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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
catheter delivery of stem cells
intraarterial application of bone marrow mononuclear cells versus placebo
Div. of Cardiology and Vascular Medicine
Frankfurt, Germany
Ankle brachial index
Time frame: 6 months
Ulcer size
Time frame: 6 months
Pain
Time frame: 6 months
Walking distance
Time frame: 6 months
TCO2
Time frame: 6 months
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