

Data

（DNA）

Screening test

How the Coordination Process Works

2

a long period of time. If there are changes such as health status, environment, or yourschedule/convenience etc. during this waiting period, please notify your coordinator or DC.

Check(See Chapter 2, IV. Termination and Temporary Suspension of Coordination Process)(Notiﬁcation)

3

Potential Donor selection notiﬁcation

Ⅰ Conﬁrmatory typing (CT) Stage

The coordination process for the patient may involve up to 5 donors.
The patient s physician will review all the information (including results of conﬁrmatory typing(CT)s) of all potential donors, and select the potential donor most suitable for transplantation.
This is called donor selection.
It will take about 2 weeks to 2 months before you will be notiﬁed if you have been selected as
the donor.
Please inquire with the district secretary or the coordinator if you wish to know the progress ofthe selection process.

Q Can I know how many a potential donors are being reviewed?
A There are cases where multiple a potential donors have been matched for the patient, and also cases
where not even 1 donor has been found.
The number of a potential donors being reviewed or considered is not revealed to DC staﬀs,
physicians for CT, coordinators, and donors themselves.
This is to preserve the discretion of the donors.

Coordination process for donating bone marrow or peripheral blood stem cells for donors
The harvest method will be decided by the patient side after considering the conﬁrmed intention and thehealth status of the potential donor during the conﬁrmatory typing (CT) stage.
We will inform you of the harvest method once you are selected as the potential donor. After that, we willproceed with the coordination process for you to donate according to that harvest method. As the patientside also starts to prepare for transplantation according to the policy decided in advance, the harvest
method generally will not be changed after the potential donor is selected. In the unlikely event that you or
your family wishes to change the harvest method, the coordination process may be terminated.

22

23

Chapter 2

2

Validity of the letter of the ﬁnal consent

How the Coordination Process WorksⅡ. Final consent

The letter of the ﬁnal consent is valid for 6 months. If for any reason the donor is only able
to donate bone marrow or peripheral blood stem cells 6 months after he/she has signed◎ The interview for the ﬁnal consent will be conducted with you (thedonor), your family, and in the presence of third parties.
◎ We will check and ask again for your ﬁnal decision/intention as well as
your family s consent in the interview for the ﬁnal consent.
◎ You will not be able to withdraw consent after you have signed andstamped your seal on the letter of ﬁnal consent.

and sealed the letter of the ﬁnal consent, the district secretary and the coordinator will

3

Blood collection for testing to verify engraftment

On the day of harvest, 20 ml of blood (not part of the bone marrow or peripheral blood
stem cells harvest) will be collected from you for testing. This is for the transplant center(TC) to conﬁrm whether the donor cells have successfully grafted onto the patient after
transplantation (including genetic analysis) etc. The donor s consent for this blood

1

Meaning of ﬁnal consent

We will arrange to hold the interview for the ﬁnal consent on a date, time, and place once you

4

If health problems arise in the donor after the ﬁnal consent

After the potential donor and the family representative(s) have fully understood the explanations

The JMDP s top priority is the health and safety of our donors. Even if you have given yourprovided by the coordinator and the physicians for CT, and personally signed and stamped theirﬁnal consent, we will either postpone or terminate the harvest procedure if we discoverseals on the letter of consent to donate bone marrow or letter of consent to donate peripheral

health problems in you.

Ⅱ Final consent

are selected as the donor.

collection will be veriﬁed at the letter of the ﬁnal consent.

blood stem cells ( letter of ﬁnal consent ), the donor and family representative are indicating
their ﬁnal intention to donate. Not only the consent of the potential donor, but the understanding
and consent of the family members are also necessary.
The decision to donate bone marrow or peripheral blood stem cells is entirely of the free will of
the potential donor. The potential donor is only allowed to withdraw from the donation process
before he/she signs and seals on the letter of ﬁnal consent; once the donor signs and seals on

If the patient indicates a date/period that he/she wishes to undergo the transplantation while weare arranging for a date to conduct the interview of the ﬁnal consent with the donor, we may
make an informal decision on the harvest schedule and the CC/AC after consulting with thedonor. In this case, after we have veriﬁed the donor s ﬁnal consent, we will proceed with thearrangements concerning the decision.

the letter of ﬁnal consent, withdrawal is not allowed.
Once we have conﬁrmed your ﬁnal consent, the patient side (patient, patient s physician,transplant center (TC)) will begin Pre-transplantation treatment on the patient about 2 weeks
before the transplant procedure on the premise that the patient will deﬁnitely be undergoingtransplantation . If the donor decides to withdraw from the donation after we have conﬁrmed thedonor s ﬁnal consent, the patient may not be able to receive appropriate medical treatment.
Please kindly understand that this ﬁnal consent is very important on many levels.

Q What is a family representative?
A It will be the closest person (parents for singles, spouses for married people) to the donor. Dependingon circumstances, siblings and guardians may serve as family representatives too.

Q hat is the role of having a third-party present in the interview?
A The third-party witness is present at the interview to make sure that the donor and the family representative understand thethorough explanation provided by the coordinator and the physicians for CT, and that the donor wants to donate out of his/her
free will. In principle, the third-party witness is usually arranged by DC, but the donor may request for a related person or
relative to serve as the third-party witness instead.

24

25

Chapter 2

4Managing the physical condition of donors

How the Coordination Process Works

Ⅲ.Once harvest is decided

Please prepare your physical condition as the harvest approaches. For more details,
please read the Donor Handbook (pages 13 to 15) that you have been given when
the harvest was decided.
Please notify us as soon as possible if you need to observe any abnormalities in your◎ A detailed schedule towards the harvest procedure would be decided
once we have veriﬁed your ﬁnal consent.
◎ Please prepare your physical condition as the harvest approaches. You
must notify us if you do not feel well.

1

body or need to take medication from illnesses or accidents etc.

Please do not do stretching exercises (such as training and exercising yourmuscles) about 2 weeks before you are hospitalized (please do not exercise
about a week before you go for your health examination before the harvest
procedure). Exercise may cause abnormal values in your blood test results; it isdiﬃcult to judge whether it is an abnormal value or pathological due to exercise,and this will lead to an emergency since the patient is preparing fortransplantation. If you cannot avoid exercising, please consult your physician
before you go for the health examination.

Blood
donation

Blood donation may aﬀect your blood test values.
Please refrain from donating blood once the coordination process begins, until 6months after the harvest procedure.

Smoking

Please refrain from smoking as phlegm etc. tends to ﬂow out during anesthesia
and obstruct your breathing, and aﬀect the blood test values.
Depending on CC/AC, you are also not allowed to smoke within the hospital andits premises.

Alcohol

Please refrain from drinking as it may aﬀect your liver functions.

Pregnancy

The harvest procedure cannot be performed if the donors becomes pregnant outof concern of the health and safety of the mother and the fetus. Please avoid
getting pregnant until the harvest is completed (as you will be asked to go on
the pill for about 4 weeks before the harvest, please consult with your physician
concerning the medication).

Overseas
travelPlease inform the coordinator or DC of the period and place if you have alreadymade arrangements for overseas travel. Also, please refrain from travelingoverseas about 1 month before the harvest to prevent getting infections.

Vaccinations

Please inform the coordinator, DC, or the physician responsible for harvest of the type
and timing if you have already made arrangements for vaccinations.
<Vaccination for inﬂuenza>
If the donor contracts inﬂuenza, the harvest procedure will be postponed or terminated,
and this will aﬀect the patient. If the donor whose harvest date has been decided (ortentatively decided) somewhere between December to March decides to undergo
inﬂuenza vaccination on a voluntary basis, we will subsidize half the cost, we willsubsidize half the cost so please inform DC or the coordinator.

Nail
art

We may observe the color of your nails in order to check your health status.
Please refrain from nail art (manicure, fake nails etc.) when you are undergoing
the harvest procedure.

Eyelashextensions

During the bone marrow harvest procedure, you will be put under generalanesthesia and your eyelids will be taped shut. If you have eyelash extensions,
we may ask you to remove them before the harvest procedure so please consult
with your physician when you go for health examination before the harvest.

Deciding the harvest facility (CC/AC)

After we have conﬁrmed your ﬁnal consent, Donor Center (DC) will notify the patient s
physician, and CC/AC accredited by the JMDP will be chosen (we will proceed with thearrangements of the facility if it has been decided in advance). While we will consider thedonor s preferences, you may not get to choose to donate in the CC/AC of your choice
due for various reasons. CC/AC is not the same hospital as the transplant center (TC)

2Harvest schedule

DC and the coordinator will arrange the schedules for the harvest and transplant between
the donor, the patient side, and the CC/AC, as well as schedule the dates for healthexaminations, autologous blood collection (if you are donating bone marrow) or G-CSF
injection (if you are donating peripheral blood stem cells) etc.
We will respect the donor s schedule as much as possible but please kindly note that thedate of harvest is limited due to the patient s medical treatment.

3

Changes to the harvest schedule

Depending on the condition and changes in disease in the patient, the harvest andtransplant procedures may not be able to take place on the decided dates. We will readjust
the schedule so that the transplant procedure can be performed on a day when the patient
has gotten better. There have also been cases when the transplant procedure wasterminated because the patient s condition turned for the worse or deteriorated. However,even if the patient does not undergo transplantation, the donor s intention to donate is apillar of support for the patient in his/her ﬁght against the disease (see Chapter 2, IV.
Termination and Temporary Suspension of Coordination Process)26

Ⅲ Once harvest is decided

Sports etc.

27

3Chapter 2

Medical examination

The physician responsible for harvest and anesthetist (only for bone marrow harvest) will
perform a medical examination on you at the CC/AC.

Ⅳ. Termination and Temporary
Suspension of Coordination Process

How the Coordination Process Works

5

In this health examination, we will make inquiries and perform examination, screening test,
urinalysis, chest X-ray examination, electrocardiogram, pulmonary function test (only forbone marrow harvest only) etc. We will also perform a pregnancy test for female donors◎ If you do not meet the requirements to become a donor, or withdraw
from your application to become a donor, the coordination process will
be terminated. We will not reveal the details/reasons to the patients.

after consultation.
We may consult with you again for retest or detailed examination if your test results do notmeet our criteria.

◎ If the coordination process ends due to the circumstances of thepatient such as a change in the disease condition, the coordination
process might be temporary suspended. We will not inform the donorof the details.

Depending on the results, the harvest procedure may be terminated even if you have given
your ﬁnal consent.

1

Ⅳ Termination and Temporary Suspension of Coordination Process

If you are donating bone marrow, see Chapter 3. A

Termination of the coordination process1）Termination of the coordination process due to the donor s circumstances
If you do not meet the requirements (see Chapter 1, III) to become a donor, or

If you are donating peripheral blood stem cells, see Chapter 3. B

withdraw from your application to become a donor, the coordination process will beterminated. The patient will not be informed of the termination reasons at all.

Reasons for termination due to donor s circumstances (example)● When the potential donor is not available● When the consent of the family members cannot be obtained● When the physician discovers health problems with the donor

You will be given a Donor Handbook once the harvest procedure is decided.
Please ﬁll in the necessary columns and bring the handbook with you during medical
examinations and on the day of the harvest itself.
The Donor Handbook details the precautions need to be taken before and after the harvest
procedure, and symptoms that are likely to occur etc.
Also, in the unlikely event that we need to perform emergency measures for some reason
before or after the harvest procedure, please ﬁll in your contact information.
Please keep the Donor Handbook as a record of being a bone marrow or peripheral blood
stem cells donor, even after the coordination process has ended.
Please show this handbook to the medical institutions when you visit the hospitals which is
not CC/AC, or go for medical examinations after the harvest procedure is completed. Pleasecontact the JMDP Donor Center(DC) if you have any health problems of which the causal
relationship to the harvest procedure cannot be denied.

282）Termination of the coordination process due to the patient s circumstances
There have been cases where the coordination process was terminated due to thepatient s circumstances. The donor will not be informed of the termination reasons at all.
Reasons for termination due to patient s circumstances (example)● When the HLA (DNA) typing does not match● When another a potential donor is selected/decided● When the medical treatment of the patient changes due to changes in the disease state etc.

29

Chapter 3

Chapter 3. Harvest
A. Bone marrow harvest
After the coordination process ends, the status of the donor registration is either changed
to Continuous , Suspended , "or Canceled . When your status is Continuous , a newcoordination process may start immediately. To avoid this, your status will be changed toHarvest3）Donor registration after the coordination process ends

Ⅰ. Schedule of bone marrow harvest

Suspended or Canceled for a certain period of time after the coordination process ends
based on your circumstances.
If the coordination process is terminated due to circumstances on the patient side, your◎ Usually, you will be hospitalized for 4 days 3 nights for the harvest procedure.

status in general will remain as Continuous .

◎ Before you are hospitalized, you will need to undergo a health examination (upto 21 days before the harvest procedure), and get you autologous bloodcollected (1 to 3 weeks before the harvest procedure) if necessary.

In the event that the coordination process has ended from the patient side after conﬁrming the yourﬁnal consent, and you are selected again soon afterwards to be a donor for another patient with the
new coordination process already started, we may not interview you again for your ﬁnal consent.

For bone marrow harvest, you will be hospitalized 1 to 2 days before the day of
harvest, and generally is discharged 2 to 3 days after the procedure. For speciﬁcmatters concerning the hospitalization, please check with the coordinator or thephysician responsible for the harvest in the CC/AC in advance.

Patient

2

A. Bone marrow harvest

In the event that a new coordination process is started after the earlier coordination
process has ended, you will have to undergo another around of conﬁrmatory typing (CT)s(or just the screening test) even if the same tests were performed in the previous round.
However, if a new coordination process starts within a year from your last round of
conﬁrmatory typing (CT)s or medical examinations, then you may not need to undergo
another round of conﬁrmatory typing (CT)s.

Bone marrowtransplantation

Pretransplantation
treatment

Preparations

Suspension of coordination process
Up to 21 days before

1 to 3 weeks before

1 to 2 days before

After 2 to 3 days

After 2 to 3 weeks

suspended. As you may be asked to wait for a certain period of time (maximum of 3
months), please let us know if it is inconvenient for you. We will contact you as soon as the

Donor

Final
consent

Autologous
blood
collection

Medicalexamination

patient is ready to resume the coordination process. If it looks unlikely that the coordination

Bonemarrow
harvestHospitalization

Ⅰ Schedule of bone marrow harvest

Depending on the circumstances of the patient side, the coordination process might be
Medicalexamination
after harvest

Discharge

can be resumed, the coordination process will be terminated.
We will not inform you of the reasons why the process is suspended.

Hospitalization schedule
2 to 4 hours

Reasons for suspension due to patient s circumstances (example)● When it is necessary to consider whether to perform the transplant procedure due tochanges in the patient s condition

Actualday

Day after
Discharge

WalkingLight meals( To the ward)

Waking up

Bone marrow harvest

Anesthesia( To the operating room)

Injection (premedication)

Intravenous drip

Enema

Fasting

30

Tests

When the coordination process is suspended and the results of the conﬁrmatory typing(CT)s indicate that the patient can undergo the same extent of transplantation as the selecteddonor, we may ask you to wait for a while as your selection remains in a pending status.
(See Chapter 2, I. Conﬁrmatory typing (CT))

Day before
Hospitalization● When the patient needs to receive another form of medical treatment before transplantation
because the patient s condition is unstable<Operating room>31

Chapter 33）Volume of bone marrow ﬂuid during harvest

HarvestⅡ.Follow-up from preparation for bonemarrow harvest to after the procedure is over

The target harvest volume is 15 ml per kg of potential donor s body weight; a volume
that is set such that it will not impose a burden on the donor s body. Your body s ability
to generate blood will not drop because you donated bone marrow. The number ofhematopoietic stem cells in your bone marrow will regenerate blood promptly.

◎ The JMDP will perform the harvest procedure according to strict safety standards.

3◎ We will collect your autologous blood according to the volume of bone marrow to
be harvested in advance.

Since your iliac will be punctured with a thick needle many times in order to aspirate the◎ You will undergo general anesthesia for the harvest procedure. We will inject aneedle right into your iliac (pelvic bone) and aspirate the bone marrow ﬂuid.

procedure from being transported into to being transported out of the operating room lastsbone marrow ﬂuid with a syringe, most donors undergo general anesthesia. The wholeabout 2 to 4 hours, to which you will be anesthetized for about 1 to 3 hours.

◎ You will be discharged 2 to 3 days after the harvest procedure, and the follow-up
will begin from there.

If we need to perform emergency measures on the donor during anesthesia, we willterminate the harvest procedure immediately and perform the necessary medical treatment.
1）Treatment before anesthesia

Autologous blood collection

A. Bone marrow harvest

1

Anesthesia

We will administer you with a preanesthetic agent before putting you under general

In order for the donor to get anemic from the bone marrow harvest procedure, we will collectanesthesia. We will also secure an intravenous drip route in you to administer various

autologous blood from the potential donor about 1 to 3 weeks before the day of harvest.

drugs and for transfusion. Depending on the facility, we may perform enema and hair

Depending on the planned volume of bone marrow to be harvested, we may need to collect theremoval (hair shaving etc.) too.

necessary volume of autologous blood in 1 to 2 rounds (200 to 400 mℓ each round).

2）Management during anesthesia

We may prescribe you with a hematopoietic agent (iron preparation) during that time.
Your autologous blood is refrigerated, stored, and transfused back to you on the day of harvest.
be harvested.

drug, we will insert a soft plastic tube into your trachea through your mouth to deliver

Ⅱ Follow-up from preparation for bone marrow harvest to after the procedure is overWe may not collect your autologous blood depending on the planned volume of bone marrow toOnce you start to lose your consciousness after being injected with the anesthesia-inducing
anesthetic gas and oxygen, and control your breathing with an artiﬁcial respirator. In manycases, we may also insert a thin tube (balloon catheter) into your urethra to conduct the urine
out of your bladder (urethral catheterization). We will check the volume of urine passed out

2

Harvest1）
Site of harvest

during anesthesia to help us get an accurate picture of the state of blood circulation and renal
Site ofharvestlungs during anesthesia (accidental swallowing), we may insert a thin tube (stomach tube)
from your nose into the stomach.

The bone marrow ﬂuid is easily harvested from the iliac (pelvic bone).
It is in an area slightly below the back of your waist in the pelvis.

function in your body. Also, to prevent the contents of the stomach from ﬂowing back into the

Iliac

During anesthesia, we will regularly measure your blood pressure, which will be continuously
and rigorously observed by the anesthesiologists with the electrocardiogram monitor etc.

2）Harvest method
You will be asked to lie facing down in the operating room, and punctured
with a bone marrow aspiration needle (the size of the bore is about that of a ballpoint pen) fromthe surface of the skin. A few ml of bone marrow ﬂuid is aspirated with a syringe at a time. We
may make a small incision on your skin so that it is easier to puncture the skin with the aspirationneedle. There will be a total of about 2 to 6 punctures on the back of your pelvis; 1 to 3
puncture on each side. While we will puncture your pelvis in dozens to hundreds of places toaspirate the bone marrow ﬂuid, the punctures in your bone will naturally and automatically heal.

32

attached to your body.
Once we have conﬁrmed that you are healthy from the health examination conducted before the harvest procedure,
we may ask for you and your family members to sign on the letter of consent etc. prepared by the CC/AC.
* Examples of letter of consent prepared by the CC/AC (will diﬀer depending on the facility)○ Consent Form for Surgery○ Consent Form for Anesthesia○ Consent Form for Blood Transfusion : consent regarding autologous blood transfusion (including thepossibility of transfusing allogeneic blood (blood from other people) if unforeseen circumstances happen during thebone marrow harvest procedure)

33

Chapter 3

Ⅲ.Safety and complications ofbone marrow harvest (anesthesia)

Symptoms after harvest* More details in Chapter 6. References .

1）
Symptoms after waking up from anesthesia
You may experience urinary pain after removing the urinary catheter, headaches, sore

Harvest4

throat, nausea, and run a fever of 37 to 38 degrees after withdrawing the tracheal tube.

◎Complications etc. may occur during the harvest procedure but wewill perform the appropriate medical treatment.

These symptoms will usually go away within 1 to 2 days.
2）
Pain in the harvest site (waist)
There are individual variation and each donor experiences a diﬀerent degree of pain. Most
donors have continued to experience some pain up to a week after the harvest procedure
is over, and there have been some donors who felt the pain for a month and above. In rarecases, the skin where the bone marrow aspiration is performed may form pus or bleed but

1Complications associated with bone marrow harvest and anesthesia* More details in Chapter 6. References .

The following complications have been reported in the past.

this will be handled appropriately by the attending physician. There may be marks of theTransient ： owered blood pressure, arrhythmia

aspiration needle on your skin, but they will gradually fade away.

Others： Suspected complications include anterior teeth trauma, breakage of the bone marrow aspirationneedle, laryngeal granuloma, urethral injury, thrombosis and pulmonary fat embolism; a transient paralysis of the left

A. Bone marrow harvest

5

half of the body after awakening from anesthesia; a hematoma occurred in the retroperitoneum and the left ilio-lumbar

Discharge (return to daily life)

region after completing the harvest procedure; onset of hepatitis C in the donor after the harvest procedure; pain andnumbness in the harvest site or the gluteal region (buttocks) lasted for a prolonged period of time.

Usually, you will be discharged from the hospital in about 2 to 3 days after the bonemarrow harvest procedure is over, and can resume work or school.

While this is not a case of bone marrow donation via the JMDP, one case of malignant hyperthermia has

However, please keep the wound clean for about a week after the harvest procedure, andbeen reported as a complication in a bone marrow donor who underwent general anesthesia between

avoid excessive exercises and extreme sports.

relatives. However, the donor was discharged from the hospital after 3 weeks without no aftereﬀects (1996).

62

Serious accidents caused by bone marrow harvest and anesthesia

The coordinator will check with your physical condition via phone after you are discharged.

There have been 5 cases of deaths reported in bone marrow donors worldwide.

You will undergo a medical examination at the CC/AC 2 to 3 weeks after the harvest

We at the JMDP have helped to coordinate 1,300 cases of bone marrow harvests

procedure.

between unrelated individuals in Japan and no deaths in donors have yet to occur.

Ⅲ Safety and complications of bone marrow harvest (anesthesia)

Follow-up after harvest

We will also send you a questionnaire about 3 months after you have donated bonemarrow; please kindly ﬁll up that questionnaire.

In the unlikely event that an abnormality appears in your health condition, the physician in charge of the
CC/AC will take responsibility and attend to you to administer medical treatment. Please consult early andreceive treatment. In that case, we may consult with you about the use of your own health insurance
card.

■Bone marrow donor death cases (partial modiﬁcation including errors in the sources)
Case

Countryof origin

Blood relative/
Unrelated individual

Age/SexTime ofincidence

Cause of death

Source1Overseas

Blood relative

57 years old,
femaleDuring theprocedure

Ventricular ﬁbrillation during the harvest procedure(heart failure) (there had been abnormal ECG readings.)

1）2Overseas

Blood relative

Unknown,male

During theprocedure

Diﬃculty in breathing due to the sensitivity reaction
toward anesthesia (anaphylactic shock)

1）

3

Japan

Blood relative

35 years old,male

During theprocedure

Respiratory arrest while under anesthesia (therespiratory arrest caused cranial neuropathy.)

1）

4Overseas

Unrelatedindividual

35 years old,male

After theprocedure

Pulmonary embolism (lower extremity thrombosis
occurred, causing pulmonary embolism.)

1）

5

Overseas

Blood relative

38 years old,male

After theprocedure

Severe pulmonary embolism (donor was diagnosed
with antithrombin III deﬁciency in the past, and thiswas revealed by the donor s family after death)2）

Source1）Hematopoietic Cell Transplantation, 1999, 2nd Edition, Chapter 40. Bone Marrow and Peripheral Blood Stem Cell Donors)
2）Haematologica l 2009; 94(1), Severe events in donors after allogeneic hematopoietic stem cell donation)

34

35

Chapter 3

B. Peripheral blood stem cells harvest

Ⅱ.Follow-up from preparation for peripheral blood
stem cells harvest to after the procedure is over

◎ You will be hospitalized for about 5 days 4 nights to 7 days 6 nights if you
receive the G-CSF injections.

HarvestⅠ.Peripheral blood stem cells harvest schedule◎ The JMDP will perform the harvest procedure according to strict safety standards.

◎ You will need to visit the hospital for about 2 to 4 days if you receive the
G-CSF injections, and will be hospitalized for about 2 days 1 nights to 4 days 3nights after the injections.

◎ We will inject you with G-CSF every day for a period of 3 to 4 days before the day of
harvest to increase the number of hematopoietic stem cells in your peripheral blood.
◎ We will harvest by using a blood component separation device. Depending on thenumber of peripheral blood stem cells harvested, we will decide if it is necessary to
perform a second round of harvest the next day.

◎ You will undergo a health examination up to 21 days before the day of harvest.
The days you will be hospitalized will depend on the facility(CC/AC). You will be hospitalized for◎ You will be discharged at most 2 days after the harvest procedure, and the follow-up
will begin from there.

about 5 days 4 nights to 7 days 6 nights if you receive the G-CSF injections, and for about 2days 1 nights to 4 days 3 nights if you visit the hospital to receive the injections instead.
physician in the CC/AC in advance.

Patient1

Preparation

G-CSF injections

The G-CSF is a drug that increases the number of your white blood cells. The number of

Peripheral blood
stem cells
transplantation

Pretransplantation
treatment

hematopoietic stem cells will increase in your peripheral blood (blood ﬂowing throughout the body)when you are injected with G-CSF 1 to 2 times a day for a period of 3 to 4 days before the harvest.

(Conditioning regimen)

If you intend to visit the hospital to receive the G-CSF injections
instead, the coordinator will check with your physical condition* If suﬃcient cells
are harvested

Performed up to 21 days
before day of harvest〈On day 4 or day 5〉•G-CSF injection•Peripheral blood stem
cells harvest

Receive G-CSF
injections over
3 to 4 days

Medicalexamination

About 1 to 4
weeks later

Hematopoietic
stem cells

via phone after you return home. Also, please bring along yourDonor Handbook (see page 28), and contact the listed contact

Discharge

Medicalexamination
after harvest

information if you observe any abnormalities in your health2* If insuﬃcient cells
are harvested〈On day 5 or day 6〉•G-CSF injection•Peripheral blood stem
cells harvest

Ⅰ Peripheral blood stem cells harvest schedule
Ⅱ Follow-up from preparation for peripheral blood stem cells harvest to after the apheresis procedures is over

Final
Donor
(potential Donor) consent

B. Peripheral blood stem cells harvest

For more speciﬁc details regarding the hospitalization, please check with the coordinator or theHarvest1）Day of harvest
We will harvest your peripheral blood stem cells on day 4 or 5 after we you havereceived G-CSF injections (the schedule will diﬀer depending on the facility).

Hospitalization schedule2）Harvest method
The harvest procedure will usually be performed 3 to 4 hours after the G-CSF injections. There
are also facilities who will not administer any G-CSF injection on the actual day of harvest itself.

1 to 4 days prior

Day of harvest

Discharge* If a second round of
harvest is performed

Discharge or second
round of harvest* Depending on the cellcount harvested on theprevious day

Determining cell countHarvest (3 to 4 hours)

Venipuncture(G-CSF injections)

Hospitalization* From day 1 of injection
to the day of harvest

G-CSF injections(3 to 4 days)

36

Following 2 days later
day

Before harvesting, we will try our best to locate a thick vein in both arms (or one arm) andpuncture you with a needle to collect and transfuse blood.
We will only collect the hematopoietic stem cells in your blood using a blood component
separation device and transfuse the rest of the blood into another vein. During the harvest
procedure, you will not be able to move the arm with the needle. The time required is about 3
to 4 hours. However, the procedure may take more time depending on the situation.

37

Chapter 3

The safety of our donors is our top priority during the harvest procedure. Medical staﬀ such as
will perform regular checks on your physical condition including blood pressure measurement.
3）Femoral vein accessOne of the condition to becoming a peripheral blood stem cell donor is the presence of a
relatively thick blood vessel on the arm. In rare cases, even if we have located andconﬁrmed the presence of a thick vein in the arm during the conﬁrmatory typing (CT)stage or the Medical examination , but am unable to secure this blood vessel on the dayof harvest, we may insert a catheter (soft tube) into the blood vessel in your groin (thearea which connects to your leg). This is called femoral vein access (see page 39).
We will ask for consent in the letter of ﬁnal consent regarding femoral vein access. If thedonor does not agree to this, the donor will be unable to donate peripheral blood stem
cells.

The volume of processed blood is set in a range that will not impose burden on thedonor s body.
The target volume to be circulated in the blood component separation device is 200 mlof blood for every kg of the donor s body weight, with the upper limit of 250 ml/kg.
If the donor has a body weight of 50 kg, about 10 to 12.5 L of blood will be circulated
in the blood component separation device.

＜Speciﬁc treatment＞◎Disinfect the skin around the site where the catheter is inserted.
◎Apply local anesthesia to the site of puncture and insert the catheter into thevein.
* Depending on the facility, we may remove the hair or make a small incision on the skin to allow easier insertion of thecatheter before the treatment. Also, we may aﬃx the catheter to the skin with a string to prevent it from moving around.

＜Complications during catheter insertion＞◎ Arterial puncture: To pierce the needle into an artery located alongside avein. When this happens, the nurse or phlebotomist will apply pressure on
the artery to stop the bleeding. Treatment is rarely necessary, but bleeding
may result in blood clots (hematoma) ﬂowing back into the abdomen, which
will require treatment.
◎ Others: There have been cases of air embolism (accidentally introducing air

B. Peripheral blood stem cells harvest4）Amount of blood circulated in the blood component separation device (volume of processed blood)

HarvestFemoral vein access

physicians, nurses, and clinical engineering technologists will constantly be on standby, and they

into the blood vessel during the insertion of catheter) and nerve damage
near the veins etc.
＜Complications during catheter placement＞◎ Bacterial infections etc. may occur. When infections happen, we will remove
the catheter and proceed with treatment such as administering antibiotics.
◎A thrombus (blood clot) may form in the area surrounding the catheter.

5）Number of rounds of harvest

Ⅱ Follow-up from preparation for peripheral blood stem cells harvest to after the apheresis procedures is overWe will determine the peripheral blood stem cell count harvested after the apheresis
procedures is over. We will terminate the procedure if we have harvested suﬃcientamount for the patient s transplantation. If an insuﬃcient amount is harvested, you will
undergo a second round of apheresis procedures on the next day.
Femoral artery
Femoral nerve
Femoral vein

38

39

3

Chapter 3

Symptoms after harvest

1）
Reduction of platelets
Platelets are also collected during the harvest of peripheral blood stem cells. If the platelet

Ⅲ.Risks and discomforts of
the apheresis procedure

Harvest3

count decreases below the reference range, we may separate the blood platelet components
from the harvested peripheral blood stem cells and transfuse the blood back into you via
intravenous infusion. Since platelets play a role in blood coagulation, you may ﬁnd yourself
more prone to bleeding for several days after the harvest. However, the coagulation process◎Complications and side eﬀects may occur with peripheral blood
stem cell harvest but appropriate measures will be taken.

will usually return to normal in a few weeks.
2）Site of harvest (arm)The puncture site, and the area around it, may swell up or bruise but this will usually subside
in 1 to 3 weeks.

1Side eﬀects of G-CSF* More details in Chapter 6. References .

Discharge (return to daily life)

B. Peripheral blood stem cells harvest

4

The following side eﬀects may occur with G-CSF injections.
Depending on the increase of white blood cell count or decrease of platelet countAfter we have checked your health condition and discharge you from the hospital (at most the

beyond the reference range, and the extent of side eﬀects, we may reduce the

day after the harvest procedure is over), you may be able to resume work or school. However,dosage or discontinue the administration of G-CSF.

please refrain from excessive exercises and extreme sports for about a week after the harvest.
①Possible mild side eﬀects

5

Follow-up after the harvest

Bone pain (back pain, chest pain, back pain, joint pain, muscle pain, etc.), headache,
lowered blood pressure, rashes, erythema (red spots), nausea, vomiting, fever,malaise, loss of appetite, palpitations, abnormal liver functions, increased uric acidweeks after the harvest is over.

level, renal dysfunction (increased serum creatinine level), and temporary enlargement

You will undergo a medical examination at a CC/AC 1 to 4 weeks after the harvest.

of spleen.

Also, we will send you a questionnaire 3 months after the harvest procedure, and once a
year for 5 years to help us ascertain the long-term safety of G-CSF. Please kindly help us ﬁllup the questionnaires.

Ⅲ Risks and discomforts of the apheresis procedure

The coordination will check with your physical condition via phone once a week for up to 4

* Pain will usually subside with pain killers etc.
In most cases, these symptoms will go away within a few days after the G-CSF injections.

②Signiﬁcant side eﬀects considered to be related to G-CSF injections
Shock thought to be caused from allergy to G-CSF, interstitial pneumonia, angina

The coordination will check with your physical condition via phone once a week for up to 4
weeks after the harvest is over.
You will undergo a medical examination at a CC/AC 1 to 4 weeks after the harvest.
Also, we will send you a questionnaire 3 months after the harvest procedure, and once a year
for 5 years to help us ascertain the long-term safety of G-CSF. Please kindly help us ﬁll up thequestionnaires.

40

pectoris, cerebrovascular disorder, splenic rupture, acute iritis, gouty inﬂammation suchas gouty arthritis.

41

Chapter 3

Long-term safety of G-CSF

4

G-CSF was approved in 1991 and is an extremely safe preparation that is widely used as
an eﬀective drug for the lowered white blood cell count after treatment with anticancer
drugs in cancer patients. We have been collecting scientiﬁc data because the long-term
safety (over several decades) of its usage has not been conﬁrmed in healthy people. In a
study conducted by the Japan Society for Hematopoietic Cell Transplantation, there havebeen reports of donors who experienced health problems several months to several years
after they underwent the harvest procedures, but its causal relationship to peripheral blood
stem cells harvest has yet to be established. More details in Chapter 6. References .

There have been 12 cases of deaths reported in peripheral blood stem cells donors
worldwide. As many of these were due to some risk factors such as high age of donors, andthe original presence of had illnesses, the causal relationship with peripheral blood stem cell
harvest is not clear. In Japan, peripheral blood stem cell transplantation between blood
relatives began in 2000, and about 500 cases are performed annually. The JMDP started tocoordinate peripheral blood stem cell transplantation between unrelated individuals from2010 onwards, and no deaths in related or unrelated donors have yet to occur.
■ Peripheral blood stem cell donor death cases
Blood relative/
Unrelatedindividual

Age/SexTime of incidence

1

Overseas
1997
and earlier

Related61
years old,
female4 daysafter harvest

2

Overseas
1997
and earlier

Related57
years old,
femaleWithin 24 hours
after returning home3

Overseas
1996

Related64
years old,male

After G-CSF
administration
has ended

4

Overseas
1998

Related73
years old,male

Several days
after harvest

5

Overseas
2000
and earlier

Related67
years old,male

Approximately day
6 after G-CSF
administration

Subdural hematoma

6

Overseas
1999

Related47
years old,male

Day 4 after G-CSF
administration

Sickle-cell anemia crisis

7

Overseas
2000
and earlier

RelatedUnreported,male

Unreported

Cerebrovascular disorder

reﬂex (VVR), nausea, vomiting, lowered blood pressure

8

Overseas
unknown

Related43
years old,male

Passed awayin 15 days

Cardiac arrest* The numbness around the mouth and in limbs are due to the eﬀects of anticoagulants (hypocalcemia) that areused to prevent the blood circulating in the blood component separation device from coagulating. In many cases,
the symptoms will improve with the administration of a calcium preparation.

9

Overseas
unknown

RelatedPassed awayin 17 days

Cardiac arrest

10

Overseas
2001
and earlier

Related50
years old,
femaleAfter catheter
was removed

11

Overseas
unknown

Related27
years old,male

During harvest

12

Overseas
2011

Unrelated

21
years old,
femaleDuring harvest

Complications associated with peripheral blood stem cell harvest* More details in Chapter 6. References .

The following symptoms may occur during the peripheral blood stem cell harvest procedure.

General malaise, numbness around limbs, mouth, dizziness associated with vasovagal

There has been a case where the harvest procedure was terminated midway in peripheral
blood stem cell donor for relatives, but the donor has since recovered with no aftereﬀects.
This was a case where an elderly donor was taking medication due to illness, and theprocedure was probably terminated due to severe vasovagal reﬂex (VVR).

52
years old,male(harvested on day 4 and day 5)(date of death unknown)(date of death unknown)

Cause of death
Cardiac insuﬃciency

Source(donor had bronchial asthma, high bloodpressure and coronary artery disease)2）
3）

Apoplexy(past history unknown)

2）

Myocardial infarction

1）(donor had coronary artery disease)

Cerebrovascular disorder(donor had a history of high blood pressure
and angina pectoris)(donor had a history of abdominal aortic
aneurysm surgery and myocardial infarction)(donor had a history of sickle cell anemia)(past history unknown)(correlation between the harvest and highblood pressure and/or smoking unknown)(correlation between the harvest and smoking
unknown)

3）

3）

3）

Ⅲ Risks and discomforts of the apheresis procedure

Countryof origin

B. Peripheral blood stem cells harvest

Case

There was a case reported when a Japanese donor passed away one year after donating
peripheral blood stem cells to a blood relative in 2003 from the development of acute
myelogenous leukemia. The Japan Society for Hematopoietic Cell Transplantation investigated thecausal relationship between the death and G-CSF, and determined that the incidence of bloodtumors such as leukemia is not diﬀerent to that of in bone marrow donors.
Even in overseas studies, the incidences of reports of blood tumors such as leukemia in thegeneral population, and in bone marrow donors and peripheral blood stem cells donor were thesame. The studies therefore deny the increased risk of developing leukemia from G-CSF
injections.

3

Serious accidents caused by peripheral blood stem cells harvest

Harvest

2

3）
4）
4）

Air embolism(surgical error occurred during the harvest
procedure in which the catheter was inserted
into the internal jugular vein instead)

Cardiac arrest(surgical error occurred during the harvest
procedure)

3）

4）

Bled to death(surgical error in which the catheter was inserted
into the internal jugular vein instead, resulting ininternal bleeding from the blood vessel into the lungs)

5）

Sources:
1) Anderlini P et al.: Allogeneic blood cell transfusion: Considerations for donors. Blood 90: 903-908, 1997.
2) Confer DL & Stroneck DF: Bone marrow and peripheral blood stem cell donors. In Hematomoietic Cell Transplantation.
Edited by Thomas ED, Blume KG, Forman SJ. Blackwell Science, Inc. Massachusetts, USA, pp 421-430, 1999.
3) Corporate information
4) Halter, Kodera, Ispizua: Severe events in donors after allogeneic hematopoietic stem cell donation.
5) World Marrow Donor Association (WMDA) information

42

43

Chapter 4

Chapter 4. Other Matters◎ The harvest method from donors will diﬀer signiﬁcantly between bonemarrow transplantation and peripheral blood stem cells transplantation.
◎ The transplantation method will be selected after considering therespective characteristics of the patient.

1

2

From the patient s standpoint

Other Matters

Ⅰ. Diﬀerence between bone marrow transplantationand peripheral blood stem cells transplantation

1）Characteristics of transplantation method
It is the same transplantation method via intravenous drip but they each have theirown characteristics.
For example, it is known that peripheral blood stem cell transplantation increases
GVHD more than bone marrow transplantation because a higher amount of donor
lymphocytes is transplanted.
However, on the other hand, when a strong GVHD occurs, it has also been said that
the GVL eﬀect (graft versus leukemia eﬀect) where donor lymphocytes attack and kill

From the donor s standpoint

the remaining cancer cells in the patient s body is also high, and a reduced

Subjective symptoms such as pain will start to occur in bone marrow donors after the harvest procedure,recurrence rate can be expected.

and in peripheral blood stem cells donor after they received G-CSF injections.
In an overseas questionnaire study of donors who participated in a comparative study of bone marrow

Donor lymphocytes

Also, it has been shown that there is no diﬀerence in the incidence of serious complications between bonemarrow harvest and peripheral blood stem cells harvest (from a joint survey conducted by the Japan Societyfor Hematopoietic Cell Transplantation and the European Society for Blood and Marrow Transplantation).

《GVL eﬀect 》《GVHD》

Attacks remaining cancer
cells in the patient s body

Attacks remaining cancer
cells in the patient s body

Ⅰ Diﬀerence between bone marrow transplantation and peripheral blood stem cells transplantation

harvest and peripheral blood stem cells harvest, the intensity and duration of pain were almost equal.

After understanding the diﬀerences between these two harvest methods, please consider which harvest
method that you cannot agree to.
■Diﬀerence in peripheral blood stem cells harvest
Bone marrow harvest

Peripheral blood stem cells harvest

G-CSF injection

No

Yes

ApheresisNo

Yes

Autologous
blood collection

Yes (no in some cases)

No

General anesthesia

Yes

No

Hospitalization

Usually
4 days 3 nights◎ Hospitalized for about 5 days 4 nights to 7 days 6 nightsfrom the day you receive G-CSF injections◎ Hospitalized for about 2 days 1 night to 4 days 3 nights
if you visit the hospital for G-CSF injections

About 170 facilities

About 90 facilities (about 100 facilities planned in future)(may diﬀer depending on facility)

Number of harvest
facilities (CC/AC)
Number of hospital visits
for interviews, tests andharvest procedure

About 7 times◎ If you are only hospitalized for the harvest procedure,
about 8 times◎ If you are hospitalized right from the day you receive G-CSF
injections, about 5 times

Reference material: Illustrated series on hematopoietic stem cell transplantation for informed consent authored by Yoshinobu Kanda (1st edition issued on Oct 30, 2009)

Glossary

44

Apheresis: A procedure that draws blood from a blood vessel in the arm, collects only thenecessary cells with a blood component separation device, and transfuses theremaining blood back into the donor.

2）Trend of choice in medical ﬁeld
For patients with aplastic anemia and pediatric patients who do not require much GVL
eﬀect, bone marrow transplantation is the easier choice. Conversely, in patients withadvanced leukemia and infections, as well as elderly patients where the GVL eﬀect is
expected to occur, mini transplantation procedure using peripheral blood stem cells
tends to be chosen instead.

Glossary
Lymphocyte ： A type of white blood cell that is responsible for immune function.
Mini transplantation ： A non-destructive bone marrow transplantation procedure with lesser Pre-transplantation
treatment (Conditioning regimen).

45

Chapter 4

Ⅲ.Donor registration after bone marrowand peripheral blood stem cells harvest◎ Donor registrations will be suspended for one year after the harvest,
and will not be used in compatibility searches with patients. Afterone year, as long as there is no speciﬁc request by the donor, thedonor registration will continue and compatibility search will resume.

◎The JMDP in principle does not approve of freezing and storing bonemarrow or peripheral blood stem cells for transplantation.

The bone marrow and peripheral blood stem cells harvested from donors may be frozen andstored in the following cases.

Other Matters

Ⅱ.Freezing of bone marrow andperipheral blood stem cells

1

Donor registration one year after harvest

1）When there is a sudden change in the patient s condition immediately before
transplantation etc.
While extremely rare, the bone marrow or peripheral blood stem cells may not be used fortransplantation even if they have been frozen and stored. The cells are to be discarded insuch cases.
2）
When a large number of peripheral blood stem cells is harvested
In peripheral blood stem cell harvest, the surplus cells may be frozen and stored if the

Ⅱ Freezing of bone marrow and peripheral blood stem cells Ⅲ Donor registration after bone marrow and peripheral blood stem cells harvest

One year after the harvest, subsequent donor registration will be suspended orcanceled, and a letter will be sent to inform you of the continuation of the registration.
If you wish to check your registration status, or if you do not wish to continue theregistration, please contact the Japanese Red Cross Society Block Blood Center assoon as possible. Also, we will not send letters to donors who are 55 years old andhave received notiﬁcation from the Japanese Red Cross Society that their donor
registration (overage) has been canceled.

2

Number of donations

patient s physician decides that the number of harvested cells exceeds the single

骨At the JMDP, you may donate bone marrow and peripheral blood stem cells up totreatment amount for the patient and that further treatment is required. Even in such

two times in total, irrespective to blood relatives or unrelated individuals. If you havecases, the cells are to be discarded promptly as soon as the physician determines that

donated twice, your donor registration will be suspended until the policy of number ofthe cells will not be used, and are not to be used for purposes other than treatment.

times of donation in future is decided.
At present, in order to collect scientiﬁc data to ascertain the long-term safety of
G-CSF, donors can only donate bone marrow twice, and peripheral blood stem cells
once (if you have already started on G-CSF injections even if the harvest procedure is
terminated, it will be counted as one time of peripheral blood stem cells donation).

46

47

Chapter 4

Ⅴ.DLI (Donor Lymphocyte Infusion )Other Matters

Ⅳ.Protecting the privacy ofdonor and patient

DLI (Donor Lymphocyte Infusion) is a treatment method in which thelymphocytes (white blood cells) of the donor s bone marrow or peripheral
blood stem cells are harvested in the same way as whole blood donations or
blood components donations, and the donor lymphocytes are then◎In order to preserve the privacy of donors and patients and theimpartiality of the JMDP operations, we will not inform you of
information that will identify the patient or the donor, or the
post-transplantation process.decided for each donor.

transfused into the patient.
Among the complications that occur in patients after transplantation, DLI has
been clearly shown to be eﬀective for EB virus and B-cell lymphoproliferative
disorders as well as the recurrence of leukemia.
When the patient requires DLI after transplantation, we may ask the donor toprovide lymphocytes after reviewing the symptoms. During that time, we will

1

Information of donor and patient

conﬁrm the donor s desire again separately from the consent on donatingbone marrow or peripheral blood stem cells.
Please let us know if you do not wish to donate donor lymphocytes.

addresses and names, and the donor will also not be informed of the post-transplantation* This is the same for coordination with overseas patients.

Ⅳ Protecting the privacy of donor and patient Ⅴ DLI (donor lymphocyte infusion therapy) Ⅵ Storing your samples

Donors and patients will not be informed of each other s personal information such asprocess of the patient in principle. However, the coordinator may inform the donor of thepatient s sex, age, and region of residence if the donor wishes to after giving the ﬁnal
consent. Similarly, the patient s physician will also not inform the patient of such information.

2

Information disclosure

Ⅵ.Storing your samples

If you are giving an interview on medium that may be accessed by an unspeciﬁed number

Various studies are being conducted to improve the performance ofof people such as the Internet (including blogs and social network services), bulletin

hematopoietic stem cell transplantation. The Japanese Red Cross Society ismagazines, newspapers, please do not disclose information such as date and time andcurrently implementing a project to store a portion of the blood donated byvenue that may make it possible to identify yourself or the patient. Please contact the JMDP

the donors and patients who have agreed to participate in this project, andDonor Center (DC) in advance when you receive interviews from the press media etc.

to give it to researchers who aim to develop medical treatment for

You can talk about this to the people around you (family and colleagues).

transplantation. The JMDP is also taking part in this project. You can checkwith the person in charge of the CC/AC for more details.

3

Exchanging letters with the patient

After the harvest procedure, you can exchange letters with the patient via DC or thecoordinator. You can exchange up to 2 letters within a year after the harvest procedure isover. Please refrain from writing information that will identify yourself or the other such as
names, addresses, and dates of birth.
We cannot help with the exchange of money or goods. We will deliver the letter after
conﬁrming the contents of your letter, but please kindly understand that the patient may
not always reply to you (this is the same for coordination with overseas patients).

48

49

Fees and Compensation

Ⅰ.Cost burden of donors

Fees and Compensation

Ⅶ.Disclosure of information when
genetic information etc. of donor is
obtained from the donation of bonemarrow or peripheral blood stem cells

Chapter 5

Chapter 5◎ Medical expenses for harvesting the bone marrow or peripheral
blood stem cells will be paid for by the patient s health insurance
so the donor does not need to bear any cost.
◎ We will pay the actual transportation fees.

A blueprint that creates the body is called a gene, and the genes gathered in each cell iscalled a chromosome. Changes in the chromosomes (genes) cause various diseases. In
rare cases, even a healthy person may be born with altered chromosomes. For example,
even if the person does not exhibit any symptoms now, there may be changes in his/herchromosomes that may cause various symptoms (such as infertility) in the future, or evendevelop symptoms (such as chromosomal disease) when changes in their chromosomes
occur. The frequency of these chromosomal changes is extremely rare (under 1%); there
are many people who spend their entire lives not knowing these chromosomal
abnormalities if they do not undergo medical testing or examinations.
On the other hand, there have been rare cases where the donor s chromosomal changes
were accidentally discovered through medical examination of the patient who underwent

Transportation fees

We will pay the actual transportation fees in each interview. Also, we will pay theactual transportation fees according to the method you have speciﬁed if you have to
visit the hospital, or get hospitalized for medical examinations, autologous blood

Ⅰ Cost burden of donors

if there are no symptoms in the person himself/herself, their children may inherit it and1collection, and G-CSF injections etc.
In principle, please kindly make use of public transport such as trains and buses. If
you have to take a taxi, please keep the receipt as we will ask for it.

2

Upfront paymenttransplantation using the donor s bone marrow or peripheral blood stem cells. Such

We will pay 5,000 yen of upfront payment when you are hospitalized in the CC/AC.

results allow donors to manage their health and think about how they can convey thisPlease understand that this is used to cover the cost of renting hospital gowns, andinformation to their own children. As this is information that one would not know withoutpurchasing towels, toothbrush, and prepaid TV cards.

undergoing medical examinations, there are also some donors who do not wish to knowsuch information. Therefore, if information pertaining to chromosomal abnormalities is
discovered, we will check with you through written ﬁnal consent in the interview whether
you would like us to disclose such information (you may answer this at a later date). If
you would like to know more about this, please ask your coordinating physician.

≪Examples of things where the cost will be not borne by the JMDP≫
Please understand in advance that the following costs cannot be borne by the JMDP.
◎Consultation fees of necessary medical examinations to conﬁrm your health before donation;◎Issuing fees for certiﬁcates such as identity veriﬁcation, and the transportation expenses required for these;◎Temporary absence from work compensation beneﬁt for medical examinations and hospitalization;◎Childcare expenses for your child during medical examinations and hospitalization, hotel fees for the family
members, car rental fees, pet hotel fees etc.;◎Expenses for the medical certiﬁcate necessary for donor s own paperwork;◎ Medical examinations and treatment fees etc. when the chronic illness (such as lower back pain, hernia)
deteriorates after donation, or when a symptom that is not caused by the harvest procedure occurs after
donation;◎Expenses such as private therapy that the donor opted for the symptoms that occurred after donation;◎Cost of living when work becomes diﬃcult due to symptoms after donation;◎ Treatment expenses etc. after being covered by disability insurance under the JMDP group accident
insurance;◎Other expenses that the JMDP has determined that it cannot take responsibility for.

50

51

3

Chapter 5

第5章◎ Should an accident happen to you from the donation of bone marrowor peripheral blood stem cells, we will make insurance payout of up to
100 million yen from the accident insurance to which the bone marrowbank has subscribed to.

3）The compensation contents are as follows.

Death beneﬁt

Permanent
disability beneﬁt

100 million
yen

3% -100% of theaforementioned◎ You will be eligible for insurance from the time you sign on the consent
form for conﬁrmatory typing (CT)s.
◎ You will not need to pay any insurance premium.

Hospitalization
beneﬁtExplanation
Donor

1

In the event that the donor is physically disabled within
180 days from the day of the accident, we will make3% to 100% of the amount of the death beneﬁt andpermanent disability beneﬁt depending on the extent
of injury.

When the donor is unable to return to his/her normal
work and/or maintain his/her normal lifestyle, andwhen the donor is hospitalized, we will make thepayment for hospitalization beneﬁt for the number ofdays that donor is hospitalized (up to 180 days fromthe day of the accident).
* We will only make the payment for hospitalization beneﬁt for
injuries due to peripheral blood stem cells harvest if you are
hospitalized for 4 days and more.

Various paperwork

JMDP

In the event that the donor passes away due toinjuries within 180 days from the day of the accident,
we will make the full payment of death beneﬁt andpermanent disability beneﬁt.

Ⅱ The JMDP Group Accident Insurance for Donor Compensation(up to 180 days)

10,000 yen
per day

Fees and Compensation

Ⅱ.The JMDP Group Accident
Insurance for Donor Compensation

Insurance company

Outline of the JMDP Group Accident Insurance for Donor Compensation1）It is an insurance which comprehensively compensates you from the time you leave yourHospital-visit
beneﬁt(90-day limit up to180th day)

5,000 yen
per dayhome to returning home for the purpose of donating bone marrow or peripheral blood
stem cells.
The insurance also covers injuries and accidents that occur on your trips to and from

When the donor has diﬃculty fulﬁlling his/her normal
work duties and/or maintaining his/her normal lifestyle,and when the donor has to visit the hospital (including
house visits) within 180 days including the day fromthe day of accident (*), we will make the payment for
the hospital-visit beneﬁt for the number of actual days
(up to 90 days) the donor visited the hospital.

* As most of the symptoms (such as headache, nausea, fever) from peripheral blood stem cells harvest are transient, the donor will only receive
payment if he/she visits the hospital and is hospitalized for 4 days or more since the start of receiving medical treatment.

the hospital. This is limited to 7 days since you left home for bone marrow donation, andlimited to 8 days since you left home for peripheral blood stem cells donation.
2）We will make insurance payout for accidents caused by bone marrow and/or
peripheral blood stem cells harvest, and related medical treatment.
Medical treatment related to the harvest procedure includes the following items.

4）When making insurance payout
If the donor has an accidental injury during the period described in point 5), we will
make the insurance payout (including injuries caused by bone marrow or peripheral
blood stem cells harvest, and from related medical treatment).
5）Period of making insurance payout◎After you have signed the Consent form for conﬁrmatory typing (CT)s , medical treatments suchas conﬁrmatory typing (CT) to determine your eligibility as a donor, health examinations before theharvest, autologous blood collection, and G-CSF injections.
◎Medical treatment such as physical examination after the harvest. However, this is limited to those
who visit a hospital within 3 months from the day after the day of bone marrow and/or peripheral
blood stem cells harvest.
◎Medical treatment (DLI) such as collecting blood for patients who did not completely recover after
transplantation. However, this is limited to procedures that were performed within two years fromthe day after the day of bone marrow and/or peripheral blood stem cells harvest.

The period is the earlier of any of the following points listed where the donor leaves
his/her home to undergo bone marrow or peripheral blood stem cells harvest surgicalprocedure and related medical treatment.
① When donor arrives back home
② At 12 p.m. on the 7th day counting from the day following the day the donor left
home (for bone marrow donation).
At 12 p.m. on the 8th day counting from the day following the day the donor left
home (for peripheral blood stem cells donation).

52

53

References

Insurance payout cannot be made for injuries caused by the following causes.

The JMDP has established a donor safety committee to analyze data on bone

○Suicide, physical ﬁghts, criminal acts
○Driving without a license, driving under the inﬂuence of alcohol

marrow harvest, and are reviewing ways to further improve the safety of donors.

○Earthquakes, volcanic eruptions, tsunami○War and other disturbances, nuclear reaction○Cerebral disorders, diseases, or loss of sanity not attributable to bone marrow or
peripheral blood stem cells harvest surgical procedure and related medical treatment○Surgical operation not attributable to bone marrow or peripheral blood stem cells
harvest surgical procedure and related medical treatment○Other medical measures1

Number of days of hospitalization of bone marrow donors(aggregated data from January 1993 to the end of March 2016)(No. of donors)

18,00015,267

16,00014,00012,00010,000Insurance payout cannot be made for the following injuries.

6,000
4,000

1,734

1,144

2,000

○Lumbago with only subjective symptoms

812
163

0
(Partially quoted from the special clause)
The Group Accident Insurance for bone marrow donors was revisedin November 1999 and implemented in December 1999.
The Group Accident Insurance for peripheral blood stem cells
donors was implemented in October 2010.

Ⅰ Bone marrow donation○Cervical compression syndrome with only subjective symptoms (also known as
whiplash injury )8,000

3 days4 days

5 days6 days7 days and more

（No. of days）

Approximately 30% of the 163 donors who were hospitalized for 7 days and more were out of the circumstances of theconvenience of the hospital that performed the harvests. Of the remaining 70%, 40% of them were hospitalized longer
than scheduled due to health reasons. In addition, 30% had to be hospitalized longer as the harvest procedures were
postponed.
There are 184 total cases of transplants from overseas donors to Japanese patients that are not included in the graph.

2【Number of responses: 13,084】from the questionnaire at the time of hospital discharge(aggregated data from February 2003 to the end of December 2015)◎Where is the site of pain?

2,886

ThroatUrination
pain

1,748

Intravenous
drip site

610 22102■ A little

335■ VeryAround the
buttocks

1,840

139

Site ofharvest10,288
0

2,000

4,000

6,000

607
8,000

This graph is constructed using data that can be aggregated.
* Due to multiple responses per donor, the number of responses and the total number do not match.

54

10,00012,000(No. of cases)

55

第6章

References

Ⅰ.Bone marrow donation

6）
When insurance payout cannot be made○Self-inﬂicted

Chapter 6

Chapter 6

Chapter 6

Number of days required to return to normal lifestyle4【Number of responses: 13,419】from the questionnaire sent 3 months after hospital discharge(aggregated data from January 1993 to the end of December 2015)(aggregated data from February 2003 to the end of December 2015)◎Is there any pain in the site of bone marrow harvest?

14,000(No. of donors)

13,902

12,000

References3■ 0.2％◎Were you worried about donating bone marrow?

■ 0.3％

The coordinator will check with you via phone to ask if■ 0.1％
■ 1％

■ 8％

■ 49％

your symptoms such as pain have disappeared or notafter you are discharged.

10,000This graph is constructed using data that can be
aggregated.

■ 50％

■ 91％

8,000

The day of harvest is Day 0 , and the graph indicates
how many days the donors resumed their normal
lifestyles after their hospital discharge.

6,000

Please use this graph as a rough guide as to thenumber of days you may require to resume your normal

4,000■ Fairly■ A little■Not at all■ None■ Others/no response■Very◎Did your family support your decision to donate bone marrow?

lifestyle after donating bone marrow.

■ 0.5％

991

303

90

0
1 to 7 days

8 to 14 days

15 to 21 days

◎If you were asked to donate bone marrow again, what would you do?
■ 0.3％■ 3％■ 51％

Ⅰ Bone marrow donation

■ 20％

2,000

■A little■Others/no response

■ 77％

■ 19％

■ 6％

136

22 to 29 days 30 days and more
(No. of days)■ 22％This graph is constructed using data that can be aggregated, and further classiﬁed into one-day units of 1 day to
7 days . * Due to diﬀerent aggregation periods, the total number of donors do not match that of the above graph.

■They have supported right from the start ■They supported midway

through ■They were against it ■They were not against it but did notsupport either ■They were not against it but did not support either

2,934

5

2,700

■I am not sure■I will not donate■Others/no response* Responses under 1% are displayed up to 1 decimal place(Aggregated data from January 2009 to the end of December 2015)

3,000（No. of donors）■I would donate

Drugs used during hospitalization(aggregated data from January 1993 to the end of March 2016)

2,400■ Antibiotics (to control inﬂammations etc.) 12,690 / 18,603 (68.2％）〔Used for a very short period〕

2,007

2,100
1,800
1,500

1,242

1,200

■ Pain killers (to relieve pain)

6,847 / 18,542 (36.9％）■ Iron preparations (to prevent anemia)

5,448 / 18,524 (29.4％）■ Fever medication (to bring down fever)

1,823 / 17,908 (10.2％）

900
692

563

600

353

300
82
0

1 day

2 day

3 day

4 day

5 day

6 day

7 day
(No. of days)* 5 is a summary of the report of when the donors were discharged from CC/AC. Please understand that there may be variations in the aggregated data.

56

57

Chapter 6

Symptoms and test results of day after the harvest(aggregated data from January 1993 to the end of March 2016)■ Fever of 38℃ and above・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・1,478 / 17,715 ( 8.3％)
Subsided within a day in most donors■ Urination pain・
・・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・2,068 / 14,801 (14.0％)
Pain and discomfort after catheter is removed from the urethra.
■ Abnormalities in site of harvest・・・・・・・・・・・・・・・・・・・・・・・・・・・・・214 / 18,763 ( 1.1％）
ncluding swelling, bleeding, and hematomas at site of needle puncture.
■ Infectious diseases・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・158 / 18,767 ( 0.8％）
Infections not at the site of needle puncture, but upper respiratory tract infections (cold) and urinary tract infections/■ Liver dysfunction・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・409 / 18,700 ( 2.2％）
Temporary■ Walking on the day after harvest

7 1. Complications associated with bone marrow harvest and anesthesia(aggregated data from January 1993 to the end of March 2016)

Amongst the complications associated with bone marrow harvest and anesthesia that were reported, 159 cases(as of end March 2016) were covered under the hospital-visit beneﬁt, and 38 cases were covered by to thepermanent disability beneﬁt of the JMDP group accident insurance.

■ Lowered blood pressure・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・4,507 / 18,770（24.0％）
Systolic pressure lowered to 80 mmHg or less during anesthesia. Temporary.
■ Blood in urine・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・169 / 14,669（ 1.2％)
Most of it is caused by irritation to the insertion of the urinary catheter. Most of such cases cannot beseen with the naked eye, and are temporary.
■ Arrhythmia (irregular pulse)・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・
・85 / 18,779（ 0.5％)
Temporary; symptom will improve.
■ •Denture damage, loose teeth・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・45 / 18,795（ 0.2％)
This happens when the tracheal tube is inserted or withdrawn from you during general anesthesia.
Please inform us in advance if you have dental implants.

■ Breakage of harvest needle・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・32 / 18,785（ 0.2％)
There have been cases when the harvest needle broke during the harvest procedure. There have also
been cases where an incision on the skin has to be made to retrieve the broken needle.
■ Laryngeal granuloma (1 case)This happens when a benign tumor forms in the larynx due to irritation from the insertion of the tracheal tube,
and was removed via surgery.
(There have been rare cases of a temporary change in voice due to the irritation from the tracheal tube.)■ Pain in lower left limb (1 case)
After the bone marrow harvest, donor began to experience numbness appeared from the left
femoral region to the knee, and pain in the harvest site for a long period. The donor resumed anormal lifestyle but the pain continued. The donor exhibited gradual improvements and thefollow-up process ended there.
■ Urinary tract injury (2 cases)
After the bone marrow harvest procedure was over, blood was observed in the site where theurinary catheter was removed. In addition to applying pressure to stop the bleeding, donors wereprescribed with complete bed rest, given painkillers, and their hospital discharge were postponed.
Coordinators follow-up with the donors until the symptoms improved.

■ Other complications
6 cases each:corneal erosion, lower back pain, femoral lateral cutaneous nerve palsy (left/right);
5 cases each:severe backpain in bone marrow puncture site, drug rash, pain and numbness infemoral region; 4 cases each:subcutaneous hematoma, pain at the harvest site (tenderness,pain), jaw arthritis (left/right), numbness in ﬁngers of right hand; 3 cases each:re-hospitalizationfrom worsening backpain, ulnar nerve palsy and desensitization (left/right), lower limb neuropathy
and peripheral neuropathy, severe pain in puncture site, numbness and pain in hands(left/right/both hands); 2 cases each:dura mater damage due to epidural anesthesia,
pyelonephritis, laryngeal granuloma (without surgery), slipped disk (lumbar), iliac puncture pain
(left/right), pneumonia (postoperative, accidental swallowing), lip erosion (upper lip/lower lip),sacroiliitis, diﬃculty walking due to lower backpain from the buttocks, brachial plexus paralysis(left/right), feeling of numbness in left hip, teeth damage, eyelid swelling in both eyes, mouth sores,
subconjunctival hemorrhage, lower backpain, pain from harvest site/hip to thighs; 1 caseeach:residual bone fragments, temporary deterioration of hearing diﬃculty, dermatitis at bonemarrow harvest site, bacteremia and septic sacroiliitis, prolonged phlebitis at intravenous injection
site, periostitis, thoracolumbar fascia pain, acute tonsillitis, bilateral iliopsoas hemorrhage,bronchopneumonia, lower backpain and numbness in lower right limb, traumatic sciatic nerve injury,meralgia paraesthetica in lower right limb, spondylosis, antibiotics anaphylaxis, meralgia
paraesthetica in left femoral region, pain in left femoral region and lower back, pelvic pain, lumbar
fasciitis, upper gastrointestinal bleeding, external laryngeal ulcers, poor swallowing, linear fracturesin the left iliac spine, folliculitis (mandibular), swelling at harvest site and fever, hematoma and iliac
inﬂammation after bone marrow harvest, viral esophagitis, penile erosion, nodules at the intravenous
injection site, numbness in right forearm radial side, myofascial pain, dental crown damage,periarthritis of shoulder, cubital tunnel syndrome, detached and/or fractured left iliac, lumbar(intervertebral) disk disorder, superﬁcial punctate keratitis, corneal epithelial defect in right eye,contact dermatitis from face to neck, discomfort in the left lateral knee, skin erosion at intravenous
injection site, urethral obstruction, persistent fever, subcutaneous hematoma due to leakage fromblood vessel during autologous blood collection, swelling of upper right lip, numbness in upper left
lip and upper lips, transient cheilitis after surgery, discomfort and pain in lower left limb, right sciatic
nerve pain, neuropathic pain at harvest site, superior cluneal nerve injury in left hip, paresthesia offront of right thigh, pain persistence and augmentation at puncture site, numbness in entire lower
right limb and left hip pain during walking, discomfort and persistent pain in left shoulder, internal
derangement of both knee joints, numbness and discomfort in knee, deep vein thrombosis, neckpain, pain and numbness at harvest site, left clavicular fracture (due to fall), pain from harvest site tothighs, hyperventilation attacks, pain in the median part of the right elbow, numbness in the left
lower limb, urethral injury, dull pain at puncture site, sensory mononeuropathy, complex regional
pain syndrome, pain in the posterior superior iliac spine, peripheral neuropathy in third toe,epidermolysis bullosa in both cheeks from compression, transient skin rash (due to anesthesia),
facial edema, right superior cluneal nerve injury, pain from right neck to shoulder, hip pain,
hematoma and internal bleeding after arterial puncture (DLI)Ⅰ Bone marrow donation

Unable to walk・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・103 / 18,471 ( 0.6％）
Able to walk a little・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・4,184 / 18,471 (22.7％）
No problems with walking・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・14,182 / 18,471 (76.8％）■ Deep vein thrombosis in lower right leg (1 case)
A blood clot was found in the deep vein of the lower right leg of the donor after the bone marrow
harvest procedure was over. The blood clot disappeared after the donor received medical
treatment.

References

6* All these symptoms are either cured or disappeared.
* There has only been 1 case of rheumatoid arthritis reported in the past; only a part of it was covered by the insurance because it was deemed that thedonor was predisposed to rheumatoid arthritis and that rheumatism could not have developed just from the bone marrow harvest procedure.

* 6 and 7 is summarized from the reports at the time of discharge from the CC/AC. Please understand that there may be variations in the aggregated data.

58

59

Chapter 6

In the cases in 7 -1, we have extracted a selection of complications that happened within a 5-year-period
between April 2011 to March 2016.

8 Health injuries in donors who donated to unrelated individuals (in order of occurrence)

References

7 2. Complications associated with bone marrow harvest and anesthesia

A case where donor developed acute hepatitis C
In March 1998, a donor who donated bone marrow to an unrelated individual developed acutehepatitis C after the bone marrow harvest procedure.

4 cases:
Pain and numbness in thigh, pain at harvest site (tenderness, pain)

3 cases each:Femoral lateral cutaneous nerve palsy (left/right), numbness and pain in hands (left/right)

2 cases each:dental crown damage, drug rash, feeling of numbness in ﬁngers of right hand, pain from harvest site/hip tothighs, lower backpain, lumbar pain, severe pain in bone marrow puncture site

1 case each:
Corneal erosion, swelling of upper right lip, eyelid swelling in both eyes, mouth sores, lip erosion (upper
lip/lower lip), numbness in upper left lip and upper lips, transient cheilitis after surgery, jaw arthritis(left/right), pain from right neck to shoulder, persistent fever, hyperventilation attacks, transient skin rash

CourseAbout 2 weeks after donating bone marrow, the donor developed acute hepatitis C and was re-hospitalized
for treatment, to which the donor recovered. The donor returned to work and resumed a normal lifestyle.
Investigation on the cause of this onset indicated that the donor may have been infected during the bonemarrow harvest procedure. However, it was not possible to identify the medical procedure that left to theinfection.

Countermeasure
The JMDP has notiﬁed harvest facilities across Japan the preventive measures for similar cases as follows.
① Recommends the use of disposable bone marrow harvest needles② To comply with the autologous blood management manual that describes the collection, storage, andtransfusion procedures of blood for autologous blood transfusion, and has notes on how to handle
contaminated blood

Ⅰ Bone marrow donation(due to anesthesia), subcutaneous hematoma due to leakage from blood vessel during autologous bloodcollection, pain in the median part of the right elbow, discomfort and pain in left shoulder, left clavicular
fracture (due to fall), sacroiliitis, severe puncture pain (left/right), swelling at harvest site and fever, pain
and numbness at harvest site, dull pain at puncture site, hip pain, hematoma between left gluteal muscles,
right superior cluneal nerve injury, neuropathic pain at harvest site, right sciatic nerve pain, superior
cluneal nerve injury in left hip, feeling of numbness in left hip, urethral obstruction, urethral injury, feelingof numbness from left hip to foot, numbness in entire lower right limb and left hip pain during walking,paresthesia of front of right thigh, discomfort and pain in lower left limb, numbness in lower left limb,
internal derangement of both knee joints, numbness and discomfort in knees, lower limb neuropathy andperipheral neuropathy, deep vein thrombosis in lower limbs, walking diﬃculty, sensory mononeuropathy,
complex regional pain syndrome, pain in the posterior superior iliac spine, peripheral neuropathy in third
toe, hematoma and internal bleeding after arterial puncture (DLI).
* All these symptoms are either cured or disappeared.
* There has only been 1 case of rheumatoid arthritis reported in the past; only a part of it was covered by the insurance because it was deemed that the donor was
predisposed to rheumatoid arthritis and that rheumatism could not have developed just from the bone marrow harvest procedure.

A case where a retroperitoneal hematoma was observed in the donor after
the bone marrow harvest procedure
In September 2000, a considerable large hematoma was found in a donor who donated bonemarrow to an unrelated individual.

CourseAfter the bone marrow harvest procedure, the donor complained of lower abdominal pain and underwent
medical examinations such as CT scan that conﬁrmed the presence of a hematoma at the retroperitoneum(there was a bleeding blood clot situated between the peritoneum and the abdominal wall). The donor shemoglobin levels decreased to 6.7 g/dL (12.3 g/dL before donating bone marrow) for a short while. The
donor soon recovered from anemia without transfusion and returned to society.

Countermeasure
TThe JMDP has issued an emergency safety information on warnings on the site and depth of bonemarrow puncture to all harvest facilities across Japan. The accident investigation committee conducted aninvestigation and reviewed measures to prevent similar reoccurrences. They came to the conclusion thatwhile there was a high possibility that the harvest needle had damaged the blood vessels inside the ilium, it
was not possible to identify the actual site where bleeding occurred and the cause of bleeding.

A case where the donor had persistent lower backpain over a long period oftime after the bone marrow harvest procedure
In March 2003, a donor complained of prolonged pain in the lower back for a long period of timeafter the donor donated bone marrow to an unrelated individual.

CourseAfter the donor was discharged from the hospital when the bone marrow harvest procedure was over, he
underwent MRI examinations for persistent pain. Results showed that there were incomplete fractures in thebilateral iliac bones and bone marrow edema. The donor was thus re-hospitalized again for another week
and the pain subsided 8 months later.

Countermeasure
The JMDP conducted an investigation to determine the cause and to prevent such reoccurrences. Resultsof the investigation indicated that the following 2 points might have been the reasons as to why thedonor s pain at the harvest site had persisted for a long period of time.

60

61

Chapter 6

A case where donor was suspected of pulmonary fat embolism after the bonemarrow harvest procedure
In August 2003, the donor was found to have decreased oxygen saturation levels after the donor donatedbone marrow to an unrelated individual.

CourseAfter the oxygen saturation levels in the arterial blood was observed, the donor underwent lung CT scans to which
pulmonary fat embolism was suspected.
The donor was immediately put on oxygen inhalation and given treatment with steroid hormones, to which thedonor s respiratory condition improved the following day. The donor soon returned to society.

Countermeasure

A case where a hematoma was found in the left iliopsoas region after thebone marrow harvest procedure
In October 2009, a hematoma was found in the left iliopsoas region of the donor after donatingbone marrow to an unrelated individual.

CourseTwo hours after the bone marrow harvest procedure, the donor complained of abdominal pain in the left
inguinal region and was prescribed with painkillers. However, the pain did not subside and a CT scan was
performed on the donor. Results of the CT scan conﬁrmed pelvic hemorrhage and angiography was
performed on the donor. Embolization was immediately performed on the artery that was thought to be theblood vessel responsible for bleeding using Spongel, and the donor was put under observation andprescribed with painkillers and complete bed rest. The donor s hemoglobin level was reduced to 9.4 g/dL
at one time (13.2 g/dL before donating bone marrow).

Countermeasure
The JMDP has issued an emergency safety information on warnings on the length of the puncture needle
and the thickness of the ilium, and depth of bone marrow puncture to all harvest facilities across Japan.
The JMDP also conducted an investigation to determine the cause and to prevent such reoccurrences.
Results of the investigation indicated that the cause of the hematoma was likely to be due to thepenetration of the harvest needle, and recognized that there are individual diﬀerences in the shape of thepelvis. The JMDP also issued a safety information to harvest facilities to take into account the donor s
BMI etc., and to choose the shortest possible bone marrow harvest needle.

Ⅰ Bone marrow donation

The JMDP issued an emergency safety information to all harvest facilities across Japan. While the JMDP also
conducted an investigation to determine the cause and to prevent such reoccurrences, no speciﬁc cause could befound.
As a countermeasure, the JMDP issued a safety information where in the event that oxygen saturation levels arefound to be persistently decreased after the bone marrow harvest procedure, the donor in question is to undergo
medical examinations including chest X-P examinations, lung CT scans, MRI, lung scintillation imaging, andvascular ultrasound.
In addition, the JMDP notiﬁed the harvest facilities to look into the bronchoalveolar lavage in order to ensure
safety.

References① Presence of incomplete fractures which is thought to be evidenced by the image of the irregular cortical bone
and image of discontinuity of the cortex observed through the CT scans② Possibility of hematoma due to hemostasis after harvest
The JMDP has issued a safety information where donors can promptly report to the authorities when pain
persists for more than a month, or when they have taken painkillers continuously for a week or more.

A case where a hematoma was found in the left gluteus medius after thebone marrow harvest procedure
In March 2015, a hematoma was found in the left gluteus medius of the donor after donating bonemarrow to an unrelated individual.

CourseA case where a hematoma was found in the left ilio-lumbar region after the bonemarrow harvest procedure
In August 2003, a hematoma was found in the left ilio-lumbar region of the donor after donating bonemarrow to an unrelated individual.

CourseOn the following day after the bone marrow harvest procedure, the donor complained of tenderness in the left
lower abdomen, and was thus subjected to medical examinations such as CT scan to which a hematoma and gas
were found in the left iliopsoas.
Donor was put on hemostatic agents and antibiotics and the donor s hemoglobin level was reduced to 12.8 g/dL
at one time (16.1 g/dL before donating bone marrow).
While the donor had tenderness in the left lower abdomen, the donor could walk and overall physical condition
such as appetite was good.
The donor soon recovered and returned to society.

Countermeasure
The JMDP has issued an emergency safety information on warnings on the site and depth of bone marrow
puncture to all harvest facilities across Japan.
While the JMDP also conducted an investigation to determine the cause and to prevent such reoccurrences.
Results of the investigation indicated that the cause of the hematoma was likely to be due to the penetration of
the harvest needle. The JMDP issued a safety information to harvest facilities to adjust the depth of thepuncture.

62

The donor was discharged 2 days after the bone marrow harvest procedure but was admitted into the A&E
when the pain at the harvest site became more severe on day 4 after harvest, and when swelling in the left
buttock, pain deterioration, and numbness of thighs appeared on day 5.
CT scans revealed pseudoaneurysm in the superior gluteal artery and bleeding in the gluteus medius. Dueto the progression of anemic symptoms, arterial embolization was subsequently performed on the third dayof hospitalization, to which the symptoms of anemia improved and the donor s general condition stabilized.
The donor soon recovered and returned to society without any pain and the numbness.

Countermeasure
The JMDP has issued an emergency safety information to all accredited harvest facilities for bone marrow
harvest between unrelated individuals and called their attention to this case. The JMDP also conducted aninvestigation to determine the cause and to prevent such reoccurrences.
Results of the investigation indicated that harvest facilities are to pay attention to the puncture site andpuncture depth, to feel the site after puncturing, and to always puncture the needle perpendicular to thesurface of the bone in bone marrow harvest procedures, and that the bone marrow harvest needle shouldbe 3 inches and shorter in principle (2 inches and shorter is preferable). The JMDP also issued a safety
information that prohibits the use of the bone marrow harvest needles longer than 3 inches.

63

3Chapter 6

Cases covered by the permanent disability beneﬁt⑲ Peripheral neuropathy in left hip
Donor experienced persistent numbness from left hip region to toes after the harvest procedure was over.

References

9⑳ Peripheral neuropathy in right femoral region
Donor experienced paresthesia in anterior and lateral right femoral region after the harvest procedure was over.

As of end March 2016, the permanent disability beneﬁt covered the following 38 cases.
① Ulnar neuropathy in left hand
The ulnar neuropathy was assumed to be caused by ulnar nerve compression during the bone marrow harvest procedure,
to which paresthesia remained in the ulnar in the left hand (4th and 5th ﬁngers).
② Transient hemiplegia and residual, mild decrease in sensation
The donor suﬀered from transient hemiplegia on the left side after waking up from general anesthesia. The donor
recovered quickly without medication, was discharged and resumed a normal lifestyle. However, the donor had residual,
mild hypoesthesia and numbness in the ulnar in the left hand (part where the little ﬁnger joins the palm).
③ Mononeuropathy of the lateral femoral cutaneous nerve
Mononeuropathy of the lateral femoral cutaneous nerve occurred in the donor after the harvest procedure was over.
While the donor had no diﬃculties in his/her everyday life, there was residual numbness in the right inguinal region.

㉑ Peripheral neuropathy with neuropathic pain
Donor experienced persistent pain in right hip region and numbness in lower right limb after the harvest
procedure was over.
㉒ Lower backpain and lower backpain with internal derangement of both knee joints
Donor experienced persistent lower backpain after the harvest procedure was over and was diagnosed withlumbago. As donor tried to walk with lower backpain, donor experienced pain in both knees and was
subsequently diagnosed with internal derangement of both knee joints with persistent pain.
㉓ Numbness in the left lateral femoral cutaneous nerve region
Donor experienced persistent numbness in the left lateral femoral cutaneous nerve region after the harvest
procedure was over.
㉔ Persistent discomfort and pain in left shoulder
Donor experienced persistent discomfort and pain in left shoulder after the harvest procedure was over.
㉕ Numbness and discomfort from left hip joint to left femoral region and knee
Donor experienced persistent numbness from left hip joint to left femoral region and knee after the harvest
procedure was over, and was diagnosed with left meralgia paresthetica.

⑤ Postoperative causalgia in hips
Donor had persistent lower backpain for a long period of time after the harvest procedure was over. Residual pain in thesite of bone marrow harvest (hips).

㉖ Numbness in left hip region
Donor experienced persistent numbness from left inguinal region to left hip region after the harvest procedure
was over.

⑥ Reﬂective sympathetic dystrophy
Donor experienced residual pain and numbness from around the left hip to the left femoral region after the harvest
procedure was over.

㉗ Pain in puncture site and lower backpain
Donor experienced persistent pain in puncture site and lower backpain after the harvest procedure was over.

⑦ Traumatic sciatic neuropathy
Donor experienced residual pain in lower left limb and numbness after the harvest procedure was over.

㉘ Rheumatoid arthritis
Donor experienced neuropathic symptoms (joint, swelling, as well as decreased grip strengths in both hands)
with rheumatoid arthritis after the harvest procedure was over.

⑧ Sacroiliitis
Donor experienced sacroiliitis and residual pain after the harvest procedure was over.

㉙ Sacroiliitis
Donor experienced persistent pain in lower left limb and lower backpain after the harvest procedure was over.

⑨ Left lateral femoral cutaneous nerve disorder
Donor experienced numbness and sensory disorders such as tactile sensation in the left thigh and deﬁcit of thermal
sensation after the harvest procedure was over.
While the numbness disappeared afterwards, paresthesia remained.

㉚ Numbness and pain in both hands
Donor experienced persistent pain and numbness in both hands (4th and 5th ﬁngers in both left and right hand
respectively) after the harvest procedure was over.

⑩ Postoperative causalgia in hips
Donor had persistent pain from left hip region to buttock for a long period of time after the harvest procedure was over.
Residual pain in the left hip region.
⑪ Right lateral femoral cutaneous nerve disorder
Donor experienced numbness and sensory disorders such as tactile sensation in the right thigh and deﬁcit of thermal
sensation after the harvest procedure was over.
While the numbness disappeared afterwards, paresthesia remained.
⑫ Slipped disk, cervical spinal canal stenosis
Slipped disk and cervical spinal canal stenosis became more apparent in the donor after the harvest procedure was over.
Residual symptoms such as numbness in the left femoral region, inability to raise both arms vertically, and Gower s sign.
⑬ Lower backpain in bone marrow puncture site in right iliac
Donor experienced pain in the bone marrow puncture site and persistent decreased in sensation in the lower right limb.
⑭ Left sacroiliac joint refractory pain
Donor experienced numbness from left hip to buttock and persistent dull pain after the harvest procedure was over.
⑮ Bone pain after bone marrow harvest procedure
Donor experienced persistent pain in the bone marrow harvest site due to increased bone formation after the harvest
procedure was over.
⑯ Lumbar radiculopathy
Donor developed lumbar radiculopathy after the harvest procedure was over, and had persistent lower backpain andparesthesia.
⑰ Lumbar radiculopathy and left ulnar neuropathy
Donor developed lumbar radiculopathy after the harvest procedure was over, and had persistent lower backpain andparesthesia. Donor also suﬀered an injury on the left ulnar nerve that led to paresthesia in the ulnar in the left hand (5thﬁnger)Ⅰ Bone marrow donation④ Decreased sensation in right buttock region
Decreased sensation in right buttock region occurred in the donor after the harvest procedure was over. While the donor
had no diﬃculties in his/her everyday life, the decreased sensation did not disappear.

㉛ Persistent pain from harvest site to femoral region
Donor experienced persistent pain from harvest site to femoral region after the harvest procedure was over.
㉜ Cutaneous gluteal neuropathy
Donor experienced persistent numbness and pain in the superior cluneal nerve injury in left hip after the harvest
procedure was over.
㉝ Pain in femoral region and numbness in lower limbs
Donor experienced persistent pain in femoral region and numbness in lower limbs after the harvest procedure wasover.
㉞ Pain in right posterior superior iliac spine as well as pain and numbness in right lateral femoral region
Donor experienced persistent pain in right posterior superior iliac spine as well as pain and numbness in rightlateral femoral region after the harvest procedure was over.
㉟ Prolonged pain in bilateral pelvic puncture site
Donor experienced persistent pain in bilateral pelvic puncture site after the harvest procedure was over.
㊱ Tenderness at harvest site and pain during movement
Donor experienced persistent tenderness in bilateral posterior iliac crest (harvest site) as well as pain during
movement after the harvest procedure was over.
㊲ Lumbago
The lumbar disc disorder may have become more apparent and donor experienced persistent dull pain in lower
back after the harvest procedure was over.
㊳ Right superior cluneal nerve injury
Donor experienced persistent pain in right gluteal region after the harvest procedure was over.
* For more details on the cases covered by the permanent disability beneﬁt, please visit the JMDP homepage.

⑱ Lumbar (intervertebral) disk disorder
Donor was diagnosed with lumbar (intervertebral) disk disorder after the harvest procedure was over, and experienced
discomfort in hip region and persistent numbness in toes.

64

65

Ⅱ.Peripheral blood stem cells donation

References(covered between 1995 to the end of March 2016)

１：Hospital-visit beneﬁt

A. Peripheral blood stem cells harvest
between unrelated individuals

16(No. of cases)

14(aggregated data from March 2011 to the end of September 2016)
12

Between March 2011 to the end of September 2016, the JMDP has helped incoordinating 225 cases of peripheral blood stem cells harvest procedures

10

implemented between unrelated individuals. We analyzed the data and are currently
looking into ways to further improve the safety of donors.

8

No. of days of G-CSF administration, and harvest［No. of responses: 225］

Ⅱ Peripheral blood stem cells donation

1
6(aggregated data from March 2011 to the end of September 2016)◎No. of days of G-CSF administration◎No. of days of harvest4■ 2 cases 1％

2■ 11 cases 5％■ 33 cases

15％■ 67 cases

30％

95 996 997 998 999 000 001 002 003 004 005 006 007 008 009 010 011 012 013 014 015
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
1
1
1
1

19

(Year)■ 145 cases* Please visit the JMDP homepage for the list of cases covered by the JMDP Group Accident Insurance .

■ 3 days

２：Permanent disability beneﬁt
7

2(No. of cases)6■ 4 days■ 5 days85％■ 6 days■ 1 day■ 1 day

Hospitalization period of peripheral blood stem cells donors［No. of responses: 225］
(aggregated data from March 2011 to the end of September 2016)5◎Hospitalization period■ 1 cases 0％4■ 2 cases 1％■ 18 cases

3

8％

2
1

■ 3 cases 1％■ 20 cases 9％■ 13 cases

6％■ 83 cases

37％

0
7

9
19

8

9
19

9

9
19

0

0
20

1

0
20

2

0
20

3

0
20

4

0
20

5

0
20

6

0
20

7

0
20

8

0
20

9

0
20

0

1
20

1

1
20

2

1
20

3

1
20

4

1
20

* There were no applications by bone marrow donors for the permanent disability beneﬁt between 1995 to 1996.

66■ 192 cases64％■ 85 cases

38％(Year)■ 2 days 1 night■ 3 days 2 nights ■ 4 days 3 nights ■ 5 days 4 nights■ 6 days 5 nights ■ 7 days 6 nights ■ 8 days 7 nights ■ 9 days 8 nights

67

第6章

Chapter 6

10 Number of yearly bone marrow harvest cases covered by the JMDP Group Accident Insurance

4

Based on questionnaire sent 3 months after hospital discharge［No. of responses: 124］
(aggregated data from March 2011 to the end of September 2016)(aggregated data from March 2011 to the end of September 2016)■Subjective, physical ﬁndings◎Do you experience any pain in the site where peripheral
blood stem cells were harvested from?

Day 3 after G-CSF injection

Day of harvest

During hospital discharge

After hospital discharge

Mild Moderate Serious Severe

Mild Moderate Serious Severe

Mild Moderate Serious Severe

Mild Moderate Serious Severe

Fever

19

10

10

Fatigue

39

2

Insomnia

16

4

Dizziness

1

2

Loss ofappetite

4

3

Nausea

2

1

1
2

37

2

20

23

5

8

4

5

2

4

1

4

3

1

3

3

Reactions on
injection site

Splenomegaly0％■ 92cases■ 28cases74％■ 62cases■ 62cases

50％

50％

3

1
■Light■Normal■Severe■Not at all■A little■Extremely

2
1

3

5

3

3

2

1

1

3

5

6

■ 0case3％

1◎Did your family approve of your decision to donate
peripheral blood stem cells?

■ 20cases◎If you were asked to donate bone marrow again, what would you do?

■ 24cases

16％

3

Ⅱ Peripheral blood stem cells donation

1

Vomiting
Skin rash

1◎Were you worried about donating peripheral blood stem cells?

■ 4cases

23％

33

References

Status of adverse eﬀects, and development of complications［No. of responses: 225］

19％

■ 97cases■ 98cases78％■ 7cases79％■ 2cases

6％

2％

■Pain
Day 3 after G-CSF injection

Day of harvest

During hospital discharge

After hospital discharge

Mild Moderate Serious Severe

Mild Moderate Serious Severe

Mild Moderate Serious Severe

Mild Moderate Serious Severe

38

4

27

3

13

4

Bone pain 40

5

44

5

Headache 30

1

22

4

■Yes

Back

Lower
backpain68

123 10

Puncture site

2

Joints

17

Arms

4

Limbs

4

Muscles12

Neck
Throat1

102 14
6

1

1

1

16

2

14

1

■No

■Neither■I would donate■I am not sure

◎Resuming normal lifestyle 【No. of total responses: 103】

3

2

59

5

5

1

8

2

5

1

21

2

6

2

2

1

1

1

6

2

1

1

1

4

1

2

1

11

3

8

11

7

1

4

4

1

■ 5cases 5％21■ 1case 1％■ 4cases 4％■ 19cases18％■ 9cases9％■ 22cases■ 43cases

21％

42％

1
1

■I will not donate* Base date = discharge date

■1 day■2 days ■3 days ■4 days

■6 days ■8 days ■11 days

2

3

69

第6章

Chapter 6

3

The JMDP has coordinated a total of 225 cases of peripheral blood stem cells donations
between unrelated individuals from March 2011 to the end of September 2016. We havealso published data on donations between blood relatives * for your reference.
* The Japan Society for Hematopoietic Stem Cell Transplantation has conducted medical examinations and questionnaires once a year for 5 years asa Follow-up project on allogeneic peripheral blood stem cells donors on donors who provided peripheral blood stem cells for blood relatives during
2000-2005 (ended in 2010). The following 1 to 4 are analyzed data based on cases obtained through this project.

http://www.jshct.com/index.shtml

1

Relatively short-term severe health abnormalities①Probably temporary due to G-CSF injection
Symptoms

No. ofdonors9/3264 donors = 0.28%

Calculated from the day of ﬁrst injection of G-CSF
Day of onset

Day of disappearance

Abnormalities in liver function

8

Days 3 to 10

Days 11 to 36

Loss of appetite, nausea, vomiting

1

Day 4

Day 19②Probably temporary due to harvest procedure
Symptoms

No. ofdonors19/3264 donors = 0.58%

Calculated from the day of ﬁrst injection of G-CSF
Day of onset

Day of disappearance

Thrombocytopenia

13

Days 2 to 6

Days 8 to 111

Vasovagal reﬂex

2

Day 4

Days 4 to 5

Tetany

1

Day 4

Day 6

Paresthesia in limbs

1

Day 4

Day 6

Hematoma in puncture site

1

Day 7

Day 13

70

1

Day 9

Day 10Day of onset

Day of disappearance

Heart attack

4

Days 2 to 4

Days 4 to 6

Deep vein thrombosis

1

Day 14̶Peritoneal ﬂuid, pericardial eﬀusion, systemic edema

1

Day 7

Day 9

Blood in phlegm

1

Day 3

Day 5

Subarachnoid hematoma (operation)1

Day 23

Day 48Retroperitoneal hematoma/anemia (operation)

1

Day 4

Day 25

Hemorrhagic stomach ulcer

1

Day 8

Day 16

Interstitial pneumonia

2Days 3 to 25

Days 6 to 70

Gout attack/ acute cholecystitis (operation)

1

Day 2

Day 19Fever or infection

5

Days 2 to 7

Days 12 to 32

Slipped disk

1

Day 7

Day 62* There have been 25/5921 cases of short-term clearly severe health abnormalities reported in bone marrow donors, and thisstatistic is not signiﬁcantly diﬀerent from that of in peripheral blood stem cells donors (based on a joint survey conducted by theJapan Society for Hematopoietic Stem Cell Transplantation and Ministry of Health, Labour and Welfare Scientiﬁc Research Unit)

2 Other non-severe health abnormalities where the causal relationship with G-CSF
injection and harvest procedure cannot be denied that appeared within 30 days

Vomiting

98％

1％ 1％

Nausea94％

5％ 1％

Loss of appetite

91％

Insomnia

Migraines

Calculated from the day of ﬁrst injection of G-CSF

No. ofdonorsⅡ Peripheral blood stem cells donation

Other than the aforementioned Follow-up project on allogeneic peripheral blood stem cells donors , theJapan Society for Hematopoietic Stem Cell Transplantation is also following up on donors who donated bone marrow
as well as peripheral blood stem cells for blood relatives since 2005 ( Follow-up project on blood hematopoietic
stem cells donors ). The cases in this project will not be reported as they are still currently under study, but you canrefer to the website of the Japan Society for Hematopoietic Stem Cell Transplantation for more details.

References(aggregated data from 2000 to 2005)

Symptoms* Causal relationship with G-CSF not yet established.

6％

84％

Headaches

13％

77％

Malaise

3％

19％

71％

24％

3％

4％

5％

■ NoneBone pain

35％

49％

16％

■ Mild■ Moderate

71

第6章

Chapter 6

B. Peripheral blood stem cells harvest
between related individuals③ Clearly severe 19/3264 donors = 0.58%

MEMO
3

Health conditions of donors from annual medical examinations(6233 reports obtained from 1708 donors in a maximum period of 5 years)

No health abnormalities

Health abnormalities present* Only the main abnormality is stated when there are multiple abnormalities in any one donor

485/1708donors（28.4％）
A.Abnormalities present even before donation：109（6.4％）

1223 /1708（71.6％）

B.Abnormalities that appeared after donation, and thought to be temporary or due to lifestyle(colds, traﬃc accidents, pregnancies, high blood pressure, diabetes, surgeries etc.)：133（7.8％）
C.Abnormalities that appeared after donation but not listed in B:C-1）Non-neoplastic, non-severe：204（11.9％）
C-2)Non-neoplastic, severe：26（1.5％） C-3)Tumors other than blood：12（0.7％）
C-4）Hematological tumor：1（0.06％）* The (%) is a ratio of the total number of 1708 donors

4 Relatively long-term, severe health abnormalities where the causal relationship withthe peripheral blood stem cells harvest procedure is unclear and cannot be denied
SymptomsC-2) Non-neoplastic,
severe: 26 donors

C-3) Non-hematologicaltumors: 12 donors

C-4) Hematologicaltumors: 1 donor

No. ofdonorsMonth of onset after donation

Abnormal thyroid function

7

10 to 34 months later

Uterine ﬁbroid3

14 to 36 months later

Chronic rheumatoid arthritis

2

20 to 23 months later

Cerebral infarction

2

7 to 33 months later

Subarachnoid hematoma

1

9 months later

Cataracts

1

7 months later

Fundus hemorrhage

1

33 months later

Atopic dermatitis

1

12 months later

Uveitis1

20 months later

Bronchial asthma

1

20 months later

Endometriosis

1

20 months later

Idiopathic thrombocytopenic purpura

1

27 months later

Molar pregnancy

1

9 months later

Cerebral aneurysm

1

24 months later

Pancreatic cystic tumor

1

49 months later

IgA nephropathy

1

44 months later

Breast cancer

6

4 to 43 months later

Stomach cancer

1

23 months later

Uterine cancer

1

10 months later

Brain tumor

1

6 months later

Pharyngeal cancer

1

13 months later

Lung cancer

1

54 months later

Prostate cancer

1

55 months later

Acute myelogenous leukemia

1

14 months later* There is another case where a donor with pre-existing myeloproliferative disorder developed leukemia 48 months later.

72

73

Reference Information◎There are insurance products that will may insurance payouts for hospitalization for bonemarrow donations. Please contact the insurance company you would like to buy the
product from for more details.
◎There are local governments that have introduced a subsidy system for donors.
Please refer to the JMDP website for more information on the local governments.
http://www.jmdp.or.jp/donation/about/post̲202.html

HANDBOOKFor Donors

1st edition issued on October 1, 2013
2nd edition issued on August 1, 2014
3 rd edition issued on December 1, 2015
4 th edition issued on February 1, 2017
Edited by: Japan Marrow Donor Program(Public Interest Incorporated Foundation)
Issued by: Japan Marrow Donor Program(Public Interest Incorporated Foundation)
Hirose 2nd Bldg., 7th Floor,
3-19 Kandanishiki-cho,
Chiyoda, Tokyo 101-0054, JAPANTEL 03-5280-2200 (direct line to Donor Coordination Department)
FAX 03-5283-5629 (same as above)
JMDP Website

http://www.jmdp.or.jp