Methods
Primary objectives were to demonstrate feasibility and safety of ASM procurement and injection, focusing on ventricular arrhythmia...
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Conclusion
Our experience from this Phase 1 study indicates that catheter-based delivery of ASM is feasible and safe in pts with chronic SLVD...
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Bioheart Myoheart Dose Escalation U.S. Clinical Study Interim Results
Intramyocardial Myoblast Treatment for Ischemic Heart Failure: Results of a Phase I Study.
Warren Sherman, Nic Chronos, Stephen Ellis, Timothy Henry, David Holmes; Medicine, Columbia University Medical Center, New York, NY; Medicine, St. Joseph’s Medical Center, Atlanta GA; Stephen Ellis, Cleveland Clinic, Cleveland OH; Medicine, University of Minnesota, Minneapolis, MN; Medicine, University of Minnesota, Minneapolis, MN; Medicine Mayo Clinic, Rochester, MN
Background: Preliminary studies of autologous skeletal myoblast (ASM) implantation during CABG suggest improvement in clinical status and left ventricular (LV) function, with minimal potential risk. Dual interventions in these studies obscure effects attributable to ASM alone. We report the early results of a multicenter, Phase I study of ASM as the sole intervention, in patients with congestive heart failure (CHF).
Methods: MYOHEART is an open label, dose escalation study of intramyocardial ASM administration with an endovascular injection catheter. Patients with NYHA Class 2-3 CHF from post-MI systolic left ventricular dysfunction (SLVD), EF 20-40% without reversible myocardial ischemia were eligible. Primary objectives were to demonstrate feasibility and safety of ASM procurement and injection, focusing on ventricular arrhythmia. Secondary objectives assessed parameters of clinical condition and LV function. Results: As of 4/06, 15 subjects were implanted, 5 into each of three dose-groups: 25 x 106, 75 x 106 and 225 x 106.
Patient characteristics: age 55 + 8, CHF Class 2.6 + 0.2, DM 20%. There were no acute procedural-related adverse events. In follow-up (1-12 mo) 1 subject died (10 wks) of ischemic VF, 2 had brief runs of nonsustained VT (less than 10 bests), 1 had ICD shocks from rapid AF. CHF Class improved to 2.1 + 0.3 (p=ns) and EF: baseline 24 + 7.6 (n=10), 3 month 24 + 5.5 (n=7), 6 month 30 + 6.9 (n=6) (p=ns).
Conclusion: Our experience from this Phase 1 study indicates that catheter-based delivery of ASM is feasible and safe in pts with chronic SLVD. At 3-12 months, the incidence of adverse clinical events, including ventricular arrhythmias is not above that expected in pts with Class 2-3 CHF. A preliminary trend to improved clinical status and EF is suggested. 3-month data from all 15 subjects will be presented.
(Journal of Cardiac Failure volume 12, number 6, supplement 1 Aug. 2006, page S74 abstract 238. Distributed at HEART FAILURE SOCIETY OF AMERICA Annual Scientific Meeting Sept. 10-13, 2006 in Seattle, WA and duly presented at a poster session and at the Bioheart Scientific Exhibit).
Bioheart Myoheart Dose Escalation U.S. Clinical Study
Interim Results in Graph Form
