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Safety Study of Using Stem Cells to Stimulate Development of New Blood Vessels in Peripheral Vascular Disease

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ClinicalTrials.gov Identifier: NCT00113243
Recruitment Status : Unknown
Verified June 2005 by Murphy, Michael P., MD.
Recruitment status was:  Recruiting
First Posted : June 7, 2005
Last Update Posted : June 24, 2005
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to determine if bone marrow derived adult stem cells are safe and effective in inducing development of new blood vessels (angiogenesis) in the legs of patients with severe peripheral vascular disease.

Condition or disease Intervention/treatment Phase
Peripheral Vascular Diseases Drug: adult stem cells Phase 1

Detailed Description:

Presently there are no effective medical therapies to enhance blood flow in the legs of patients with peripheral vascular disease. For patients with limb threatening ischemia the only option for relief of rest pain or gangrene is amputation.

There is evidence in animal and clinical studies that adult stem cells in the bone marrow, called endothelial progenitor cells, participate in the development of new blood vessels, a process called angiogenesis. In this investigation, patients with limb threatening ischemia will have their bone marrow harvested and the stem cells will then be removed and injected directly into the muscle of the diseased leg. The procedure will require about 4 hours and the subjects will be admitted to the Indiana University Medical Center overnight. The follow-up period is 12 weeks and the analysis will consist of examinations at 1, 2, 4, 6, 8, and 12 weeks. Adverse and serious adverse events will be recorded during this time period. Diagnostic studies will be obtained to measure blood flow in the treated leg during the follow up period and include transcutaneous (skin) oxygen measurements, pressure recordings in the leg, arteriography, magnetic resonance imaging, and wound healing.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Stem Cell Mediated Angiogenesis for Limb Threatening Ischemia
Study Start Date : December 2004
Estimated Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Adverse events recorded in the 12 week study period
  2. Serious Adverse events recorded for one year

Secondary Outcome Measures :
  1. Changes in limb perfusion after treatment with stem cells will be assessed with arteriography, blood pressure recordings, oxygen measurements, and wound healing

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Severe peripheral vascular disease not amenable to bypass or angioplasty
  • Age >21 years old
  • Normal renal function (creatinine < 1.6)

Exclusion Criteria:

  • Congestive heart failure (ejection fraction [EF]<30%)
  • History of cancer or myeloproliferative disorders
  • Proliferative retinopathy
  • Pregnancy
  • Cognitively disabled
Contacts and Locations

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): NCT00113243


Contacts
Contact: Michael P Murphy, MD (317) 630-8288 mipmurph@iupui.edu
Contact: Julie Lacy, RN (317)962-0138 julacy@iupui.edu

Locations
United States, Indiana
Indiana University School of Medicine Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Michael P Murphy, MD    317-630-8288    mipmurph@iupui.edu   
Contact: Janet Klein, RN    (317) 962-0287    jswklein@iupui.edu   
Sub-Investigator: Keith L March, MD,PhD         
Sponsors and Collaborators
Murphy, Michael P., MD
Indiana University School of Medicine
Investigators
Principal Investigator: Michael P Murphy, MD Indiana University School of Medicine