This is a phase 1, single-blind trial to evaluate using autologous bone marrow mononuclear stem cells in ischemic cardiomyopathy patients. The patients must have a LVEF of less than or equal to 45%. Once the patient meets all inclusion criteria, and no exclusion criteria are found, the subject is consented for the study, and extensive baseline testing is performed at St Luke's Hospital in Houston. Once all baseline testing criteria is met, the patient has their own bone marrow harvested and later that day the subject is taken to a cardiac catheterization lab where NOGA mapping is performed and the processed stem cells are injected under electromechanical guidance into the affected areas of the left ventricle. The patient is usually discharged home the next day and returns for follow up visits at weeks 1, 2, 4, 6, 8, 12, months 6 and 12 and for phone call follow-up at months 4, 5, 7, 8, 9, 10, 11. Patients undergo extensive testing at most of these follow-up visits, including repeat cardiac catheterization with NOGA mapping at month 6 after stem cell injection.
Primary Outcome Measures:
- Safety of autologous-bone-marrow injections in endstage ischemic cardiomyopathy patients [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To assess the efficacy of autologous bone marrow cells in improving cardiac contractile function and functional
outcome in endstage ischemic cardiomyopathy patients. The efficacy will be primarily assessed on the basis of the
treadmillMVO2 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Enrollment: |
30 |
| Study Start Date: |
April 2004 |
| Estimated Study Completion Date: |
September 2009 |
| Estimated Primary Completion Date: |
August 2009 (Final data collection date for primary outcome measure) |
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1: Experimental
Subject is randomized to receive sham treatment at the time of active enrollment and treatment.
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Device: Intramyocardial Injection of stem cells via Noga Mapping
NOGA mapping and injection used to deliver cells in the active arm of the protocol. Sham subjects only receive a NOGA mapping and no injections.
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This is a phase 1, single-blind trial to evaluate the use of autologous bone marrow mononuclear stem cells in ischemic cardiomyopathy patients. The study hypothesis is that transendocardial injections of autologous mononuclear bone marrow cells in patients with end-stage ischemic heart disease is safe, can promote neovascularization, and can improve perfusion and myocardial contractility. The primary object of this study will be to evaluate the safety of autologous-bone-marrow mononuclear cell injections .The secondary endpoint of the study is to assess the efficacy of autologous bone marrow cells in improving cardiac contractile function and functional outcome. THe efficacy will be assessed on the basis of the treadmill Max VO2. Secondarily the efficacy will be assessed on the basis of clinical status and imaging rests, with follow-up extending to 1 year after enrollment.A maximum of 30 patients will be enrolled in the study. At the end of the 6-month visit. after the required angiogram with mapping and non-invasive testing is complete, the patients will be told whether they were in the control or the active group. Those in the control group will be told before final invasive testing, and those who consent may cross over to the active therapy arm and undergo the cell injection procedure. In these patients, the foll-up angiogram and mapping procedure will also serve as the baseline procedure required for cell injection. Bonemarrow mononuclear cells will be injected in an identical fashion, according to the same criteria described for the original treatment group, and these patients will have identical follow-up visits starting again at the baseline time-point and extending for up to 1 year.
Purpose
