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| Sponsor: | Losordo, Douglas, M.D. |
|---|---|
| Information provided by: | Losordo, Douglas, M.D. |
| ClinicalTrials.gov Identifier: | NCT00620048 |
Purpose
The purpose of this study is to determine if cell therapy with your own cells (autologous cells) delivered with a catheter to regions of the heart with poor blood flow will be safe and if it will improve your ejection fraction and heart failure symptoms.
| Condition | Intervention | Phase |
|---|---|---|
|
Myocardial Ischemia Congestive Heart Failure Cardiovascular Disease |
Biological: Autologous Stem Cells |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Injection of Autologous CD34+ Cells for Neovascularization and Symptom Relief in Patients With Myocardial Ischemia and LVEF < 40% |
| Estimated Enrollment: | 10 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | August 2009 |
| Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 21 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Illinois | |
| Northwestern University | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Rita Vargos, RN 312-695-0006 rvargos@northwestern.edu | |
| Contact: Sherrie Wolfe, RN, CCRC 312-926-3413 s-wolfe@northwestern.edu | |
| Principal Investigator: Douglas W Losordo, MD | |
| Principal Investigator: | Douglas W. Losordo, M.D. | Northwestern University |
More Information
| Responsible Party: | Northwestern University/Northwestern Memorial Hospital ( Director, Feinberg Cardiovascular Research Institute, Program in Cardiovascular Regenerative Medicine ) |
| Study ID Numbers: | 11196-03 |
| Study First Received: | February 7, 2008 |
| Last Updated: | June 18, 2009 |
| ClinicalTrials.gov Identifier: | NCT00620048 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
heart stem Cells low EF heart attack cardiomyopathy |
congestive heart failure cardiovascular disease Heart Failure Low Ejection Fraction |
|
Heart Failure Pathologic Processes Heart Diseases Myocardial Ischemia |
Vascular Diseases Cardiovascular Diseases Ischemia |