Safety Study of Using Stem Cells to Stimulate Development of New Blood Vessels in Peripheral Vascular Disease

Study Overview
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Brief Summary
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The purpose of this study is to determine if bone marrow derived adult stem cells are safe and effective in inducing development of new blood vessels (angiogenesis) in the legs of patients with severe peripheral vascular disease.

Detailed Description
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Presently there are no effective medical therapies to enhance blood flow in the legs of patients with peripheral vascular disease. For patients with limb threatening ischemia the only option for relief of rest pain or gangrene is amputation. There is evidence in animal and clinical studies that adult stem cells in the bone marrow, called endothelial progenitor cells, participate in the development of new blood vessels, a process called angiogenesis. In this investigation, patients with limb threatening ischemia will have their bone marrow harvested and the stem cells will then be removed and injected directly into the muscle of the diseased leg. The procedure will require about 4 hours and the subjects will be admitted to the Indiana University Medical Center overnight. The follow-up period is 12 weeks and the analysis will consist of examinations at 1, 2, 4, 6, 8, and 12 weeks. Adverse and serious adverse events will be recorded during this time period. Diagnostic studies will be obtained to measure blood flow in the treated leg during the follow up period and include transcutaneous (skin) oxygen measurements, pressure recordings in the leg, arteriography, magnetic resonance imaging, and wound healing.

Official Title
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Phase I Study of Stem Cell Mediated Angiogenesis for Limb Threatening Ischemia

Conditions
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Peripheral Vascular Diseases

Intervention / Treatment
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* Drug: adult stem cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe peripheral vascular disease not amenable to bypass or angioplasty Age >21 years old Normal renal function (creatinine < 1.6) Exclusion Criteria: Congestive heart failure (ejection fraction [EF]<30%) History of cancer or myeloproliferative disorders Proliferative retinopathy Pregnancy Cognitively disabled

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: adult stem cells|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events recorded in the 12 week study period |  |  | 
| Serious Adverse events recorded for one year |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in limb perfusion after treatment with stem cells will be assessed with arteriography, blood pressure recordings, oxygen measurements, and wound healing |  |  |