{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T12:36:11Z","timestamp":1790944571445,"version":"4.1.0"},"reference-count":36,"publisher":"MDPI AG","issue":"12","license":[{"start":{"date-parts":[[2019,12,5]],"date-time":"2019-12-05T00:00:00Z","timestamp":1575504000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cells"],"abstract":"<jats:p>(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 \u2265\u00b0III, one-third only steroid-refractory and two-thirds therapy resistant (refractory to steroids plus \u22652 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.<\/jats:p>","DOI":"10.3390\/cells8121577","type":"journal-article","created":{"date-parts":[[2019,12,5]],"date-time":"2019-12-05T11:16:23Z","timestamp":1575544583000},"page":"1577","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":60,"title":["Children and Adults with Refractory Acute Graft-versus-Host Disease Respond to Treatment with the Mesenchymal Stromal Cell Preparation \u201cMSC-FFM\u201d\u2014Outcome Report of 92 Patients"],"prefix":"10.3390","volume":"8","author":[{"given":"Halvard","family":"Bonig","sequence":"first","affiliation":[{"name":"Goethe University Medical Center, Institute of Transfusion Medicine and Immunohematology, and German Red Cross Blood Center Frankfurt, Frankfurt am Main, Frankfurt 60528, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zyrafete","family":"Ku\u00e7i","sequence":"additional","affiliation":[{"name":"Division for Stem Cell Transplantation and Immunology, Department for Children and Adolescents, University Hospital Frankfurt, Frankfurt am Main, Frankfurt 60590, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Selim","family":"Ku\u00e7i","sequence":"additional","affiliation":[{"name":"Division for Stem Cell Transplantation and Immunology, Department for Children and Adolescents, University Hospital Frankfurt, Frankfurt am Main, Frankfurt 60590, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shahrzad","family":"Bakhtiar","sequence":"additional","affiliation":[{"name":"Division for Stem Cell Transplantation and Immunology, Department for Children and Adolescents, University Hospital Frankfurt, Frankfurt am Main, Frankfurt 60590, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Oliver","family":"Basu","sequence":"additional","affiliation":[{"name":"University Children\u2019s Hospital Essen, Essen 45122, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gesine","family":"Bug","sequence":"additional","affiliation":[{"name":"Department of Medicine 2, Hematology and Oncology, University Hospital, Goethe University Frankfurt, Frankfurt am Main 60590, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mike","family":"Dennis","sequence":"additional","affiliation":[{"name":"Christie Hospital, Department of Haematology, Manchester M20 4BX, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Johann","family":"Greil","sequence":"additional","affiliation":[{"name":"University Children\u2019s Hospital Heidelberg, Heidelberg 69120, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aniko","family":"Barta","sequence":"additional","affiliation":[{"name":"Central Hospital of Southern Pest, National Institute of Hematology and Infectious Diseases, Department for Haematology and SCT, Budapest H1097, Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4328-9612","authenticated-orcid":false,"given":"Kriszti\u00e1n M.","family":"K\u00e1llay","sequence":"additional","affiliation":[{"name":"Central Hospital of Southern Pest, National Institute of Hematology and Infectious Diseases, Pediatric Hematology and Stem Cell Transplantation Department, Budapest H1097, Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Lang","sequence":"additional","affiliation":[{"name":"University Children\u2019s Hospital T\u00fcbingen, T\u00fcbingen 72076, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giovanna","family":"Lucchini","sequence":"additional","affiliation":[{"name":"Great Ormond Street Hospital, Department of Hematology\/Oncology, London WC1N 3JH, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raj","family":"Pol","sequence":"additional","affiliation":[{"name":"Department of Haematology, University of Sheffield, Sheffield S10 2TN, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7798-7996","authenticated-orcid":false,"given":"Ansgar","family":"Schulz","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, University Medical Center Ulm, Ulm 89070, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karl-Walter","family":"Sykora","sequence":"additional","affiliation":[{"name":"Children\u2019s Hospital, Medizinische Hochschule Hannover, Hannover 30625, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Irene","family":"Teichert von Luettichau","sequence":"additional","affiliation":[{"name":"Division of Pediatric Hematology\/Oncology, Department of Pediatrics, Kinderklinik M\u00fcnchen Schwabing, Klinikum Rechts der Isar, Technische Universit\u00e4t M\u00fcnchen, M\u00fcnchen 80804, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Grit","family":"Herter-Sprie","sequence":"additional","affiliation":[{"name":"Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, Center for Molecular Medicine Cologne, University of Cologne, Cologne 50937, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohammad","family":"Ashab Uddin","sequence":"additional","affiliation":[{"name":"Department for Stem Cells &amp; Immunotherapies, NHSBT, Birmingham B15 2SG, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Phil","family":"Jenkin","sequence":"additional","affiliation":[{"name":"Department for Stem Cells &amp; Immunotherapies, NHSBT, Birmingham B15 2SG, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5577-3228","authenticated-orcid":false,"given":"Abdulrahman","family":"Alsultan","sequence":"additional","affiliation":[{"name":"Department of Pediatric Hematology\/Oncology, King Abdullah Specialist Children\u2019s Hospital, Riyadh 14611, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jochen","family":"Buechner","sequence":"additional","affiliation":[{"name":"Oslo University Hospital, Department of Pediatric Hematology and Oncology, Oslo 0424, Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jerry","family":"Stein","sequence":"additional","affiliation":[{"name":"Schneider Children\u2019s Medical Center of Israel, Department for Hemato-Oncology, Petach Tikva 4920235, Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Agnes","family":"Kelemen","sequence":"additional","affiliation":[{"name":"B-A-Z County Hospital, Pediatric Haematology and Stem Cell Transplantation Unit, Miskolc 3526, Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Jarisch","sequence":"additional","affiliation":[{"name":"Division for Stem Cell Transplantation and Immunology, Department for Children and Adolescents, University Hospital Frankfurt, Frankfurt am Main, Frankfurt 60590, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jan","family":"Soerensen","sequence":"additional","affiliation":[{"name":"Division for Stem Cell Transplantation and Immunology, Department for Children and Adolescents, University Hospital Frankfurt, Frankfurt am Main, Frankfurt 60590, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emilia","family":"Salzmann-Manrique","sequence":"additional","affiliation":[{"name":"Division for Stem Cell Transplantation and Immunology, Department for Children and Adolescents, University Hospital Frankfurt, Frankfurt am Main, Frankfurt 60590, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Hutter","sequence":"additional","affiliation":[{"name":"Division for Stem Cell Transplantation and Immunology, Department for Children and Adolescents, University Hospital Frankfurt, Frankfurt am Main, Frankfurt 60590, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard","family":"Sch\u00e4fer","sequence":"additional","affiliation":[{"name":"Goethe University Medical Center, Institute of Transfusion Medicine and Immunohematology, and German Red Cross Blood Center Frankfurt, Frankfurt am Main, Frankfurt 60528, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erhard","family":"Seifried","sequence":"additional","affiliation":[{"name":"Goethe University Medical Center, Institute of Transfusion Medicine and Immunohematology, and German Red Cross Blood Center Frankfurt, Frankfurt am Main, Frankfurt 60528, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shankara","family":"Paneesha","sequence":"additional","affiliation":[{"name":"Department of Haematology &amp; Stem Cell Transplantation, Birmingham Heartlands Hospital, Birmingham B9 5SS, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Igor","family":"Novitzky-Basso","sequence":"additional","affiliation":[{"name":"Queen Elizabeth University Hospital, Glasgow, Glasgow G51 4TF, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aharon","family":"Gefen","sequence":"additional","affiliation":[{"name":"Rambam Medical Center, Ruth Rappaport Children\u2019s Hospital, Pediatric Hematology Oncology Division, The Reiner-Shudi Pediatric Bone Marrow Transplantation Unit, Haifa 3109601, Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Neta","family":"Nevo","sequence":"additional","affiliation":[{"name":"Rambam Medical Center, Ruth Rappaport Children\u2019s Hospital, Pediatric Hematology Oncology Division, The Reiner-Shudi Pediatric Bone Marrow Transplantation Unit, Haifa 3109601, Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gernot","family":"Beutel","sequence":"additional","affiliation":[{"name":"Hannover Medical School (MHH), Hannover, Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Hannover 30625, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul-Gerhardt","family":"Schlegel","sequence":"additional","affiliation":[{"name":"University Children\u2019s Hospital W\u00fcrzburg, W\u00fcrzburg 97080, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Klingebiel","sequence":"additional","affiliation":[{"name":"Division for Stem Cell Transplantation and Immunology, Department for Children and Adolescents, University Hospital Frankfurt, Frankfurt am Main, Frankfurt 60590, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4554-0265","authenticated-orcid":false,"given":"Peter","family":"Bader","sequence":"additional","affiliation":[{"name":"Division for Stem Cell Transplantation and Immunology, Department for Children and Adolescents, University Hospital Frankfurt, Frankfurt am Main, Frankfurt 60590, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2019,12,5]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"1150","DOI":"10.1016\/j.bbmt.2012.04.005","article-title":"First- and second-line systemic treatment 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