The FDA has granted IPS HEART Orphan Drug Designation (ODD) for GIVI-MPCs because of its exceptional capacity to produce new muscle with full length dystrophin in patients with Becker Muscular Dystrophy (BMD).
It has now been demonstrated by IPS HEART that GIVI-MPCs produce new human muscle with full length human dystrophin in a mouse model of sarcopenia, juvenile and very old Duchenne Muscular Dystrophy (DMD) mice, and dystrophic pigs. In order to demonstrate GIVI-MPCs’ exceptional platform potential to reverse debilitating diseases, the FDA previously granted GIVI-MPCs Orphan Drug Designation for DMD.
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