Umbilical Cord Mesenchymal Stem Cells Injection for Diabetic Foot

Study Overview
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Brief Summary
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The purpose of this study is to determine whether umbilical cord Mesenchymal Stem Cells of treatment for diabetic foot is safe and effective in the management of diabetic foot ischemia, the therapeutic effect of stem cells is caused by improving blood circulation in ischemic limb which would in turn promote ulcer healing, prevent amputation of limb and relieve the Sevier pain of ischemia.

Detailed Description
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Type 2 diabetic patients with diabetic foot were enrolled and randomized to either transplanted group or control group. Patients in transplanted group received the stem cells treatment,Patients in control group received the standard treatment. After culture in vitro, umbilical cord mesenchymal stem cells should go through safety evaluation which include culture and check of pathogenic microorganisms (bacteria, mycoplasma, chlamydia, eumycete and viruses) of the cells medium and karyotype analysis of the mesenchymal stem cells. Only the safe cells were harvested and transplanted by multiple intramuscular injections into the impaired lower limbs. Follow-up index include: efficacy (pain,ulcer healing rate, lower limb amputation rate and ,ankle-brachial index,magnetic resonance angiography,electromyogram) and safety (infection of the injection site, fever, and tumour generation).

Official Title
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Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Injection for Diabetic Foot

Conditions
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Diabetic Foot, Critical Limb Ischemia, Mesenchymal Stem Cells, Umbilical Cord

Intervention / Treatment
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* Biological: umbilical cord mesenchymal stem cells
* Drug: Standard Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diabetes mellitus Type 2 Age 18 - 75 years Subject has an Ankle-brachial index < 0.9 Subject has had previous conservative treatment which resulted in little or no improvement Subject has had no stem cell treatment within the past 6 months No sufficient response to best standard care delivered for six weeks. No surgical or radiological interventional option for revascularisation as confirmed by a vascular surgeon and an interventional radiologist Signed informed consent Absence of life-threatening complications from the ischemic limb Life expectancy more than 2 years Negative pregnancy test when applicable Exclusion Criteria: Diabetic retinopathy History of neoplasm or hematological disease Uncontrolled high blood pressure (>180/110) Severe cardiac insufficiency (New York Heart Association [NYHA] IV) or ejection fraction<30% Malignant ventricular arrythmia Deep venous thrombosis during the last 3 months Active bacterial infection Body mass index > 35 Kg/m2 Stroke or myocardial infarction during the last 3 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: umbilical cord mesenchymal stem cells<br>Multiple intra muscular injection of mesenchymal stem cells derived from human umbilical cord. | Biological: umbilical cord mesenchymal stem cells<br>* 5*10/7 per ischemic limb<br>* Other names: mesenchymal stem cells;|
| Active Comparator: Standard Therapy<br>Any therapy for diabetic foot which is routinely practiced and accepted in China | Drug: Standard Therapy<br>* Any thing directed to improve blood perfusion in the limb example.Heparin,Antiplatelet agents etc<br>* Other names: Drug therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angiographic evaluation of angiogenesis at ischemic limb |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain |  | 3 months | 
| Ankle-Brachial pressure index |  | 3 months | 
| Wound healing (wound size, wound stage) |  | 3 months | 
| Walking distance |  | 3 months | 
| Rate and extent of amputations |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic foot, critical limb ischemia, mesenchymal stem cells, umbilical cord