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Sponsors and Collaborators: |
Amit, Patel N, M.D. University of Pittsburgh |
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Information provided by: | Amit, Patel N, M.D. |
ClinicalTrials.gov Identifier: | NCT00130377 |
This research study is being performed to find out more information about the safety of injecting bone marrow (from one's own hip bone) progenitor cells (BMPCs) into one's heart muscle. The study may also determine the optimal dose of BMPCs for congestive heart failure. The BMPCs are the cells from which the different types of blood and other cells grow. In patients with heart failure, the heart muscle does not pump well. Over a period of years, this continues to get worse until the patient dies of heart failure. The researchers are trying to find out if the injection of these BMPCs can make a change in the functioning of these areas of the heart muscle. Data from studies around the world have suggested that when patients with heart failure receive these cells by direct injection into their hearts they show signs of recovered heart function; however, there has been no evidence from actual studies of the cells of the patient’s hearts to show how this process works. It is the researcher's plan to inject either plain serum (the liquid part of the blood that does not contain any blood cells) or cells from the participant's own bone marrow (BMPCs) into his or her heart during one's coronary artery bypass grafting operation (CABG) and then to study the function of the heart. The researchers are trying to find out if the injection of these BMPCs into the damaged areas of the heart muscle can improve the functioning of these areas. The Food and Drug Administration (FDA) has approved enrollment of patients into Phase I of this study (a Phase I trial is a research study using techniques, or products for the first time in human subjects).
Condition | Intervention | Phase |
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Heart Failure, Congestive |
Procedure: Injection of Bone Marrow Progenitor Cells into the Heart |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety Study |
Official Title: | Phase 1 Study: Autologous Bone Marrow Progenitor Cell Treatment for Patients With Congestive Heart Failure Undergoing CABG Surgery |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Amit N. Patel, MD, MS | 412-648-6411 | patelan@upmc.edu |
Contact: Lynette Beattie, BSN | 412-648-6411 | beattieln@upmc.edu |
United States, Pennsylvania | |
University of Pittsburgh Medical Center | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Contact: Amit N. Patel, MD, MS 412-648-6411 patelan@upmc.edu | |
Principal Investigator: Amit N. Patel, MD, MS |
Principal Investigator: | Amit N. Patel, MD, MS | University of Pittsburgh |
Study ID Numbers: | 0506137 |
Study First Received: | August 12, 2005 |
Last Updated: | September 6, 2006 |
ClinicalTrials.gov Identifier: | NCT00130377 |
Health Authority: | United States: Food and Drug Administration |
Stem Cell Heart Failure Bone Marrow |
Heart Failure Heart Diseases |
Cardiovascular Diseases |