Status:
COMPLETED
Autologous Bone Marrow Mononuclear Cell Implantation for Moderate to Severe Peripheral Arterial Disease
Lead Sponsor:
The Vascular and Vein Center, Columbus, OH
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 sever...
Eligibility Criteria
Inclusion
- Patients at least 18 years of age.
- Patients with moderate or severe limb-threatening PAD, defined as ankle brachial indices (ABI) less than 0.7 or presence of non-healing ischemic ulcers with stenosis or occlusion of two of the following lower extremity arteries: anterior tibial, posterior tibial, and peroneal.
- Patients with conditions that preclude recommendation of traditional endovascular or open bypass treatments.
Exclusion
- Patients younger than 18 years of age.
- Patients who are eligible to undergo traditional endovascular or open bypass for the treatment of PAD.
- Female patients who are or may be pregnant.
- Patients who are prisoners.
- Patients with mental retardation or are unable to consent for participation independently.
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00919516
Start Date
December 1 2007
End Date
March 1 2013
Last Update
December 11 2014
Active Locations (1)
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1
The Vascular and Vein Center
Columbus, Ohio, United States, 43215