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A Multi-Center, Multi-National, Historical Cohort Controlled Study to Evaluate Efficacy and Safety of Transplantation of StemEx, Umbilical Cord Blood (UCB) Stem and Progenitor Cells Expanded Ex Vivo, in Subjects with Hematologic Malignancies following Myeloablative Therapy

Trial Profile

A Multi-Center, Multi-National, Historical Cohort Controlled Study to Evaluate Efficacy and Safety of Transplantation of StemEx, Umbilical Cord Blood (UCB) Stem and Progenitor Cells Expanded Ex Vivo, in Subjects with Hematologic Malignancies following Myeloablative Therapy

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 13 Feb 2019

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At a glance

  • Drugs Carlecortemcel-L (Primary)
  • Indications Acute myeloid leukaemia; Chronic myeloid leukaemia; Hodgkin's disease; Myelodysplastic syndromes; Non-Hodgkin's lymphoma; Precursor cell lymphoblastic leukaemia-lymphoma
  • Focus Registrational; Therapeutic Use
  • Acronyms ExCELL
  • Sponsors Teva Pharmaceutical Industries - Gamida-Cell (JV)
  • Most Recent Events

    • 09 Jul 2015 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 09 Jul 2015 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 01 Jul 2013 Based on interim results from this trial, the FDA has recommended that an additional phase III trial be conducted for registration, according to a Gamida Cell media release.
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