Autologous Bone Marrow Mononuclear Cell Implantation for 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.
|Peripheral Arterial Disease||Procedure: Bone marrow mononuclear cell implantation|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Major limb amputation [ Time Frame: three months ]
- Improved ABI measurements [ Time Frame: three months ]
- Relief of rest pain [ Time Frame: three months ]
- Ulceration healing [ Time Frame: three months ]
|Study Start Date:||December 2007|
|Study Completion Date:||March 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
|Experimental: Stem Cell Implantation||
Procedure: Bone marrow mononuclear cell implantation
Dual intramuscular and intra-arterial injections of bone marrow mononuclear cells harvested from the iliac crest. Injection sites are determined by location of stenosis and/or occlusion on angiogram obtained prior to implantation and typically occur in three medial and three lateral sites approximating the disease location.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00919516
|United States, Ohio|
|The Vascular and Vein Center|
|Columbus, Ohio, United States, 43215|
|Principal Investigator:||Randall W Franz, MD||The Vascular and Vein Center|