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

Johann Wolfgang Goethe University Hospital

Status and phase: Completed; Phase 2

Conditions: Arterial Occlusive Diseases

Treatments: Procedure: intraarterial stem cell therapy; Other: Stem cells

Study type: Interventional

Funder types: Other

Identifiers

NCT00282646

2005-000968-33

PROVASA

Details and patient eligibility

About

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.

Full description

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

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

intraarterial application of bone marrow mononuclear cells

Treatment:

Procedure: intraarterial stem cell therapy

Other: Stem cells

2

Placebo Comparator group

Description:

intraarterial application of placebo

Treatment:

Procedure: intraarterial stem cell therapy

Other: Stem cells