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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
Bonig, H Kuci, Z Kuci, S Bakhtiar, S Basu, O Bug, G Dennis, Michael Greil, J Barta, A Kallay, KM
Bonig, H
Kuci, Z
Kuci, S
Bakhtiar, S
Basu, O
Bug, G
Dennis, Michael
Greil, J
Barta, A
Kallay, KM
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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.
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
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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Date
2019
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Article
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.