Bonig, Halvard, Kuçi, Zyrafete, Kuçi, Selim, Bakhtiar, Shahrzad, Basu, Oliver, Bug, Gesine, Dennis, Mike, Greil, Johann, Barta, Aniko, Kállay, Krisztián M, Lang, Peter, Lucchini, Giovanna, Pol, Raj, Schulz, Ansgar, Sykora, Karl-Walter, Teichert von Luettichau, Irene, Herter-Sprie, Grit, Ashab Uddin, Mohammad, Jenkin, Phil, Alsultan, Abdulrahman, Buechner, Jochen, Stein, Jerry, Kelemen, Agnes, Jarisch, Andrea, Soerensen, Jan, Salzmann-Manrique, Emilia, Hutter, Martin, Schäfer, Richard, Seifried, Erhard, Paneesha, Shankara, Novitzky-Basso, Igor, Gefen, Aharon, Nevo, Neta, Beutel, Gernot, Schlegel, Paul-Gerhardt, Klingebiel, Thomas and Bader, Peter (2019) 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, 8 (12). ISSN 2073-4409. This article is available to all UHB staff and students via ASK Discovery tool http://tinyurl.com/z795c8c by using their UHB Athens login IDs
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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 ≥°III, one-third only steroid-refractory and two-thirds therapy resistant (refractory to steroids plus ≥2 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.
Item Type: | Article |
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Additional Information: | This article is available to all UHB staff and students via ASK Discovery tool http://tinyurl.com/z795c8c by using their UHB Athens login IDs |
Subjects: | QU Biochemistry QW Microbiology. Immunology WH Haemic and lymphatic systems. Haematology |
Divisions: | Planned IP Care > Oncology and Clinical Haematology |
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Depositing User: | Jamie Edgar |
Date Deposited: | 13 Dec 2019 13:55 |
Last Modified: | 13 Dec 2019 13:55 |
URI: | http://www.repository.uhblibrary.co.uk/id/eprint/2684 |
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