Intramuscular implantation of cultured allogeneic myoblasts derived from pathogen-free muscle biopsies of genetically normal human volunteers demonstrated safety and efficacy in clinical studies of Duchenne muscular dystrophy (DMD), heart failure, ischemic cardiomyopathy, Type-II diabetes, cancer, and aging disfigurement. Through natural cell fusion, donor myoblasts inserted their normal nuclei that supplied the complete human genome to replenish the aberrant gene(s). The replacement gene(s) produced single or multiple gene transcripts, factors, and protein(s) in multiple pathways to effect complementary genetic repair. Donor myoblasts also fused among themselves to form normal myofibers. Applications included diagnostic screening, disease prevention, disease treatment, drug discovery, and selection of superior cell clones for therapies. Only 3-week cyclosporine immunosuppression was necessary to support engraftment, development, and functioning. Improvement in the host included production of repairing structural and regulatory proteins, increases in muscle cell number and function, increases in locomotive capacity, breathing capacity and life span in DMD boys, increases in blood ejection and vascularization in heart failure and ischemic patients, and transfer of biochemicals and ions across the muscle cell membrane in diabetic patients. Intra-tumor implantation of allogeneic human myoblasts induced cancer apoptosis, inhibiting metastasis and tumor growth with cancer patients. FDA currently listed 23 myoblast implantation projects, and EMA listed 6, mostly in Phase II with some in Phase III clinical trials. This unique platform technology, patented for its compositions, methods, and related medical devices of cell/gene therapies, promised to be of great social and economic values in world health and human services.
Intramuscular implantation of cultured allogeneic myoblasts derived from pathogen-free muscle biopsies of genetically normal human volunteers demonstrated safety and efficacy in clinical studies of Duchenne muscular dystrophy (DMD), heart failure, ischemic cardiomyopathy, Type-II diabetes, cancer, and aging disfigurement. Through natural cell fusion, donor myoblasts inserted their normal nuclei that supplied the complete human genome to replenish the aberrant gene(s). The replacement gene(s) produced single or multiple gene transcripts, factors, and protein(s) in multiple pathways to effect complementary genetic repair. Donor myoblasts also fused among themselves to form normal myofibers. Applications included diagnostic screening, disease prevention, disease treatment, drug discovery, and selection of superior cell clones for therapies. Only 3-week cyclosporine immunosuppression was necessary to support engraftment, development, and functioning. Improvement in the host included production of repairing structural and regulatory proteins, increases in muscle cell number and function, increases in locomotive capacity, breathing capacity and life span in DMD boys, increases in blood ejection and vascularization in heart failure and ischemic patients, and transfer of biochemicals and ions across the muscle cell membrane in diabetic patients. Intra-tumor implantation of allogeneic human myoblasts induced cancer apoptosis, inhibiting metastasis and tumor growth with cancer patients. FDA currently listed 23 myoblast implantation projects, and EMA listed 6, mostly in Phase II with some in Phase III clinical trials. This unique platform technology, patented for its compositions, methods, and related medical devices of cell/gene therapies, promised to be of great social and economic values in world health and human services.
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