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OpenTrials
Completed

NCT Number: NCT00919516

Autologous Bone Marrow Mononuclear Cell Implantation for 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Vascular and Vein Center

Columbus, Ohio, 43215, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Major limb amputation

    Time frame: three months

Secondary outcomes

  1. Improved ABI measurements

    Time frame: three months

  2. Relief of rest pain

    Time frame: three months

  3. Ulceration healing

    Time frame: three months

Sponsors and collaborators

Lead sponsor

The Vascular and Vein Center, Columbus, OH

Other

Registry information

Official study title

Use of Autologous Bone-Marrow Mononuclear Cell Implantation Therapy as a Limb Salvage Procedure in Patients With Moderate to Severe Peripheral Arterial Disease

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Jun 12, 2009
Registry last updated
Dec 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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