- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00919516
Autologous Bone Marrow Mononuclear Cell Implantation for Moderate to Severe Peripheral Arterial Disease
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43215
- The Vascular and Vein Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Stem 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Major limb amputation
Time Frame: three months
|
three months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improved ABI measurements
Time Frame: three months
|
three months
|
Relief of rest pain
Time Frame: three months
|
three months
|
Ulceration healing
Time Frame: three months
|
three months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Randall W Franz, MD, The Vascular and Vein Center
Publications and helpful links
General Publications
- Franz RW, Parks A, Shah KJ, Hankins T, Hartman JF, Wright ML. Use of autologous bone marrow mononuclear cell implantation therapy as a limb salvage procedure in patients with severe peripheral arterial disease. J Vasc Surg. 2009 Dec;50(6):1378-90. doi: 10.1016/j.jvs.2009.07.113. Epub 2009 Oct 17.
- Franz RW, Shah KJ, Pin RH, Hankins T, Hartman JF, Wright ML. Autologous bone marrow mononuclear cell implantation therapy is an effective limb salvage strategy for patients with severe peripheral arterial disease. J Vasc Surg. 2015 Sep;62(3):673-80. doi: 10.1016/j.jvs.2015.02.059.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FRANZ-07-0046
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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