Halvard-Björn Bönig, Zyrafete Kuçi, Selim Kuçi, Shahrzad Bakhtiar, Oliver Basu, Gesine Bug, Mike Dennis, Johann Greil, Aniko Barta, Krisztián Kállay, Peter Lang, Giovanna Lucchini, Raj Pol, Ansgar Schulz, Karl-Walter Sykora, Irene Teichert- von Lüttichau, Grit Herter-Sprie, Mohammad Ashab Uddin, Phil Jenkin, Abdulrahman Alsultan, Jochen Büchner, Jerry Stein, Agnes Kelemen, Andrea Jarisch, Jan Sörensen, Emilia Salzmann-Manrique, Martin Hutter, Richard Schäfer, Erhard Seifried, Shankara Paneesha, Igor Novitzky-Basso, Aharon Gefen, Neta Nevo, Gernot Beutel, Paul-Gerhardt Schlegel, Thomas Klingebiel, Peter Bader
- (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.
MetadatenAuthor: | Halvard-Björn BönigORCiDGND, Zyrafete KuçiGND, Selim KuçiORCiDGND, Shahrzad BakhtiarGND, Oliver Basu, Gesine BugORCiDGND, Mike Dennis, Johann Greil, Aniko Barta, Krisztián KállayORCiD, Peter Lang, Giovanna Lucchini, Raj Pol, Ansgar SchulzORCiDGND, Karl-Walter Sykora, Irene Teichert- von Lüttichau, Grit Herter-Sprie, Mohammad Ashab Uddin, Phil Jenkin, Abdulrahman AlsultanORCiD, Jochen Büchner, Jerry Stein, Agnes Kelemen, Andrea JarischORCiDGND, Jan SörensenGND, Emilia Salzmann-Manrique, Martin Hutter, Richard SchäferORCiDGND, Erhard SeifriedORCiDGND, Shankara Paneesha, Igor Novitzky-Basso, Aharon Gefen, Neta Nevo, Gernot Beutel, Paul-Gerhardt SchlegelGND, Thomas KlingebielORCiDGND, Peter BaderORCiDGND |
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URN: | urn:nbn:de:hebis:30:3-527539 |
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DOI: | https://doi.org/10.3390/cells8121577 |
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ISSN: | 2073-4409 |
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Pubmed Id: | https://pubmed.ncbi.nlm.nih.gov/31817480 |
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Parent Title (English): | Cells |
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Publisher: | MDPI |
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Place of publication: | Basel |
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Document Type: | Article |
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Language: | English |
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Year of Completion: | 2019 |
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Date of first Publication: | 2019/12/05 |
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Publishing Institution: | Universitätsbibliothek Johann Christian Senckenberg |
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Release Date: | 2020/02/12 |
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Tag: | cell therapy; graft-versus host; hospital exemption; mesenchymal stromal cell; refractory aGvHD; steroid-resistant aGvHD; transplantation |
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Volume: | 8 |
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Issue: | 12, Art. 1577 |
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Page Number: | 13 |
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First Page: | 1 |
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Last Page: | 13 |
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Note: | This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited |
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HeBIS-PPN: | 460951327 |
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Institutes: | Medizin / Medizin |
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Dewey Decimal Classification: | 6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit |
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Sammlungen: | Universitätspublikationen |
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Licence (German): | Creative Commons - Namensnennung 4.0 |
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