Mesenchymal Stem Cells in Critical Limb Ischemia

Study Overview
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Brief Summary
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This clinical trial aims to study the safety and efficacy of adult mesenchymal stem cells in critical limb ischemia.

Official Title
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A Randomized, Double Blind, Multicentric, Placebo Controlled, Single Dose, Phase - i/ii Study Assessing the Safety and Efficacy of Intramuscular ex Vivo Cultured Adult Allogenic Mesenchymal Stem Cells in Patients With Critical Limb Ischemia (Cli)

Conditions
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Critical Limb Ischemia

Intervention / Treatment
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* Drug: mesenchymal stem cells
* Drug: Plasmalyte A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females with non-child bearing potential in the age group of 18-60 yrs of Indian origin. Established CLI, clinically and hemodynamically confirmed as per Rutherford- II-4, III-5, or III-6; Patients having Infra-inguinal arterial occlusive disease with rest pain or ischemic ulcer/necrosis, who are not eligible for or have failed traditional revascularization treatment (No option patients) Ankle Brachial Pressure Index (ABPI) ≤ 0.6 or ankle pressure ≤ 70 mm Hg or TcPO2 ≤ 60 mmHg in the foot Patients if having associated Type II Diabetes, should be on medication and well controlled (HbA1c ≤ 8%) without complications Patients who are able to understand the requirements of the study, and willing to provide voluntary written informed consent, abide by the study requirements, and agree to return for required follow-up visits Normal liver and renal function On regular medication for hypertension if any Exclusion Criteria: Patients with CLI suitable for surgical or percutaneous revascularization as determined by the surgeon performing vascular procedure and patients with any acute/chronic inflammatory condition CLI patient requiring amputation proximal to trans-metatarsal level Patients with gait disturbance for reasons other than CLI. Type I diabetes Patients having respiratory complications/left ventricular ejection fraction < 25%f) Stroke or myocardial infarction within last 3 months Patients who are contraindicated for MRA Have clinically serious and/or unstable inter-current infection, medical illnesses or conditions that are uncontrolled or whose control, in the opinion of the Investigator, may be jeopardized by participation in this study or by the complications of this therapy Documented terminal illness or cancer or any concomitant disease process with a life expectancy of less than 1 year Patients already enrolled in another investigational drug trial or completed within 3 months. History of severe alcohol or drug abuse within 3 months of screening. Hb% < 10 gm%, Serum Creatinine ≥ 2mg%, Serum Total Bilirubin ≥2mg%, HbA1c > 8% Women with child bearing potential, pregnant and lactating women. Patients tested positive for HIV 1, HCV, HBV,

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mesenchymal stem cells<br>Intramuscular injection | Drug: mesenchymal stem cells<br>* Intramuscular injection<br>|
| Experimental: Placebo<br>Intramuscular injection | Drug: Plasmalyte A<br>* Intramuscular injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AE and symptomatic relief |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in transcutaneous partial oxygen pressure (TcPO2) and Ankle brachial pressure index (ABPI) - measured by Doppler |  | 6 months | 

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