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
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Vascular Diseases||Drug: adult stem cells||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
- Adverse events recorded in the 12 week study period
- Serious Adverse events recorded for one year
- Changes in limb perfusion after treatment with stem cells will be assessed with arteriography, blood pressure recordings, oxygen measurements, and wound healing
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
|Contact: Michael P Murphy, MD||(317) firstname.lastname@example.org|
|Contact: Julie Lacy, RN||(317)email@example.com|
|United States, Indiana|
|Indiana University School of Medicine||Recruiting|
|Indianapolis, Indiana, United States, 46202|
|Contact: Michael P Murphy, MD 317-630-8288 firstname.lastname@example.org|
|Contact: Janet Klein, RN (317) 962-0287 email@example.com|
|Sub-Investigator: Keith L March, MD,PhD|
|Principal Investigator:||Michael P Murphy, MD||Indiana University School of Medicine|