Peripheral Arterial Disease Clinical Trial
Official title:
Use of Autologous Bone-Marrow Mononuclear Cell Implantation Therapy as a Limb Salvage Procedure in Patients With Moderate to Severe Peripheral Arterial Disease
The purpose of this study is to evaluate the efficacy of dual intramuscular and
intra-arterial autologous bone marrow mononuclear cell implantation for the treatment of
patients with moderate to severe peripheral arterial disease in whom amputation was
considered the only viable treatment option.
Study Hypothesis: Patients with moderate to severe peripheral arterial disease who receive
intramuscular and intra-arterial stem cell injections will have improved ankle brachial
index (ABI) measurements; relief of rest pain; ulcer healing, if applicable; and absence of
major limb amputations.
n/a
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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