Clinical trial NCT02796079: A Clinical Study Using Autologous Bone Marrow Stem Cell for Diabetes Related Vascular Complications
Official title: A Clinical Study Using Autologous Bone Marrow Stem Cell for Diabetes Related Vascular Complications
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Peripheral Vascular Disease
Ischemia
Diabetic Foot
Lead sponsor: The Third Affiliated Hospital of Southern Medical University
Sponsor class: OTHER_GOV
Collaborators: name: Nanfang Hospital, Southern Medical University
name: Academy Military Medical Science, China
name: The Fifth Affiliated Hospital of Southern Medical University
name: Southern Medical University, China
First posted: 2016-06-10
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stem cell therapy has been a new and effective therapy in recent years for diabetic foot.This study intends to establish an optimal clinical research program, and attempts to break the technical bottleneck in the stem cell therapy for treating diabetes related vascular complications.

Detailed description: Diabetic foot is one of the most serious chronic complications of diabetic patients, and still lacking effective treatments.

Stem cell therapy has been a new and effective therapy in recent years for diabetic foot. Combined with the previous studies of our research group, this study intends to transform part of the results of this research, establish an optimal clinical research program, and attempts to break the technical bottleneck in the stem cell therapy for treating diabetes related vascular complications.

Eligibility criteria: Inclusion Criteria:

* Diabetes mellitus Type 2 or Type 1
* Age between 18-80 years
* Chronic foot ulcer more than 6 weeks
* No sufficient response to best standard care delivered for six weeks.
* PAD up to Fontaine stage III or IV period
* CLI with the ankle brachial index (index ankle-brachial, ABI) \<0.7 and (or) the percutaneous oxygen partial pressure (oxygen tension transcutaneous, TcPO2) \<30mmHg

Exclusion Criteria:

* HbA1c \>12%
* Hemoglobin \<10 mg/dl
* Creatinine clearance rate \<30ml/min
* Systemic bacterial, viral infections (Mei Du, hepatitis, cytomegalovirus infection, HIV, B19 infection, herpes virus infection) and sepsis
* Have accepted the treatment of stem cells or growth factors
* Have a history of malignant disease
* Pregnancy
* Mental illness history
* Abnormal coagulation function
* Allergic reaction
* Severe cardiac insufficiency (III-IV NYHA)
* Using vasoactive substances

Primary outcomes:
measure: Area of diabetic foot ulcers
timeFrame: 3 months
Secondary outcomes:
measure: Improvement of transcutaneous oxygen partial pressure (TcPO2)
timeFrame: 3 months
measure: Improvement of microvascular cutaneous reactivity by laser Doppler perfusion monitoring (LDPM)
timeFrame: 3 months
measure: Pain (Visual-Analog Scale)
timeFrame: 3 months
measure: Walking distance (treadmill) if possible
timeFrame: 3 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: the Third Affiliated Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: The Third Affiliated Hospital of Southern Medical University
name: Jie Shen
role: PRINCIPAL_INVESTIGATOR
References: