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

Peripheral Arterial Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00919516
• Other study ID #: FRANZ-07-0046
• Status: Completed
• Phase: N/A
• First received: June 11, 2009
• Last updated: December 10, 2014
• Start date: December 2007
• Est. completion date: March 2013

Study information

• Verified date: December 2014
• Source: The Vascular and Vein Center, Columbus, OH
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: March 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	The Vascular and Vein Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Vascular and Vein Center, Columbus, OH

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major limb amputation		three months	No
Secondary	Improved ABI measurements		three months	No
Secondary	Relief of rest pain		three months	No
Secondary	Ulceration healing		three months	No