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Completed
NCT04260698
Expanded Access of Omidubicel, for Allogeneic Transplantation in Patients With Hematological Malignancies
Conditions: Hematological Malignancies
Sex: All
Ages: 12 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 36
Sponsor: Gamida Cell ltd
Location: UCLA Los Angeles California
Summary
Omidubicel is an investigational therapy for patients with high-risk hematologic malignancies.
Eligibility Criteria
Inclusion Criteria:
* Patients must be at least 12 years of age
* Applicable disease criteria
* Patients must have one or two partially HLA-matched CBUs
* Back-up stem cell source
* Sufficient physiological reserves
* Females of childbearing potential agree to use appropriate method of contraception
* Signed written informed consent
Exclusion Criteria:
* Extensive bone marrow fibrosis
* Donor specific anti-HLA antibodies
* Pregnancy
* Medically unsuitable for transplant
Source: ClinicalTrials.gov (NCT04260698). StuddyBuddy aggregates publicly available trial information.