Yazarlar : Introna M, Lucchini G, Dander E, et al

Yayın : Biol Blood Marrow Transplant.

Yayın Yılı : 2013

Pubmed Linki : http://www.ncbi.nlm.nih.gov/m/pubmed/24321746/

Konu : Kemik İliği Nakli

Literatür İçeriği :  

Abstract

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 (PL) in 40 patients (15 children, 25 adults), experiencing steroid-resistant grade II-IV GvHD. Patients received a median of 3 MSC infusions after having failed conventional immunosuppressive therapy. A median cell dose of 1.5 x 10(6)/kg per infusion was administered. No acute toxicity was reported. Overall, 86 AE and SAE were reported in the study, most of which (72.1%) of infectious nature. Overall response rate, measured at 28 days following 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 to higher grades (61.5% versus 11.1%, p=0.002), and was borderline significant in children as compared to adults (46.7 vs 16.0%, p=0.065). 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.

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