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

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

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.

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

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