{"entity":{"id":"dorocubicel","kind":"drug","name":"Dorocubicel (UM171-expanded cord blood)","aka":["UM171 cell therapy","ECT-001"],"tldr":"Zemcelpro is a laboratory-expanded umbilical cord blood transplant for adults with blood cancers who need a donor stem cell transplant but have no suitable matched donor; expanding the cells lets a single small cord blood unit be enough.","summary":"Dorocubicel was authorised by the European Commission in August 2025 as an advanced therapy medicinal product for adults with haematological malignancies requiring allogeneic haematopoietic stem cell transplantation after myeloablative conditioning for whom no other suitable donor cells are available. It consists of the CD34-positive fraction of a single cord blood unit expanded with UM171, a pyrimidoindole agonist of stem cell self-renewal discovered at Universite de Montreal, together with the unexpanded CD34-negative cells. Phase 2 studies showed faster neutrophil engraftment than historical unmanipulated cord blood and low rates of severe chronic graft-versus-host disease, addressing the slow engraftment that limited cord blood transplants in adults. It is not approved in the US. Risks are those of allogeneic transplantation: infection, graft failure and graft-versus-host disease. Developed by ExCellThera.","status":"approved","asOf":"2026-09-10","wikipedia":"https://en.wikipedia.org/wiki/Cord_blood","links":[{"label":"EPAR (EMA)","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/zemcelpro"}],"tags":["ema-list"],"related":[],"cancers":["aml","all-leukemia","mds"],"sections":[],"technologies":["allogeneic-hsct","allogeneic-cell-therapy"],"targets":[],"drugs":[],"companies":["excellthera"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Zemcelpro","modality":"Allogeneic expanded cord blood cell therapy (ATMP)","mechanism":"CD34-positive cord blood cells expanded ex vivo for seven days with the small molecule UM171, which preserves haematopoietic stem cell self-renewal, co-infused with the non-expanded CD34-negative fraction to reconstitute haematopoiesis after myeloablative conditioning.","approvals":[{"region":"EU","year":2025,"indication":"Adults with haematological malignancies requiring allogeneic HSCT after myeloablative conditioning with no other suitable donor cells"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/dorocubicel/","neighbours":{"cancer":[{"id":"all-leukemia","kind":"cancer","name":"Acute lymphoblastic leukaemia","route":"/cancers/all-leukemia/"},{"id":"aml","kind":"cancer","name":"Acute myeloid leukaemia","route":"/cancers/aml/"},{"id":"mds","kind":"cancer","name":"Myelodysplastic syndromes / neoplasms (MDS)","route":"/cancers/mds/"}],"technology":[{"id":"allogeneic-cell-therapy","kind":"technology","name":"Allogeneic (off-the-shelf) cell therapy","route":"/technologies/allogeneic-cell-therapy/"},{"id":"allogeneic-hsct","kind":"technology","name":"Allogeneic stem cell transplantation","route":"/technologies/allogeneic-hsct/"}],"company":[{"id":"excellthera","kind":"company","name":"ExCellThera","route":"/companies/excellthera/"}]}}