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Allogeneic Human Mesenchymal Stem Cell Infusions for Aging Frailty #MMPMID28444181
Golpanian S; DiFede DL; Khan A; Schulman IH; Landin AM; Tompkins BA; Heldman AW; Miki R; Goldstein BJ; Mushtaq M; Levis-Dusseau S; Byrnes JJ; Lowery M; Natsumeda M; Delgado C; Saltzman R; Vidro-Casiano M; Pujol MV; Da Fonseca M; Oliva AA; Green G; Premer C; Medina A; Valasaki K; Florea V; Anderson E; El-Khorazaty J; Mendizabal A; Goldschmidt-Clermont PJ; Hare JM
J Gerontol A Biol Sci Med Sci 2017[Oct]; 72 (11): 1505-12 PMID28444181show ga
Background: Impaired endogenous stem cell repair capacity is hypothesized to be a biologic basis of frailty. Therapies that restore regenerative capacity may therefore be beneficial. This Phase 1 study evaluated the safety and potential efficacy of intravenous, allogeneic, human mesenchymal stem cell (allo-hMSC)-based therapy in patients with aging frailty. Methods: In this nonrandomized, dose-escalation study, patients received a single intravenous infusion of allo-hMSCs: 20-million (n = 5), 100-million (n = 5), or 200-million cells (n = 5). The primary endpoint was incidence of any treatment-emergent serious adverse events measured at 1 month postinfusion. The secondary endpoints were functional efficacy domains and inflammatory biomarkers, measured at 3 and 6 months, respectively. Results: There were no treatment-emergent serious adverse events at 1-month postinfusion or significant donor-specific immune reactions during the first 6 months. There was one death at 258 days postinfusion in the 200-million group. In all treatment groups, 6-minute walk distance increased at 3 months (p = .02) and 6 months (p = .001) and TNF-? levels decreased at 6 months (p < .0001). Overall, the 100-million dose showed the best improvement in all parameters, with the exception of TNF-?, which showed an improvement in both the 100- and 200-million groups (p = .0001 and p = .0001, respectively). The 100-million cell-dose group also showed significant improvements in the physical component of the SF-36 quality of life assessment at all time points relative to baseline. Conclusions: Allo-hMSCs are safe and immunologically tolerated in aging frailty patients. Improvements in functional and immunologic status suggest that ongoing clinical development of cell-based therapy is warranted for frailty.
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J+Gerontol+A+Biol+Sci+Med+Sci 2017 ; 72 (11): 1505-12
