Autologous Bone Marrow Mononuclear Cell Implantation for Moderate to Severe Peripheral Arterial Disease
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|ClinicalTrials.gov Identifier: NCT00919516|
Recruitment Status : Completed
First Posted : June 12, 2009
Last Update Posted : December 11, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease||Procedure: Bone marrow mononuclear cell implantation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||March 2013|
|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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|