Autologous Bone Marrow Mononuclear Cell Implantation for Moderate to Severe Peripheral Arterial Disease

NCT00919516 | Completed

• 1 other identifier: FRANZ-07-0046
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Peripheral Arterial Disease

Keywords

Bone marrow transplantation; Ischemia; Neoangiogenesis; Peripheral arterial disease; Stem cell therapy

Outcome Measures

Primary Outcomes (1)

• Major limb amputation

  three months

Secondary Outcomes (3)

• Improved ABI measurements

  three months

• Relief of rest pain

  three months

• Ulceration healing

  three months

Study Arms (1)

Stem Cell Implantation

EXPERIMENTAL

Procedure: Bone marrow mononuclear cell implantation

Interventions

Bone marrow mononuclear cell implantation PROCEDURE

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.

Stem Cell Implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Vascular and Vein Center, Columbus, OH: lead

Study Sites (1)

The Vascular and Vein Center

Columbus, Ohio, 43215, United States

Location

Related Publications (2)

• 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.

  PMID: 19837539 RESULT

• 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.

  PMID: 26304481 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Ischemia; Neovascularization, Pathologic

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Metaplasia

Study Officials

• Randall W Franz, MD

  The Vascular and Vein Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2009
• First Posted: June 12, 2009
• Study Start: December 1, 2007
• Primary Completion: January 1, 2013
• Study Completion: March 1, 2013
• Last Updated: December 11, 2014

Record last verified: 2014-12

Locations

US (1)