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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by The Vascular and Vein Center, Columbus, OH.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
The Vascular and Vein Center, Columbus, OH
ClinicalTrials.gov Identifier:
NCT00919516
First received: June 11, 2009
Last updated: June 4, 2012
Last verified: June 2012
  Purpose

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 Intervention
Peripheral Arterial Disease
Procedure: Bone marrow mononuclear cell implantation

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

Resource links provided by NLM:


Further study details as provided by The Vascular and Vein Center, Columbus, OH:

Primary Outcome Measures:
  • Major limb amputation [ Time Frame: three months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improved ABI measurements [ Time Frame: three months ] [ Designated as safety issue: No ]
  • Relief of rest pain [ Time Frame: three months ] [ Designated as safety issue: No ]
  • Ulceration healing [ Time Frame: three months ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: December 2007
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: Bone marrow mononuclear cell implantation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00919516

Contacts
Contact: Randall W Franz, MD 614-566-9035 rfranz2@ohiohealth.com

Locations
United States, Ohio
The Vascular and Vein Center Recruiting
Columbus, Ohio, United States, 43215
Principal Investigator: Randall W Franz, MD         
Sponsors and Collaborators
The Vascular and Vein Center, Columbus, OH
Investigators
Principal Investigator: Randall W Franz, MD The Vascular and Vein Center
  More Information

Publications:
Responsible Party: The Vascular and Vein Center, Columbus, OH
ClinicalTrials.gov Identifier: NCT00919516     History of Changes
Other Study ID Numbers: FRANZ-07-0046
Study First Received: June 11, 2009
Last Updated: June 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The Vascular and Vein Center, Columbus, OH:
Bone marrow transplantation
Ischemia
Neoangiogenesis
Peripheral arterial disease
Stem cell therapy

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014