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    Children and adults with refractory acute graft-versus-host disease respond to treatment with the mesenchymal stromal cell preparation 'MSC-FFM'-outcome report of 92 patients

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    Authors
    Bonig, H
    Kuci, Z
    Kuci, S
    Bakhtiar, S
    Basu, O
    Bug, G
    Dennis, Michael
    Greil, J
    Barta, A
    Kallay, KM
    Lang, P
    Lucchini, G
    Pol, R
    Schulz, A
    Sykora, KW
    Teichert von Luettichau, I
    Herter-Sprie, G
    Ashab, Uddin M
    Jenkin, P
    Alsultan, A
    Buechner, J
    Stein, J
    Kelemen, A
    Jarisch, A
    Soerensen, J
    Salzmann-Manrique, E
    Hutter, M
    Schafer, R
    Seifried, E
    Paneesha, S
    Novitzky-Basso, I
    Gefen, A
    Nevo, N
    Beutel, G
    Schlegel, PG
    Klingebiel, T
    Bader, P
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    Affiliation
    Goethe University Medical Center, Institute of Transfusion Medicine and Immunohematology, and German Red Cross Blood Center Frankfurt, Frankfurt am Main, 60528 Frankfurt
    Issue Date
    2019
    
    Metadata
    Show full item record
    Abstract
    (1) Background: Refractory acute graft-versus-host disease (R-aGvHD) remains a leading cause of death after allogeneic stem cell transplantation. Survival rates of 15% after four years are currently achieved; deaths are only in part due to aGvHD itself, but mostly due to adverse effects of R-aGvHD treatment with immunosuppressive agents as these predispose patients to opportunistic infections and loss of graft-versus-leukemia surveillance resulting in relapse. Mesenchymal stromal cells (MSC) from different tissues and those generated by various protocols have been proposed as a remedy for R-aGvHD but the enthusiasm raised by initial reports has not been ubiquitously reproduced. (2) Methods: We previously reported on a unique MSC product, which was generated from pooled bone marrow mononuclear cells of multiple third-party donors. The products showed dose-to-dose equipotency and greater immunosuppressive capacity than individually expanded MSCs from the same donors. This product, MSC-FFM, has entered clinical routine in Germany where it is licensed with a national hospital exemption authorization. We previously reported satisfying initial clinical outcomes, which we are now updating. The data were collected in our post-approval pharmacovigilance program, i.e., this is not a clinical study and the data is high-level and non-monitored. (3) Results: Follow-up for 92 recipients of MSC-FFM was reported, 88 with GvHD ³¡III, one-third only steroid-refractory and two-thirds therapy resistant (refractory to steroids plus ³2 additional lines of treatment). A median of three doses of MSC-FFM was administered without apparent toxicity. Overall response rates were 82% and 81% at the first and last evaluation, respectively. At six months, the estimated overall survival was 64%, while the cumulative incidence of death from underlying disease was 3%. (4) Conclusions: MSC-FFM promises to be a safe and efficient treatment for severe R-aGvHD.
    Citation
    Bonig H, Kuci Z, Kuci S, Bakhtiar S, Basu O, Bug G, et al. Children and Adults with Refractory Acute Graft-versus-Host Disease Respond to Treatment with the Mesenchymal Stromal Cell Preparation "MSC-FFM"-Outcome Report of 92 Patients. Cells. 2019;8(12):e1577.
    Journal
    Cells
    URI
    http://hdl.handle.net/10541/622667
    DOI
    10.3390/cells8121577
    PubMed ID
    31817480
    Additional Links
    https://dx.doi.org/10.3390/cells8121577
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.3390/cells8121577
    Scopus Count
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