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

NCT ID: NCT00919516

Last Updated: 2014-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2013-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Peripheral Arterial Disease

Keywords

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Bone marrow transplantation Ischemia Neoangiogenesis Peripheral arterial disease Stem cell therapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stem Cell Implantation

Group Type EXPERIMENTAL

Bone marrow mononuclear cell implantation

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Vascular and Vein Center, Columbus, OH

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Randall W Franz, MD

Role: PRINCIPAL_INVESTIGATOR

The Vascular and Vein Center

Locations

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The Vascular and Vein Center

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 19837539 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26304481 (View on PubMed)

Other Identifiers

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FRANZ-07-0046

Identifier Type: -

Identifier Source: org_study_id