Allogeneic Bone Marrow-Derived Mesenchymal Stromal Cells Expanded In Vitro for Treatment of Aplastic Anemia: A Multicenter Phase II Trial

Stem Cells Translational Medicine
Yan PangYang Xiao

Abstract

We conducted a phase II, noncomparative, multicenter study to assess the efficacy and safety of allogeneic bone marrow-derived mesenchymal stromal cells (BM-MSCs) expanded in vitro for patients with aplastic anemia (AA) refractory to immunosuppressive therapy. Seventy-four patients from seven centers received allogeneic BM-MSCs at a dose of 1-2 × 106 cells/kg per week for 4 weeks. Responses were assessed at 0.5, 1, 2, 3, 6, 9, and 12 months after the first cells infusion. Patients with response at 1 month continued to receive four infusions. All patients were evaluable. The overall response rate was 28.4% (95% confidence interval, 19%-40%), with 6.8% complete response and 21.6% partial response. The median times to response of leukocytic, erythrocytic, and megakaryocytic linages were 19 (range, 11-29), 17 (range, 12-25), and 31 (range, 26-84) days, respectively. After median follow-up of 17 months, overall survival was 87.8%. Seven patients developed transitory and mild headache and fever, but no other adverse events were observed. Antithymocyte globulin used in previous treatment and no activated infection throughout treatment were predictors for response. Allogeneic BM-MSCs infusion is a feasible and effective treatment optio...Continue Reading

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Citations

May 3, 2018·Journal of Cellular Physiology·Sadegh L MoradiAbdolreza Ardeshirylajimi
Jan 16, 2018·Stem Cells International·Vivian Fonseca GonzagaIrina Kerkis
Jan 13, 2018·World Journal of Stem Cells·Larisa BroglieJeffrey A Medin
Dec 21, 2018·Frontiers in Oncology·Michael MedingerJakob Passweg
Aug 5, 2020·International Journal of Hematology·Lei YeSeiji Kojima

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Methods Mentioned

BETA
biopsy

Clinical Trials Mentioned

NCT00195624

Software Mentioned

SPSS
STATA

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