{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T12:37:25Z","timestamp":1793277445213,"version":"4.5.0"},"reference-count":36,"publisher":"SAGE Publications","issue":"5-6","license":[{"start":{"date-parts":[[2024,3,1]],"date-time":"2024-03-01T00:00:00Z","timestamp":1709251200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Stem Cells and Development"],"published-print":{"date-parts":[[2024,3]]},"abstract":"<jats:p>\n                    Solid abdominal organ transplantation is fraught with variable rates of rejection and graft versus host disease (GVHD). We sought to determine the safety and efficacy of an advanced extracellular vesicle (EV) investigational product (IP) derived from mesenchymal stem cells (MSC) in the transplant patient population. Seven separate emergency investigational new drug (eNIDs) were filed with the Food and Drug Administration (FDA) for the emergency treatment of rejection of an isolated intestinal graft (\n                    <jats:italic toggle=\"yes\">n<\/jats:italic>\n                    \u2009=\u20092), liver allograft graft (\n                    <jats:italic toggle=\"yes\">n<\/jats:italic>\n                    \u2009=\u20092), modified multivisceral graft (\n                    <jats:italic toggle=\"yes\">n<\/jats:italic>\n                    \u2009=\u20093), and GVHD in isolated intestinal transplant patients (\n                    <jats:italic toggle=\"yes\">n<\/jats:italic>\n                    \u2009=\u20092). Fifteen milliliters of IP was administered intravenously on Day 0, 2, 4, and this treatment cycle was repeated up to four times in each patient depending on the treatment protocol allowed by the FDA. Safety (adverse event reporting) and efficacy (clinical status, serologies, and histopathology) were evaluated. There were no adverse events related to IP. All patients had improvement in clinical symptoms within 24\u2009h, improved serologic laboratory evaluation, improved pulmonary symptoms and dermatologic manifestations of GVHD, and complete histologic resolution of graft inflammation\/rejection within 7 days of IP administration. Systemic use of a MSC-derived EV IP was successful in achieving histological clearance of intestinal, liver, and multivisceral graft inflammation, and skin and pulmonary manifestations of GVHD.\n                  <\/jats:p>","DOI":"10.1089\/scd.2023.0273","type":"journal-article","created":{"date-parts":[[2024,2,1]],"date-time":"2024-02-01T09:28:46Z","timestamp":1706779726000},"page":"107-116","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":13,"title":["Mesenchymal Stem Cell Extracellular Vesicles as a New Treatment Paradigm in Solid Abdominal Organ Transplantation: A Case Series"],"prefix":"10.1177","volume":"33","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5713-5374","authenticated-orcid":false,"given":"Amy L.","family":"Lightner","sequence":"first","affiliation":[{"name":"Department of Colorectal Surgery, Center for Gut Rehabilitation and Transplantation, Digestive Disease and Surgery Institute, Cleveland Clinic, Ohio, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masato","family":"Fujiki","sequence":"additional","affiliation":[{"name":"Department of Abdominal Transplantation, Center for Gut Rehabilitation and Transplantation, Digestive Disease and Surgery Institute, Cleveland Clinic, Ohio, USA."},{"name":"Department of General Surgery, Center for Gut Rehabilitation and Transplantation, Digestive Disease and Surgery Institute, Cleveland Clinic, Ohio, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohamed","family":"Elshawy","sequence":"additional","affiliation":[{"name":"Department of Abdominal Transplantation, Center for Gut Rehabilitation and Transplantation, Digestive Disease and Surgery Institute, Cleveland Clinic, Ohio, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Neda","family":"Dadgar","sequence":"additional","affiliation":[{"name":"Department of Colorectal Surgery, Center for Gut Rehabilitation and Transplantation, Digestive Disease and Surgery Institute, Cleveland Clinic, Ohio, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anita","family":"Barnoski","sequence":"additional","affiliation":[{"name":"Department of Abdominal Transplantation, Center for Gut Rehabilitation and Transplantation, Digestive Disease and Surgery Institute, Cleveland Clinic, Ohio, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohammed","family":"Osman","sequence":"additional","affiliation":[{"name":"Department of Abdominal Transplantation, Center for Gut Rehabilitation and Transplantation, Digestive Disease and Surgery Institute, Cleveland Clinic, Ohio, USA."},{"name":"Department of General Surgery, Center for Gut Rehabilitation and Transplantation, Digestive Disease and Surgery Institute, Cleveland Clinic, Ohio, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Clifton G.","family":"Fulmer","sequence":"additional","affiliation":[{"name":"Department of Pathology, Robert J. Tomsich Pathology and Laboratory Medicine Institute, Cleveland Clinic, Ohio, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anil","family":"Vaidya","sequence":"additional","affiliation":[{"name":"Department of Abdominal Transplantation, Center for Gut Rehabilitation and Transplantation, Digestive Disease and Surgery Institute, Cleveland Clinic, Ohio, USA."},{"name":"Department of General Surgery, Center for Gut Rehabilitation and Transplantation, Digestive Disease and Surgery Institute, Cleveland Clinic, Ohio, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2024,3,4]]},"reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(08)60690-X"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1002\/art.27548"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.stem.2009.05.003"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jneuroim.2010.07.013"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1007\/s00384-003-0490-3"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.3727\/096368912X656045"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2017.04.001"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1007\/s10350-005-0052-6"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1007\/DCR.0b013e3181973487"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2015.06.014"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.5966\/sctm.2014-0199"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.1007\/s00384-012-1581-9"},{"key":"e_1_3_3_14_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(16)31203-X"},{"key":"e_1_3_3_15_2","doi-asserted-by":"publisher","DOI":"10.1136\/gut.2010.214841"},{"key":"e_1_3_3_16_2","doi-asserted-by":"publisher","DOI":"10.1002\/stem.1357"},{"key":"e_1_3_3_17_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.cellimm.2015.01.002"},{"key":"e_1_3_3_18_2","doi-asserted-by":"publisher","DOI":"10.1089\/scd.2013.0554"},{"key":"e_1_3_3_19_2","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2004-04-1559"},{"key":"e_1_3_3_20_2","doi-asserted-by":"publisher","DOI":"10.1182\/blood.V99.10.3838"},{"key":"e_1_3_3_21_2","doi-asserted-by":"publisher","DOI":"10.1007\/s11373-004-8183-7"},{"key":"e_1_3_3_22_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0301-472X(01)00769-X"},{"key":"e_1_3_3_23_2","doi-asserted-by":"crossref","first-page":"e0136991","DOI":"10.1371\/journal.pone.0136991","article-title":"Efficacy of mesenchymal stem cell therapy for steroid-refractory acute graft-versus-host disease following allogeneic hematopoietic stem cell transplantation: a systematic review and meta-analysis","volume":"10","author":"Chen X","year":"2015","unstructured":"Chen X, , Wang C, , Yin J, , Xu J, , Wei J, and Zhang Y. 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