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Sponsored by: |
Aldagen |
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Information provided by: | Aldagen |
ClinicalTrials.gov Identifier: | NCT00392509 |
This study will treat patients with such severe lower leg ischemia or vascular compromise that they have pain at rest. The goal is to compare treatment of the patient's painful disorder by injecting cells into the calf of the leg and testing for circulatory improvement. A treatment will given at random to two groups and will be injection into the calf muscle with ALD-301 (specially processed stem and progenitor cells) from the patient's own bone marrow, or with cells processed by more routine that minimally purifies the cells. The study goal is to see if the ALD-301 cells are more effective in generating new small blood vessels to improve the circulation to the affected leg.
Condition | Intervention | Phase |
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Critical Limb Ischemia Peripheral Arterial Disease Peripheral Vascular Disease |
Procedure: ALDH-br bone marrow cells vs. mononuclear bone marrow cells |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase I-II Randomized Autologous Bone Marrow Derived Aldehyde Dehydrogenase-Bright (ALDHbr) Cells Against Unfractionated Autologous Mononuclear Bone Marrow in Patients With Rutherford 4 or 5 Peripheral Arterial Occlusive Disease |
Estimated Enrollment: | 20 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | October 2008 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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2: Experimental
Unfractionated Autologous Mononuclear Bone Marrow
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Procedure: ALDH-br bone marrow cells vs. mononuclear bone marrow cells
Surgery
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Patients will be recruited who have critical limb ischemia with pain at rest. The study will select patients for treatment and follow them for three months after intervention. The treatment will consist of drawing about 2/3 of a cup of bone marrow from the patient's hip bone, then processing the collected bone marrow will be as follows:
These cells will be injected into the calf muscle of the patient in clinic.
The patients will be monitored for adverse events related to this process to determine the safety of the approach. They will also be tested at intervals during the study to compare baseline values of each patient with the post-treatment values of:
The patients will receive a call at 6 months to report on additional life events following the study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Cardiovascular conditions:
Contact: Rachael Crozier, RN, MS | 919 484-2571 ext 260 | rcrozier@aldagen.com |
United States, Alabama | |
Cardiology PC | Recruiting |
Birmingham, Alabama, United States, 35211 | |
Contact: Susan DeRamus, RN 205-780-4330 ext 338 SDeramus@cardiologypc.com | |
Principal Investigator: Farrell Mendelsohn, MD | |
United States, Georgia | |
Saint Joseph's Research Institute | Recruiting |
Atlanta, Georgia, United States, 30342 | |
Contact: Nichelle Jackson, RN 404-843-6089 nljackson@sjha.org | |
Contact: Ioana Ghiu, MD, MS 404 843-6078 ighiu@sjha.org | |
Principal Investigator: Nicolas Chronos, MD | |
United States, Indiana | |
University of Indiana at Indianapolis | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Contact: Janet Klein, RN, MSN 317-962-0287 jswklein@iupui.edu | |
Principal Investigator: Michael Murphy, M.D. | |
United States, North Carolina | |
Duke University Medical Center | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: Kim McIntosh 919-681-5072 kim.mcintosh@duke.edu | |
Principal Investigator: Robert Mitchell, M.D. | |
United States, Texas | |
Texas Heart Institute, Stem Cell Center, 6770 Bertner, St Luke's Episcopal Hospital | Recruiting |
Houston,, Texas, United States, 77030 | |
Contact: Sandi Shaw, RN 832-355-9802 sshaw@heart.thi.tmc.edu | |
Contact: Deirdre Smith, RN 832 355-9801 dxsmith@heart.thi.tmc.edu | |
Principal Investigator: Emerson C Perin, M.D., Ph.D. |
Principal Investigator: | Emerson C Perin, M.D., Ph.D. | Stem Cell Center, Texas Heart Institute, St Luke's Episcopal Hospital, 6770 Bertner , Suite 1020 Texas Medical Center,Houston, Texas 77030 |
Principal Investigator: | Robert Mitchell, MD | Duke University |
Principal Investigator: | Michael Murphy, MD | University of Indiana at Indianapolis |
Principal Investigator: | Nicolas Chronos, MD | Saint Joseph's Research Institute |
Principal Investigator: | Farrell Mendelsohn, MD | Cardiology PC |
Responsible Party: | Aldagen, Inc. ( Laurence Keller, MD ) |
Study ID Numbers: | BB IND 12875 |
Study First Received: | October 25, 2006 |
Last Updated: | April 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00392509 History of Changes |
Health Authority: | United States: Food and Drug Administration |
critical limb ischemia cell therapy for angiogenesis aldehyde dehydrogenase-bright cells peripheral artery disease peripheral vascular disease leg pain |
PVD PAD CLI amputation limb salvage |
Arterial Occlusive Diseases Peripheral Vascular Diseases Vascular Diseases Pain Ischemia |
Arterial Occlusive Diseases Pathologic Processes Peripheral Vascular Diseases |
Vascular Diseases Cardiovascular Diseases Ischemia |