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

Primary Purpose

Peripheral Arterial Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bone marrow mononuclear cell implantation
Sponsored by
The Vascular and Vein Center, Columbus, OH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Bone marrow transplantation, Ischemia, Neoangiogenesis, Peripheral arterial disease, Stem cell therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Vascular and Vein Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stem Cell Implantation

Arm Description

Outcomes

Primary Outcome Measures

Major limb amputation

Secondary Outcome Measures

Improved ABI measurements
Relief of rest pain
Ulceration healing

Full Information

First Posted
June 11, 2009
Last Updated
December 10, 2014
Sponsor
The Vascular and Vein Center, Columbus, OH
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1. Study Identification

Unique Protocol Identification Number
NCT00919516
Brief Title
Autologous Bone Marrow Mononuclear Cell Implantation for Moderate to Severe Peripheral Arterial Disease
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 Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Vascular and Vein Center, Columbus, OH

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
Bone marrow transplantation, Ischemia, Neoangiogenesis, Peripheral arterial disease, Stem cell therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stem Cell Implantation
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Bone marrow mononuclear cell implantation
Intervention Description
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 Measure Information:
Title
Major limb amputation
Time Frame
three months
Secondary Outcome Measure Information:
Title
Improved ABI measurements
Time Frame
three months
Title
Relief of rest pain
Time Frame
three months
Title
Ulceration healing
Time Frame
three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randall W Franz, MD
Organizational Affiliation
The Vascular and Vein Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Vascular and Vein Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19837539
Citation
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.
Results Reference
result
PubMed Identifier
26304481
Citation
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.
Results Reference
derived

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

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