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NCT00282646 Clinical Trial

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

Arterial Occlusive Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00282646
Other study ID # 2005-000968-33
Secondary ID PROVASA
Status Completed
Phase Phase 2
First received
Last updated
Start date October 2005
Est. completion date March 2011

Study information
Verified date October 2021
Source Johann Wolfgang Goethe University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date March 2011
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• intraarterial stem cell therapy
catheter delivery of stem cells
Other:
• Stem cells
intraarterial application of bone marrow mononuclear cells versus placebo

Locations
Country Name City State
Germany Div. of Cardiology and Vascular Medicine Frankfurt

Sponsors (1)
Lead Sponsor Collaborator
Johann Wolfgang Goethe University Hospital

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Ankle brachial index 6 months
Secondary Ulcer size 6 months
Secondary Pain 6 months
Secondary Walking distance 6 months
Secondary TCO2 6 months
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