Allogeneic Human Mesenchymal Stem Cell Infusions for Aging Frailty

Samuel Golpanian, Darcy L. Difede, Aisha Khan, Ivonne Hernandez Schulman, Ana Marie Landin, Bryon A. Tompkins, Alan W. Heldman, Roberto Miki, Bradley J. Goldstein, Muzammil Mushtaq, Silvina Levis-Dusseau, John J. Byrnes, Maureen Lowery, Makoto Natsumeda, Cindy Delgado, Russell Saltzman, Mayra Vidro-Casiano, Marietsy V. Pujol, Moisaniel Da Fonseca, Anthony A. OlivaGeoff Green, Courtney Premer, Audrey Medina, Krystalenia Valasaki, Victoria Florea, Erica Anderson, Jill El-Khorazaty, Adam Mendizabal, Pascal J. Goldschmidt-Clermont, Joshua M. Hare

Research output: Contribution to journalArticlepeer-review

31 Scopus citations


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-α levels decreased at 6 months (p <.0001). Overall, the 100-million dose showed the best improvement in all parameters, with the exception of TNF-α, 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.

Original languageEnglish (US)
Pages (from-to)1505-1512
Number of pages8
JournalJournals of Gerontology - Series A Biological Sciences and Medical Sciences
Issue number11
StatePublished - Nov 1 2017


  • Cell-based therapy
  • Inflammation
  • Physical function
  • Regenerative medicine

ASJC Scopus subject areas

  • Aging
  • Geriatrics and Gerontology


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