There are two targeted stem cell products. USRM currently has in development for the repair of cardiac tissue: MyoCellR and MyoCell SVF-1TM— both of which are poised to go to the next phase of clinical development.

MyoCellR, a muscle stem cell therapy intended to improve cardiac function after heart attack, involves utilizing USRM’s proprietary cell-culturing process to isolate and expand muscle stem cells (myoblasts) to assist in combating scar tissue in order to improve cardiac function. Phase I, II and part one of a phase II/III trial have been completed; Part two of a Phase II/III is approved by the FDA and ready to begin patient enrollment.

MyoCell SDF-1, a more robust form of MyoCellR, involves using the same myoblast cells as in MyoCellR with the addition of a gene-modified adenovirus vector in order to release additional stromal derived factor 1, or SDF-1 protein. By modifying the myoblasts to express SDF-1 prior to injection, the levels of SDF proteins in the heart can increase. In preclinical studies, MyoCell SDF-1 provided a 54% improvement of cardiac function compared to a 27% improvement in the original MyoCell composition while the animal placebo control group declined 10%. Preclinical trials also demonstrated MyoCell SDF-1 has the potential to enhance blood vessel formation in damaged hearts. The IND application was approved by the FDA.

USRM is currently seeking partners to fully develop and commercialize these products, which have already demonstrated safety and efficacy in preliminary studies.

U.S. Stem Cell also has a product line that is a derivatives of its core work in humans: veterinary stem cell products, which have demonstrated marketability in the high-end equine market.

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