I 

108TH CONGRESS 

1ST SESSION H. R. 2852

To amend the Public Health Service Act to establish a National Cord Blood 

Stem Cell Bank Network to prepare, store, and distribute human umbilical cord blood stem cells for the treatment of patients and to support 

peer-reviewed research using such cells. 

IN THE HOUSE OF REPRESENTATIVES 

JULY 24, 2003

Mr. SMITH of New Jersey (for himself, Mr. BURR, Mr. DAVIS of Alabama, 

Mr. TOWNS, Mr. DOOLITTLE, Mr. TOOMEY, Mr. FALEOMAVAEGA, Mr. 

WELDON of Florida, and Mrs. MYRICK) introduced the following bill; 

which was referred to the Committee on Energy and Commerce 

A BILL

To amend the Public Health Service Act to establish a National Cord Blood Stem Cell Bank Network to prepare, 

store, and distribute human umbilical cord blood stem 

cells for the treatment of patients and to support peerreviewed research using such cells.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Cord Blood Stem Cell 

5 Act of 2003’’ . 
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1 SEC. 2. FINDINGS. 

2 The Congress makes the following findings: 

3 (1) Research sponsored by the National Insti4 tutes of Health and conducted in full compliance 

5 with applicable Food and Drug Administration regu6 lations has demonstrated the feasibility of using cord 

7 blood for clinical applications. Stem cells, obtained 

8 from the blood contained in the delivered placenta 

9 and umbilical cord and donated by the mother, can 

10 be used for bone marrow reconstitution by trans11 plantation to recipients with certain malignancies 

12 (such as leukemia and lymphoma), genetic disorders 

13 (such as sickle cell anemia), and acquired diseases. 

14 (2) The placenta, umbilical cord, and the neo15 natal blood they contain are normally discarded 

16 after childbirth. This residual neonatal blood, termed 

17 cord blood, is a source of stem cells that can be col18 lected as donor tissue without risk to the donor and 

19 can be preserved through freezing for many years 

20 and be made immediately available for transplan21 tation in routine or emergency clinical situations. It 

22 can also be used for scientific research involving its 

23 stem cells. 

24 (3) Advantages of cord blood stem cell trans25 plants relative to bone marrow transplants include 

26 the reduction of risks to the donor, availability of 
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1 donor cell units in days rather than months, and 

2 lower risk of transplant complications, including 

3 graft versus host disease and latent virus infections 

4 (such as Epstein-Barr virus or Cytomegalovirus). 

5 (4) In conventional bone marrow transplan6 tation, matched siblings are the preferred donors, 

7 but only 30 percent of patients have a matched sib8 ling. When no sibling match is found, a search is ini9 tiated for an unrelated donor. 

10 (5) Finding a fully matched unrelated donor op11 timizes the chances of successful bone marrow trans12 plantation. In conventional bone marrow transplan13 tation, patients of ethnic minorities generally have 

14 difficulty finding fully matched donors, leaving par15 tially matched transplants as their only transplant 

16 option. Partially matched bone marrow transplan17 tation leads to a disproportionately high rate of com18 plications, including graft versus host disease and 

19 mortality. 

20 (6) Cord blood stem cell banks would provide 

21 increased genetic diversity in the supply of donors 

22 and increase the opportunity to identify fully 

23 matched and partially matched transplant units for 

24 qualified candidates. Cord blood stem cell trans25 plants using partially matched units reduce the risk 
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1 of graft versus host disease with its attending mor2 bidity and mortality as compared to conventional 

3 bone marrow transplantation. 

4 (7) Identifying and delivering an unrelated bone 

5 marrow donor from among the several millions in 

6 the National registry typically requires many 

7 months, sometimes more than 1 year. An inventory 

8 of 150,000 cord blood stem cell units, that takes 

9 into account the ethnic diversity of the country, 

10 would help provide appropriate matches for at least 

11 90 percent of those seeking matched cord blood stem 

12 cell transplants, within days of a formal request. 

13 (8) Matched donors are more likely within the 

14 same ethnic group as the patient’s. Some genetic 

15 conditions are also more prevalent in members of 

16 particular ethnic groups, such as Sickle Cell Anemia, 

17 a disease that occurs in one out of 500 African18 American newborns. From early infancy, patients 

19 with Sickle Cell Anemia have a high risk of severe 

20 or fatal bacterial blood infections. Many patients de21 velop painful crises beginning in infancy and occur22 ring up to 20 times per year. Children with recur23 rent crises, chest syndrome or strokes, are at great 

24 risk of dying before the age of 20 years. The median 

25 life-span of a patient with Sickle Cell Disease is 42 
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1 years, but patients with severe disease in childhood 

2 rarely live beyond 20 years. Cord blood stem cell 

3 transplantation has cured patients with Sickle Cell 

4 Anemia: 80 percent of children transplanted with re5 lated cord blood to correct Sickle Cell Anemia or 

6 thalassemia were cured in a recently published 

7 study. The earlier in the course of severe disease, 

8 the transplant is performed, the better the outcomes. 

9 Unrelated cord blood transplants are especially bene10 ficial for African American and other ethnic minor11 ity patients because cord blood does not have to 

12 match as closely as bone marrow. For this reason, 

13 an African American patient is much more likely to 

14 find a suitable unrelated cord blood donor as com15 pared to a matched bone marrow donor. With an 

16 ethnically balanced national cord blood bank of at 

17 least 150,000 units, some 90 percent of African 

18 American patients who suffer from Sickle Cell Ane19 mia or other conditions requiring bone marrow re20 placement would be able to find appropriately 

21 matched cord blood stem cells for successful treat22 ment. 

23 (9) Since its inception in 1987, the National 

24 Marrow Donor Program has facilitated 17,000 bone 

25 marrow transplants. Cord blood transplantation 
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1 complements conventional bone marrow transplan2 tation by providing appropriately matched units to 

3 patients, especially those of non-caucasoid ethnicity, 

4 who have a much lower probability of finding an 

5 adequate match through the National Marrow Donor 

6 Program. Cord blood is one of the sources of stem 

7 cells used in transplantation, however, its collection, 

8 preparation, storage and dissemination require spe9 cific systems and expertise. 

10 (10) Radiation exposure, from accidents or hos11 tile actions could cause bone marrow failure in a 

12 portion of those exposed, requiring treatment includ13 ing bone marrow reconstitution. In these cases the 

14 rapid availability of cryopreserved cord blood stem 

15 cell units may be important. Years later, those ex16 posed would incur an increased risk of leukemia 

17 orlymphoma, which might also require stem cell 

18 transplantation. 

19 (11) Recent scientific developments suggest 

20 that further research on cord blood stem cells may 

21 lead to a greater understanding of certain chronic 

22 diseases. This research might improve therapies for, 

23 and possibly cure, debilitating diseases such as Par24 kinson’s disease, insulin-dependent diabetes, heart 

25 disease, and certain types of cancer. These diseases 
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1 cause a disproportionately large share of chronic dis2 abilities and account for a large portion of health 

3 care expenditures in the United States. 

4 SEC. 3. NATIONAL CORD BLOOD STEM CELL BANK NET5 WORK. 

6 Part H of title III of the Public Health Service Act 

7 (42 U.S.C. 273 et seq.) is amended by inserting after sec8 tion 376 the following: 

9 ‘‘SEC. 376A. NATIONAL CORD BLOOD STEM CELL BANK NET10 WORK. 

11 ‘‘(a) DEFINITIONS.—In this section: 

12 ‘‘(1) ADMINISTRATOR.—The term ‘Adminis13 trator’ means the Administrator of the Health Re14 sources and Services Administration. 

15 ‘‘(2) CORD BLOOD UNIT.—The term ‘cord blood 

16 unit’ means the blood collected from a single pla17 centa and umbilical cord. 

18 ‘‘(3) DONOR.—The term ‘donor’ means a moth19 er who has delivered a baby and consents to donate 

20 the newborn’s blood remaining in the placenta and 

21 umbilical cord. 

22 ‘‘(4) DONOR BANK.—The term ‘donor bank’ 

23 means a qualified cord blood stem cell bank that en24 ters into a contract with the Secretary under sub25 section (b)(1). 
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1 ‘‘(5) HUMAN CORD BLOOD STEM CELLS.—The 

2 term ‘human cord blood stem cells’ means 

3 hematopoietic stem cells and any other stem cells 

4 contained in the neonatal blood collected imme5 diately after the birth from the separated placenta 

6 and umbilical cord. 

7 ‘‘(6) NATIONAL CORD BLOOD STEM CELL BANK

8 NETWORK.—The term ‘National Cord Blood Stem 

9 Cell Bank Network’ means a network of qualified 

10 cord blood stem cell banks established under sub11 section (b). 

12 ‘‘(b) NATIONAL CORD BLOOD STEM CELL BANK

13 NETWORK.—

14 ‘‘(1) IN GENERAL.—The Secretary, acting 

15 through the Administrator, shall enter into contracts 

16 with qualified cord blood stem cell banks to assist in 

17 the establishment, provision, and maintenance of a 

18 National Network of Cord Blood Stem Cell Banks 

19 that contains at least 150,000 units of human cord 

20 blood stem cells. 

21 ‘‘(2) PURPOSE OF DONOR BANKS.—It is the 

22 purpose of the donor banks that are a part of the 

23 Network to—

24 ‘‘(A) acquire, tissue-type, test, 

25 cryopreserve, and store donated units of human 
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1 cord blood acquired with the informed consent 

2 of the donor, in a manner that complies with 

3 applicable Federal regulations; 

4 ‘‘(B) make cord blood units collected under 

5 this section, or otherwise, available to trans6 plant centers for stem cell transplantation; and 

7 ‘‘(C) allocate up to 10 percent of the cord 

8 blood inventory each year for peer-reviewed re9 search. 

10 ‘‘(3) ELIGIBILITY OF DONOR BANKS.—A cord 

11 blood stem cell bank shall be eligible to be a donor 

12 bank if such a bank—

13 ‘‘(A) has obtained all applicable Federal 

14 and State licenses, certifications, registrations 

15 (including registration with the Food and Drug 

16 Administration), and other authorizations re17 quired to operate and maintain a cord blood 

18 stem cell bank; 

19 ‘‘(B) has implemented donor screening and 

20 cord blood collection practices adequate to pro21 tect both donors and transplant recipients and 

22 to prevent transmission of potentially harmful 

23 infections and other diseases; 

24 ‘‘(C) has established a system of strict con25 fidentiality to protect the identity and privacy 
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1 of patients and donors in accordance with exist2 ing Federal and State law, and consistent with 

3 the regulations promulgated under section 

4 264(c) of the Health Insurance Portability and 

5 Accountability Act of 1996 for the release of 

6 the identity of donors, recipients, or identifiable 

7 records; 

8 ‘‘(D) has established a system for encour9 aging donation by an ethnically diverse group of 

10 donors; 

11 ‘‘(E) has developed adequate systems for 

12 communication with other cord blood stem cell 

13 banks, transplant centers, and physicians with 

14 respect to the request, release, and distribution 

15 of cord blood units nationally and has developed 

16 such systems, consistent with the regulations 

17 promulgated under section 264(c) of the Health 

18 Insurance Portability and Accountability Act of 

19 1996, to track recipients’ clinical outcomes for 

20 distributed units; and 

21 ‘‘(F) has developed a system for educating 

22 the public, including patient advocacy organiza23 tions, about the benefits of donating and uti24 lizing cord blood stem cells in appropriate cir25 cumstances. 
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1 ‘‘(c) ADMINISTRATION OF THE NETWORK.—

2 ‘‘(1) BOARD OF DIRECTORS.—

3 ‘‘(A) IN GENERAL.—The Secretary shall 

4 provide for the establishment of a Board of Di5 rectors, including a chairperson, who shall ad6 minister the National Cord Blood Stem Cell 

7 Bank Network, including establishing a na8 tional cord blood stem cell registry within the 

9 Network and coordinating the donor banks in 

10 the Network. 

11 ‘‘(B) COMPOSITION.—

12 ‘‘(i) IN GENERAL.—The Board of Di13 rectors shall be composed of members to 

14 be appointed by the Secretary who shall 

15 serve 3-year terms, and shall include rep16 resentatives from—

17 ‘‘(I) cord blood stem cell trans18 plant centers; 

19 ‘‘(II) physicians from partici20 pating birthing hospitals; 

21 ‘‘(III) the cord blood stem cell re22 search community; 

23 ‘‘(IV) recipients of cord blood 

24 stem cell transplants; 
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1 ‘‘(V) family members of a patient 

2 of the National Cord Blood Stem Cell 

3 Bank; 

4 ‘‘(VI) individuals with expertise 

5 in the social sciences; 

6 ‘‘(VII) members of the general 

7 public; 

8 ‘‘(VIII) the Division of Stem Cell 

9 Transplantation of the Health Re10 sources and Services Administration, 

11 who shall serve as nonvoting member; 

12 and 

13 ‘‘(IX) the network donor banks. 

14 ‘‘(ii) TERMS OF SERVICE.—Each 

15 member appointed under clause (i) may 

16 serve up to 2 consecutive 3-year terms, ex17 cept that this clause shall not apply to the 

18 members appointed under subclauses 

19 (VIII) and (IX) of clause (i). 

20 ‘‘(C) CONTINUITY.—In order to ensure the 

21 continuity of the Board of Directors, the Board 

22 shall be appointed so that each year the terms 

23 of approximately 1/3 of the Board members ex24 pire. A member of the Board may continue to 
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1 serve after the expiration of the term of such a 

2 member until a successor is appointed. 

3 ‘‘(2) NATIONAL CORD BLOOD STEM CELL REG4 ISTRY.—

5 ‘‘(A) IN GENERAL.—The Secretary, acting 

6 through the Administrator, shall establish as 

7 part of the Network a National Cord Blood 

8 Stem Cell Registry. The Registry shall—

9 ‘‘(i) operate a system for identifying, 

10 acquiring, and distributing donated units 

11 of cord blood that are suitably matched to 

12 candidate patients; 

13 ‘‘(ii) provide transplant physicians 

14 and other appropriate health care profes15 sionals a website function that enables 

16 searching the entire registry for suitable 

17 donor matches for patients, and requesting 

18 specific cord blood units; and 

19 ‘‘(iii) maintain a database to docu20 ment the collection, storage, distribution, 

21 and transplantation of cord blood units 

22 and the clinical outcomes of all 

23 transplantations related to the Network. 

24 ‘‘(B) DATABASE.—The database main25 tained under subparagraph (A)(iii) shall be op-
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1 erated according to standards of consent, dis2 closure, and confidentiality, including those ap3 plicable under the regulations promulgated 

4 under section 264(c) of the Health Insurance 

5 Portability and Accountability Act of 1996. The 

6 Administrator, using the database, shall report 

7 to the Secretary on a periodic basis regarding 

8 the safety, efficacy, and cost-effectiveness of the 

9 clinical, research, and educational activities of 

10 the Network. The Secretary shall make such in11 formation available to the public. 

12 ‘‘(3) NETWORK STANDARDS.—The Board of Di13 rectors shall ensure that—

14 ‘‘(A) the donor banks within the National 

15 Cord Blood Stem Cell Bank Network meet the 

16 requirements of subsection (b)(3) on a con17 tinuing basis; and 

18 ‘‘(B) the National Cord Blood Stem Cell 

19 Bank Network and their birthing hospital col20 lection sites be geographically distributed 

21 throughout the United States. 

22 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—For the 

23 purpose of carrying out this section, there are authorized 

24 to be appropriated $15,000,000 for fiscal year 2004, and 

25 $30,000,000 for fiscal year 2005 and such sums as may 
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1 be necessary for each of fiscal years 2006 through 2008 

2 or until the 150,000 unit inventory is successfully ac3 quired.’’.

Æ