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Allogeneic Human Mesenchymal Stem Cell Infusions for Aging Frailty.

Allogeneic Human Mesenchymal Stem Cell Infusions for Aging Frailty.

Authors :
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 Jr
Green G
Premer C
Medina A
Valasaki K
Florea V
Anderson E
El-Khorazaty J
Mendizabal A
Goldschmidt-Clermont PJ
Hare JM
Source :
The journals of gerontology. Series A, Biological sciences and medical sciences [J Gerontol A Biol Sci Med Sci] 2017 Oct 12; Vol. 72 (11), pp. 1505-1512.
Publication Year :
2017

Abstract

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.<br />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.<br />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.<br />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.<br /> (© The Author 2017. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Details

Language :
English
ISSN :
1758-535X
Volume :
72
Issue :
11
Database :
MEDLINE
Journal :
The journals of gerontology. Series A, Biological sciences and medical sciences
Publication Type :
Academic Journal
Accession number :
28444181
Full Text :
https://doi.org/10.1093/gerona/glx056