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Cell Therapy in CV Disease: Future Directions. Cardiac renewal: Is the goal in sight?. “Remaining young at heart is a desirable but elusive goal. Myocyte regeneration may accomplish just that.
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Cardiac renewal: Is the goal in sight? “Remaining young at heart is a desirable but elusive goal. Myocyte regeneration may accomplish just that. Continuous cell renewal in adult myocardium was thought to be impossible; multipotent stem cells may be able to renew myocardium and, under certain circumstances, can be coaxed to repair the broken heart after infarction.” Anversa P, Nadal-Ginard B et al. Nature. 2002;415:240-3.
Stem cell therapy: More questions than answers? Timing of delivery Acute vs chronic Routes of delivery Surgical vs percutaneous ? Cell type and marker Myoblast vs BM CD 34/ AC133/ SP Target patient population Best criteria Cell origin Embryonic vs adult BM vs peripheral Culture expanded vs fresh Dose Dose response Courtesy of Timothy Henry, MD.
CCTRN: Addressing gaps in the knowledge base NHLBI Cardiovascular Cell Therapy Research Network, established January 2007 Universityof Florida MHIU of Minn VanderbiltUniversity Network DCC Universityof Texas Texas Heart Institute ClevelandClinic DCC = Data Coordinating CenterMHI = Minneapolis Heart Institute Nat Clin Pract Cardiovasc Med. 2007;4:403.
CCTRN: Goal and initial phase I/II clinical trials Goal:Accelerate research into use of cell-based therapies in management of CV diseases TIME Effect of timing of post-MI BMC administration on measures of LV function Late TIME Effect of late (2-3 weeks) post-MI BMC administration on measures of LV function FOCUS Effect of transmyocardial BMC administration on measures of LV function in patients with chronic IHD Nat Clin Pract Cardiovasc Med. 2007;4:403.
CCTRN: Timeline of trials Year 01 Year 02 Year 03 Year 04 Year 05 Protocol 1 Development PRC DSMB Review Protocol 1 Protocol 2 Development PRC DSMB Review Protocol 2 Protocol 3 Development PRC DSMB Review Protocol 3 Courtesy Timothy Henry, MD.
Summary • Current clinical efforts have focused in three overlapping areas: • Repair of myocardium after MI • Reconstitution of myocardium in setting of chronic HF • Therapeutic angiogenesis • Promising early clinical experience with BMC, endothelial cells, and skeletal myoblasts • Numerous questions regarding techniques and mechanism of benefit remain • Ongoing trials by the NHLBI CCTRN and other research groups should provide insight