Autologous Bone Marrow Mononuclear Cell Implantation for Moderate to Severe Peripheral Arterial Disease

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy of dual intramuscular and intra-arterial autologous bone marrow mononuclear cell implantation for the treatment of patients with moderate to severe peripheral arterial disease in whom amputation was considered the only viable treatment option. Study Hypothesis: Patients with moderate to severe peripheral arterial disease who receive intramuscular and intra-arterial stem cell injections will have improved ankle brachial index (ABI) measurements; relief of rest pain; ulcer healing, if applicable; and absence of major limb amputations.

Official Title
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Use of Autologous Bone-Marrow Mononuclear Cell Implantation Therapy as a Limb Salvage Procedure in Patients With Moderate to Severe Peripheral Arterial Disease

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Procedure: Bone marrow mononuclear cell implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients at least 18 years of age. Patients with moderate or severe limb-threatening PAD, defined as ankle brachial indices (ABI) less than 0.7 or presence of non-healing ischemic ulcers with stenosis or occlusion of two of the following lower extremity arteries: anterior tibial, posterior tibial, and peroneal. Patients with conditions that preclude recommendation of traditional endovascular or open bypass treatments. Exclusion Criteria: Patients younger than 18 years of age. Patients who are eligible to undergo traditional endovascular or open bypass for the treatment of PAD. Female patients who are or may be pregnant. Patients who are prisoners. Patients with mental retardation or are unable to consent for participation independently.

Ages Eligible for Study
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Minimum Age: 18 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: Stem Cell Implantation<br> | Procedure: Bone marrow mononuclear cell implantation<br>* Dual intramuscular and intra-arterial injections of bone marrow mononuclear cells harvested from the iliac crest. Injection sites are determined by location of stenosis and/or occlusion on angiogram obtained prior to implantation and typically occur in three medial and three lateral sites approximating the disease location.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major limb amputation |  | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved ABI measurements |  | three months | 
| Relief of rest pain |  | three months | 
| Ulceration healing |  | three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone marrow transplantation, Ischemia, Neoangiogenesis, Peripheral arterial disease, Stem cell therapy