Expanded Access of Omidubicel, for Allogeneic Transplantation in Patients With Hematological Malignancies
An Open Label Expanded Access Study of Omidubicel, for Allogeneic Transplantation in Patients With Hematological Malignancies
1 other identifier
interventional
36
1 country
6
Brief Summary
Omidubicel is an investigational therapy for patients with high-risk hematologic malignancies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2020
Longer than P75 for phase_3
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2020
CompletedFirst Posted
Study publicly available on registry
February 7, 2020
CompletedStudy Start
First participant enrolled
July 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 8, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 8, 2025
CompletedJuly 2, 2025
June 1, 2025
4.8 years
February 5, 2020
June 29, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
To assess the time from transplant to neutrophil engraftment
by day 42 post-transplant inclusive
Study Arms (1)
omidubicel
EXPERIMENTALOmidubicel is a cryopreserved stem/progenitor cell based product comprised of: 1. Ex vivo expanded, umbilical cord blood-derived hematopoietic CD34+ progenitor cells (cultured fraction (CF)) 2. the non-cultured cell fraction of the same Cord Blood Unit (CBU) (Non-cultured Fraction (NF)) consisting of mature myeloid and lymphoid cells. Both fractions, i.e. CF and NF, will be kept frozen until they are thawed and infused on the day of transplantation.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Extensive bone marrow fibrosis
- Donor specific anti-HLA antibodies
- Pregnancy
- Medically unsuitable for transplant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gamida Cell ltdlead
Study Sites (6)
UCLA
Los Angeles, California, 90095, United States
Stanford University Cancer Institute
Palo Alto, California, 94063, United States
Loyola University, Cardinal Bernardin Cancer Center
Maywood, Illinois, 60153, United States
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, 55455, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mitchell Horwitz, MD
Duke University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2020
First Posted
February 7, 2020
Study Start
July 8, 2020
Primary Completion
May 8, 2025
Study Completion
May 8, 2025
Last Updated
July 2, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share