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dc.contributor.authorBader, P
dc.contributor.authorKuçi, Z
dc.contributor.authorBakhtiar, S
dc.contributor.authorBasu, O
dc.contributor.authorBug, G
dc.contributor.authorDennis, Michael
dc.contributor.authorGreil, J
dc.contributor.authorBarta, A
dc.contributor.authorKállay, K
dc.contributor.authorLang, P
dc.contributor.authorLucchini, G
dc.contributor.authorPol, R
dc.contributor.authorSchulz, A
dc.contributor.authorSykora, K
dc.contributor.authorvon Luettichau, I
dc.contributor.authorHerter-Sprie, G
dc.contributor.authorUddin, M
dc.contributor.authorJenkin, P
dc.contributor.authorAlsultan, A
dc.contributor.authorBuechner, J
dc.contributor.authorStein, J
dc.contributor.authorKelemen, A
dc.contributor.authorJarisch, A
dc.contributor.authorSoerensen, J
dc.contributor.authorSalzmann-Manrique, E
dc.contributor.authorHutter, M
dc.contributor.authorSchäfer, R
dc.contributor.authorSeifried, E
dc.contributor.authorKlingebiel, T
dc.contributor.authorBonig, H
dc.contributor.authorKuçi, S
dc.date.accessioned2018-03-17T21:26:36Z
dc.date.available2018-03-17T21:26:36Z
dc.date.issued2018-01-29
dc.identifier.citationEffective treatment of steroid and therapy-refractory acute graft-versus-host disease with a novel mesenchymal stromal cell product (MSC-FFM). 2018, Bone Marrow Transplanten
dc.identifier.issn1476-5365
dc.identifier.pmid29379171
dc.identifier.doi10.1038/s41409-018-0102-z
dc.identifier.urihttp://hdl.handle.net/10541/620850
dc.description.abstractThe 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.
dc.language.isoenen
dc.rightsArchived with thanks to Bone marrow transplantationen
dc.titleEffective treatment of steroid and therapy-refractory acute graft-versus-host disease with a novel mesenchymal stromal cell product (MSC-FFM).en
dc.typeArticleen
dc.contributor.departmentDepartment for Children and Adolescents, Division for Stem Cell Transplantation and Immunology, University Hospital Frankfurt, Frankfurt am Main, Germanyen
dc.identifier.journalBone Marrow Transplantationen
refterms.dateFOA2018-12-17T15:18:20Z
html.description.abstractThe 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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