Status:
COMPLETED
Safety and Feasibility Study of Autologous Bone Marrow Cell Transplantation in Patients With Peripheral Arterial Occlusive Disease (PAOD)
Lead Sponsor:
Johann Wolfgang Goethe University Hospital
Conditions:
Arterial Occlusive Diseases
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 ma...
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 a...
Eligibility Criteria
Inclusion
- Patients with PAOD (Stage III or IV)
- Distal arterial occlusions
- Patients with Buergers Disease
- Signed informed consent
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00282646
Start Date
October 1 2005
End Date
March 1 2011
Last Update
October 26 2021
Active Locations (1)
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1
Div. of Cardiology and Vascular Medicine
Frankfurt, Germany, 60590