Bonig, Halvard, Kuci, Zyrafete, Kuci, Selim ORCID: 0000-0002-0105-1083, Bakhtiar, Shahrzad, Basu, Oliver, Bug, Gesine, Dennis, Mike, Greil, Johann, Barta, Aniko, Kallay, Krisztian M., Lang, Peter, Lucchini, Giovanna, Pol, Raj, Schulz, Ansgar ORCID: 0000-0002-7798-7996, Sykora, Karl-Walter, von Luettichau, Irene Teichert, Herter-Sprie, Grit, Uddin, Mohammad Ashab, Jenkin, Phil, Alsultan, Abdulrahman ORCID: 0000-0001-5577-3228, Buechner, Jochen, Stein, Jerry, Kelemen, Agnes, Jarisch, Andrea, Soerensen, Jan, Salzmann-Manrique, Emilia, Hutter, Martin, Schaefer, Richard, Seifried, Erhard, Paneesha, Shankara, Novitzky-Basso, Igor ORCID: 0000-0003-3748-3117, Gefen, Aharon, Nevo, Neta, Beutel, Gernot, Schlegel, Paul-Gerhardt, Klingebiel, Thomas and Bader, Peter ORCID: 0000-0003-4554-0265 (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). BASEL: MDPI. ISSN 2073-4409

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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 >=degrees 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: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Bonig, HalvardUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kuci, ZyrafeteUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kuci, SelimUNSPECIFIEDorcid.org/0000-0002-0105-1083UNSPECIFIED
Bakhtiar, ShahrzadUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Basu, OliverUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bug, GesineUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dennis, MikeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Greil, JohannUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Barta, AnikoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kallay, Krisztian M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lang, PeterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lucchini, GiovannaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pol, RajUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schulz, AnsgarUNSPECIFIEDorcid.org/0000-0002-7798-7996UNSPECIFIED
Sykora, Karl-WalterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
von Luettichau, Irene TeichertUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Herter-Sprie, GritUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Uddin, Mohammad AshabUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Jenkin, PhilUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Alsultan, AbdulrahmanUNSPECIFIEDorcid.org/0000-0001-5577-3228UNSPECIFIED
Buechner, JochenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Stein, JerryUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kelemen, AgnesUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Jarisch, AndreaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Soerensen, JanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Salzmann-Manrique, EmiliaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hutter, MartinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schaefer, RichardUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Seifried, ErhardUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Paneesha, ShankaraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Novitzky-Basso, IgorUNSPECIFIEDorcid.org/0000-0003-3748-3117UNSPECIFIED
Gefen, AharonUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Nevo, NetaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Beutel, GernotUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schlegel, Paul-GerhardtUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Klingebiel, ThomasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bader, PeterUNSPECIFIEDorcid.org/0000-0003-4554-0265UNSPECIFIED
URN: urn:nbn:de:hbz:38-125438
DOI: 10.3390/cells8121577
Journal or Publication Title: Cells
Volume: 8
Number: 12
Date: 2019
Publisher: MDPI
Place of Publication: BASEL
ISSN: 2073-4409
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
RESISTANT ACUTE GVHD; STEROID-RESISTANT; STEM-CELLS; PLATELET LYSATE; MARROW; THERAPY; INFUSIONMultiple languages
Cell BiologyMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/12543

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