Treatment of Graft versus Host Disease with Mesenchymal Stromal Cells: A Phase I Study on 40 Adult and Pediatric Patients

Autor: Francesca Masciocchi, Attilio Rovelli, Giovanna D'Amico, Sergio Cortelazzo, Adriana Balduzzi, Anna Grassi, Ettore Biagi, Martino Introna, Olga Pedrini, Giovanna Lucchini, Paolo Perseghin, Andrea Biondi, Giuseppe Gaipa, Daniela Longoni, Chiara Capelli, Stefania Galimberti, Erica Dander, Enrico Maria Pogliani, Fabio Pavan, Irene Cavattoni, Matteo Parma, Sara Deola, Josée Golay, Alessandra Algarotti, Daniela Belotti, Caterina Micò, Alessandro Rambaldi
Přispěvatelé: Introna, M, Lucchini, G, Dander, E, Galimberti, S, Rovelli, A, Balduzzi, A, Longoni, D, Pavan, F, Masciocchi, F, Algarotti, A, Micò, C, Grassi, A, Deola, S, Cavattoni, I, Gaipa, G, Belotti, D, Perseghin, P, Parma, M, Pogliani, E, Golay, J, Pedrini, O, Capelli, C, Cortelazzo, S, D'Amico, G, Biondi, A, Rambaldi, A, Biagi, E
Rok vydání: 2014
Předmět:
Adult
Male
medicine.medical_specialty
Adolescent
medicine.medical_treatment
Mesenchymal stromal cells
Graft vs Host Disease
Antineoplastic Agents
Disease
Mesenchymal Stem Cell Transplantation
Severity of Illness Index
Gastroenterology
Steroid refractory graft-versus-host disease (GVHD)
Cell therapy
Internal medicine
medicine
Humans
Transplantation
Homologous
Child
Adverse effect
Aged
Transplantation
Mesenchymal stromal cell
business.industry
Remission Induction
Mesenchymal stem cell
Infant
Immunosuppression
Hematology
Middle Aged
medicine.disease
Survival Analysis
Acute toxicity
Immunosuppressive treatment
Surgery
Graft-versus-host disease
Drug Resistance
Neoplasm
Child
Preschool
Hematologic Neoplasms
Hematopoietic stem cell transplantation (HSCT)
Female
Steroids
Platelet lysate
business
Immunosuppressive Agents
Zdroj: Biology of Blood and Marrow Transplantation. 20:375-381
ISSN: 1083-8791
DOI: 10.1016/j.bbmt.2013.11.033
Popis: This phase I multicenter study was aimed at assessing the feasibility and safety of intravenous administration of third party bone marrow–derived mesenchymal stromal cells (MSC) expanded in platelet lysate in 40 patients (15 children and 25 adults), experiencing steroid-resistant grade II to IV graft-versus-host disease (GVHD). Patients received a median of 3 MSC infusions after having failed conventional immunosuppressive therapy. A median cell dose of 1.5 × 106/kg per infusion was administered. No acute toxicity was reported. Overall, 86 adverse events and serious adverse events were reported in the study, most of which (72.1%) were of infectious nature. Overall response rate, measured at 28 days after the last MSC injection, was 67.5%, with 27.5% complete response. The latter was significantly more frequent in patients exhibiting grade II GVHD as compared with higher grades (61.5% versus 11.1%, P = .002) and was borderline significant in children as compared with adults (46.7 versus 16.0%, P = .065). Overall survival at 1 and 2 years from the first MSC administration was 50.0% and 38.6%, with a median survival time of 1.1 years. In conclusion, MSC can be safely administered on top of conventional immunosuppression for steroid resistant GVHD treatment. Eudract Number 2008-007869-23, NCT01764100.
Databáze: OpenAIRE
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