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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00919516
Recruitment Status : Completed
First Posted : June 12, 2009
Last Update Posted : December 11, 2014
Sponsor:
Information provided by (Responsible Party):
The Vascular and Vein Center, Columbus, OH

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.


Condition or disease Intervention/treatment
Peripheral Arterial Disease Procedure: Bone marrow mononuclear cell implantation

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2007
Primary Completion Date : January 2013
Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Major limb amputation [ Time Frame: three months ]

Secondary Outcome Measures :
  1. Improved ABI measurements [ Time Frame: three months ]
  2. Relief of rest pain [ Time Frame: three months ]
  3. Ulceration healing [ Time Frame: three months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00919516


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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The Vascular and Vein Center, Columbus, OH
ClinicalTrials.gov Identifier: NCT00919516     History of Changes
Other Study ID Numbers: FRANZ-07-0046
First Posted: June 12, 2009    Key Record Dates
Last Update Posted: December 11, 2014
Last Verified: December 2014

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
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases