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Research Documents Scalable Production, Survival Following,Engraftment and Positive Impact on Cardiac Function in Infarcted,Rats for Geron's Human Embryonic Stem Cell-Based Therapeutic for,Heart Failure

Cardiomyocytes for the Treatment of Heart Failure

The results of work performed in collaboration with Drs. Charles Murry and Michael Laflamme at the University of Washington were presented by Dr. Joseph Gold, Geron's director of stem cell biology. The presentation described efficient differentiation of cardiomyocytes from hESCs and their effectiveness in preventing the onset of heart failure in rodent infarct models. In the differentiation procedure, cardiomyocytes were generated using non-conditioned, serum-free media and a directed differentiation protocol that produces cells with the phenotypic, electrophysiological and contractile properties of human immature cardiomyocytes. The new protocol produces cardiomyocytes with high efficiency, yielding 10-100 fold more cardiomyocytes per undifferentiated hESC than conventional "embryoid body-based" protocols. The differentiation protocol produced cardiomyocyte populations of up to 70% purity at scales sufficient to enable both preclinical and early clinical development. Moreover, the final cardiomyocyte product could be cryopreserved and thawed with high viability.

When transplanted together with survival enhancement factors directly into the myocardial infarct zone of rats, the GRNCM1 cells survived for at least four weeks and formed grafts expressing key markers of human cardiomyocytes, including Beta myosin heavy chain. Echocardiographic and magnetic resonance imaging analysis showed that the animals transplanted with GRNCM1 cells had improved (smaller) end-left ventricular systolic and diastolic diameters, increased fractional shortening, improved infarct wall thickening and increased ejection fraction compared to control animals injected with factors alone or controls injected with non-cardiac cells derived from hESCs. These data show that engrafted GRNCM1 cells significantly improved heart function after myocardial infarction.

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