Working… Menu

Safety Study of Using Stem Cells to Stimulate Development of New Blood Vessels in Peripheral Vascular 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. 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
Indiana University School of Medicine
Information provided by:
Murphy, Michael P., MD

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00113243

Layout table for location contacts
Contact: Michael P Murphy, MD (317) 630-8288
Contact: Julie Lacy, RN (317)962-0138

Layout table for location information
United States, Indiana
Indiana University School of Medicine Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Michael P Murphy, MD    317-630-8288   
Contact: Janet Klein, RN    (317) 962-0287   
Sub-Investigator: Keith L March, MD,PhD         
Sponsors and Collaborators
Murphy, Michael P., MD
Indiana University School of Medicine
Layout table for investigator information
Principal Investigator: Michael P Murphy, MD Indiana University School of Medicine
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00113243    
Other Study ID Numbers: IUPUI 0503-14
First Posted: June 7, 2005    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: June 2005
Additional relevant MeSH terms:
Layout table for MeSH terms
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Arterial Occlusive Diseases