A Clinical Study Using Autologous Bone Marrow Stem Cell for Diabetes Related Vascular Complications

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Clinical Study Using Autologous Bone Marrow Stem Cell for Diabetes Related Vascular Complications

Conditions
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Peripheral Vascular Disease, Ischemia, Diabetic Foot

Intervention / Treatment
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* Biological: mesenchymal stem cells
* Biological: saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous Bone Marrow Stem Cell<br>Mesenchymal stem cells derived from bone marrow infusion | Biological: mesenchymal stem cells<br>* stem cell acquisition, processing and reinfection, to evaluate the efficacy by using autologous bone marrow stem cell<br>|
| Placebo Comparator: saline<br>saline injections | Biological: saline<br>* saline injections<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area of diabetic foot ulcers | To determine the ability of MSC to facilitate and accelerate diabetic foot ulcers healing. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of transcutaneous oxygen partial pressure (TcPO2) | Improvement of local perfusion. | 3 months | 
| Improvement of microvascular cutaneous reactivity by laser Doppler perfusion monitoring (LDPM) |  | 3 months | 
| Pain (Visual-Analog Scale) | Measure of the subjective symptom of pain. | 3 months | 
| Walking distance (treadmill) if possible |  | 3 months |