Safety and Efficacy of Autologous Bone Marrow Stem Cells for Lower Extremity Ischemia Treating

Study Overview
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Brief Summary
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The purpose of this study is to determine whether autologous bone marrow-derived stem cells are effective in the treatment of lower extremity ischemia.

Detailed Description
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Critical limb ischemia (CLI) is a debilitating and disabling disease. Symptoms include pain at rest, loss of tissue integrity, distal amputations and have a major impact on the quality of life. Despite recent advances in surgical vascular procedures, a large number of patients (approximately 40%) are not eligible for these revascularization procedures. New strategies for revascularization need to be explored. Besides, in some cases results of such interventions do not give desirable effect, search of new methods of treatment therefore is necessary. Recent evidence indicates that bone marrow-derived mononuclear cells (BM-MNC) are a potential new therapeutic target.

Official Title
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Multicentric Study of the Autologous Bone Marrow-derived Mononuclear Cells Injection for Treatment of the Patients With Critical Lower Extremity Ischemia

Conditions
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Lower Extremity Ischemia, Leg Ulcer, Peripheral Vascular Disease, Diabetic Foot, Gangrene

Intervention / Treatment
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* Procedure: BM-MNC injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Critical lower limb ischemia, defined as ischemic pain at rest and / or the presence of minor tissue loss, with the possibility of healing. Failure of conventional medical treatment and attempts to open or percutaneous revascularization before, with an observation period of two months after the last attempt at revascularization. Patients considered at high risk for new revascularization procedure by at least two independent observers. Exclusion Criteria: Expected life span less than six months Large tissue loss in the ischemic limb indicating the need for limb amputation in the short term. Evidence of osteomyelitis in the ischemic extremity. Current or previous history of neoplasia. Unstable angina, recent stroke or other medical condition that contraindicate anesthesia for bone marrow aspiration. Proliferative retinopathy. Debilitating disease with a life span less than one year. Myelofibrosis, myelodysplasia or other diseases that affect the bone marrow. Use of alcohol in excess of twice-daily doses or history of illicit drug use. Need for continuous high doses of drug therapy with steroids (more than 7.5 mg/day). Positivity for HIV or syphilis

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: BM-MNC injection<br>Injection of autologous bone marrow-derived mononuclear cells | Procedure: BM-MNC injection<br>* BM-MNC cells will be injected in aliquots of 1 ml at multiple regions of the leg muscles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing (wound size, wound stage) - monitoring the healing of trophic lesions |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcome classification | Improvement of symptoms, functional capacity, exercises tolerance assessed by change in Rutherford scale of CLI | 3 months, 6 months | 
| Pain and analgesics use |  | 3 months | 
| Quality of life outcome |  | 3 months, 6 months | 
| Improvement of the coronary and collateral circulation. |  | 3 months | 
| Survival without amputation |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lowe extremity ischemia, Bone marrow, Neoangiogenesis