Umbilical Cord Mesenchymal Stem Cells Injection for Peripheral Arterial Disease

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and efficacy of umbilical cord blood mesenchymal stem cells with peripheral arterial disease.

Detailed Description
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The present study is designed to implant UCB-MSC in patients with CLI, which are resulted from peripheral arterial disease,such as thromboangiitis obliterans, atherosclerosis obliterans and diabetic foot, and to evaluate the safety and efficacy of the implantation procedure.

Official Title
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Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Injection for Peripheral Arterial Disease

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Biological: umbilical cord mesenchymal stem cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 18-75 years Patients confirmed diagnosed peripheral vascular disease , ankle-brachial index < 0.9 Poor distal arterial outflow tract Patient had at least 3 months conservative treatment ,which resulted in little or no improvement Poor physical condition can not tolerate surgery Patients are willing to participate in the study and sign the informed consent. Exclusion Criteria: Renal function damage (over 2 X upper normal range) Liver function damage (over 3 X upper normal range ) Severe or acute organ damage Presence of malignancy Pregnancy or lactating patients HIV positive ABI≧0.9 A history of severe allergies related cell therapy Conservative treatment < 3 months Acute limb ischemia Local obvious infection uncontrolled Alcoholics or drug abusers within a year Severe psychiatric disorder. Patients need surgical treatment Above the ankle gangrene Patients with other factors which were considered not to be suitable to participate in the study by the investigators.

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
Intervention Model: Single Group 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> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate safety and tolerability related to the intramuscular injection of autologous Umbilical cord blood derived stem cells. | Amputation rate and mortality will be combined to report safty in % | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate effectiveness related to the intramuscular injection of autologous Umbilical cord blood derived stem cells. | Rest pain, temperature of skin and cold feeling will be combined to report effectiveness in score. | 6 months |