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

Phase 2

Completed

• Conditions: Arterial Occlusive Diseases
• Interventions: Procedure: intraarterial stem cell therapy; Other: Stem cells

• Registration Number: NCT00282646
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

Brief Summary

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

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

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2006-01-25
• Study First Submitted QC: 2006-01-25
• Study First Posted: 2006-01-27
• Primary Completion: 2010-10
• Study Completion: 2011-03
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-18
• Last Update Posted: 2021-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	intraarterial stem cell therapy	intraarterial application of bone marrow mononuclear cells
2	intraarterial stem cell therapy	intraarterial application of placebo
1	Stem cells	intraarterial application of bone marrow mononuclear cells
2	Stem cells	intraarterial application of placebo

Primary Outcome Measures

Name	Time	Method
Ankle brachial index	6 months

Secondary Outcome Measures

Name	Time	Method
Walking distance	6 months
Ulcer size	6 months
Pain	6 months
TCO2	6 months

Trial Locations

Locations (1)

Div. of Cardiology and Vascular Medicine; 🇩🇪 Frankfurt, Germany