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Mesenchymal stem cells expanded in vitro with human serum for the treatment of acute and chronic graft-versus-host disease: results of a phase I/II clinical trial
(Ferrata Storti Foundation, 2011-07) Cañizo, C. (C.) del; Martinez, C. (Carmen); Perez-Simon, J.A. (José Antonio); Diez-Campelo, M. (M.); Rifon, J. J. (Jose J.); Andreu, E.J. (Enrique José); Valcarcel, D. (David); Muntion, S. (Sandra); Lopez-Villar, O. (Olga); Sanchez-Guijo, F.M. (Fermín M.)
This trial evaluated the feasibility and efficacy of the infusion of mesenchymal stem cells expanded using human serum for the treatment of refractory acute or chronic graft-versus-host disease. Twenty-eight expansions were started. In 22, a minimum of more than 1 x 10⁶ mesenchymal stem cells/kg were obtained after a median of 26 days; this threshold was not obtained in the remaining cases. Ten patients received cells for the treatment of refractory or relapsed acute graft-versus-host disease and 8 for chronic disease. One patient treated for acute graft-versus-host disease obtained a complete response, 6 had a partial response and 3 did not respond. One of the chronic patients achieved complete remision, 3 a partial response, and 4 did not respond. The current study supports the use of this approach in less heavily treated patients for both acute and chronic graft-versus-host disease. The trial has been registered at ClinicalTrials.gov: identifier NCT00447460.