Safety and Feasibility Study of Autologous Bone Marrow Cell Transplantation in Patients With Peripheral Arterial Occlusive Disease (PAOD)

Study Overview
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Brief Summary
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Patients with peripheral artery disease, stage III or IV who are not candidates for interventional or operative therapy should be treated with intraarterial progenitor cell therapy (autologous bone marrow cells) in a randomized, placebo controlled trial.

Detailed Description
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Main goal: Improvement of limb perfusion (Ankle brachial index). Secondary aims: Reduction of pain Reduction of Ulcer size Walking distance Improvement in tissue oxygenation (TCO2) Minor or major amputation

Official Title
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(Intraarterial Progenitor Cell Transplantation of Bone Marrow Mononuclear Cells for Induction of Neovascularization in Patients With Peripheral Arterial Occlusive Disease)

Conditions
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Arterial Occlusive Diseases

Intervention / Treatment
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* Procedure: intraarterial stem cell therapy
* Other: Stem cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with PAOD (Stage III or IV) Distal arterial occlusions Patients with Buergers Disease Signed informed consent Exclusion Criteria: Successful bypass operation or intervention within the last 3 months Active infection, feber, chronic inflammatory disease HIV, Hepatitis Tumor within the last 5 years, complete remission required Stroke or myocardial infarction within last 3 months Renal insufficiency (creatinine > 2 mg/dl) Liver disease (GOT > 2x upper limit oder spontaneous INR > 1,5). Anemia (hemoglobin < <10 mg/dl) Thrombocytopenia < 100.000/µl Allergies to Aspirin, Clopidogrel, Heparin Bleeding disorder Gastrointestinal bleeding within last 3 months Surgery or trauma within the last 2 months Pregnancy Mental retardation Inclusion in other clinical study within last 30 days

Ages Eligible for Study
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Minimum Age: 18 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: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intraarterial administration of BM-MNC or placebo
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>intraarterial application of bone marrow mononuclear cells | Procedure: intraarterial stem cell therapy<br>* catheter delivery of stem cells<br>Other: Stem cells<br>* intraarterial application of bone marrow mononuclear cells versus placebo<br>|
| Placebo Comparator: 2<br>intraarterial application of placebo | Procedure: intraarterial stem cell therapy<br>* catheter delivery of stem cells<br>Other: Stem cells<br>* intraarterial application of bone marrow mononuclear cells versus placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ankle brachial index |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ulcer size |  | 6 months | 
| Pain |  | 6 months | 
| Walking distance |  | 6 months | 
| TCO2 |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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critical limb ischemia, peripheral arterial occlusive disease, [C14.907.137]