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Sponsored by: |
Northwestern University |
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Information provided by: | Northwestern University |
ClinicalTrials.gov Identifier: | NCT00278603 |
Severe peripheral vascular disease of the legs causes narrowing of the blood vessels in the legs, which keeps the blood from flowing adequately through these vessels. This study is designed to examine whether treating patients with their own previously collected blood stem cells will improve blood flow in the most severely affected leg. Blood stem cells are undeveloped cells that have the capacity to grow into mature blood cells, which normally circulate in the blood stream.
Condition | Intervention | Phase |
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Peripheral Vascular Disease |
Procedure: Stem Cell Transplantation |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Hematopoietic Stem Cell Injection for Peripheral Vascular Disease: Induction of Neoangiogenesis. A Phase I Study. |
Estimated Enrollment: | 12 |
Study Start Date: | October 2004 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
-Atherosclerotic ischemic peripheral vascular disease with rest pain defined as pain that occurs at night or at rest that involves the foot and is a sign of end stage vascular disease and / or ischemic lower extremity ulcers due to infra-inguinal disease and/or peak walking time of 1 to 6 minutes on two exercise tests separated by 2 weeks on graded treadmill.
Either a or b
Doppler waveforms at posterior tibial artery and dorsalis pedis artery are monophasic with toe pressure < 30 mmHg.
Exclusion Criteria:
United States, Illinois | |
Northwestern University, Feinberg School of Medicine | |
Chicago, Illinois, United States, 60611 |
Principal Investigator: | Richard Burt, MD | Northwestern University |
Responsible Party: | Northwestern University ( Richard Burt, MD ) |
Study ID Numbers: | PVD.HSCT2003 |
Study First Received: | January 15, 2006 |
Last Updated: | November 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00278603 |
Health Authority: | United States: Food and Drug Administration |
Peripheral Vascular Diseases Vascular Diseases Neovascularization, Pathologic |
Cardiovascular Diseases |