Effective treatment of steroid and therapy-refractory acute graft-versus-host disease with a novel mesenchymal stromal cell product (MSC-FFM)
The inability to generate mesenchymal stromal cells (MSCs) of consistent potency likely is responsible for inconsistent clinical outcomes of patients with aGvHD receiving MSC products. We developed a novel MSC manufacturing protocol characterized by high in vitro potency and near-identity of individ...
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| Main Authors: | , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
29 January 2018
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| In: |
Bone marrow transplantation
Year: 2018, Volume: 53, Issue: 7, Pages: 852-862 |
| ISSN: | 1476-5365 |
| DOI: | 10.1038/s41409-018-0102-z |
| Online Access: | Verlag, Volltext: https://doi.org/10.1038/s41409-018-0102-z Verlag: https://www.nature.com/articles/s41409-018-0102-z 
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| Author Notes: | Peter Bader, Zyrafete Kuçi, Shahrzad Bakhtiar, Oliver Basu, Gesine Bug, Michael Dennis, Johann Greil, Aniko Barta, Krisztián M. Kállay, Peter Lang, Giovanna Lucchini, Raj Pol, Ansgar Schulz, Karl-Walter Sykora, Irene von Luettichau, Grit Herter-Sprie, Mohammad Ashab Uddin, Phil Jenkin, Abdulrahman Alsultan, Jochen Buechner, Jerry Stein, Agnes Kelemen, Andrea Jarisch, Jan Soerensen, Emilia Salzmann-Manrique, Martin Hutter, Richard Schäfer, Erhard Seifried, Thomas Klingebiel, Halvard Bonig, Selim Kuçi |
| Summary: | The inability to generate mesenchymal stromal cells (MSCs) of consistent potency likely is responsible for inconsistent clinical outcomes of patients with aGvHD receiving MSC products. We developed a novel MSC manufacturing protocol characterized by high in vitro potency and near-identity of individual doses, referred to as “MSC-Frankfurt am Main (MSC-FFM)”. Herein, we report outcomes of the 69 patients who have received MSC-FFM. These were 51 children and 18 adults with refractory aGvHD grade II (4%), III (36%) or IV (59%). Patients were refractory either to frontline therapy (steroids) (29%) or to steroids and 1-5 additional lines of immunosuppressants (71%) were given infusions in four weekly intervals. The day 28 overall response rate was 83%; at the last follow-up, 61% and 25% of patients were in complete or partial remission. The median follow-up was 8.1 months. Six-month estimate for cumulative incidence of non-relapse mortality was 27% (range, 16-38); leukemia relapse mortality was 2% (range, 0-5). This was associated with a superior six-month overall survival (OS) probability rate of 71% (range, 61-83), compared to the outcome of patients not treated with MSC-FFM. This novel product was effective in children and adults, suggesting that MSC-FFM represents a promising therapy for steroid refractory aGvHD. |
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| Item Description: | Gesehen am 02.03.2020 |
| Physical Description: | Online Resource |
| ISSN: | 1476-5365 |
| DOI: | 10.1038/s41409-018-0102-z |