Expanded Access of Omidubicel, for Allogeneic Transplantation in Patients With Hematological Malignancies
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04260698 |
Recruitment Status :
Recruiting
First Posted : February 7, 2020
Last Update Posted : June 10, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hematological Malignancies | Biological: omidubicel | Phase 3 |
Successful blood and marrow transplantation (BMT) requires the infusion of a sufficient number of hematopoietic stem/progenitor cells (HSPCs), capable of both homing to the bone marrow and regenerating a full array of hematopoietic cell lineages with early and late repopulating ability in a timely fashion.
Omidubicel is a stem/progenitor cell-based product composed of ex vivo expanded allogeneic cells from one entire unit of umbilical cord blood. Omidubicel utilizes the small molecule nicotinamide (NAM), as an epigenetic approach to inhibit differentiation and to increase the migration, bone marrow (BM) homing and engraftment efficiency of hematopoietic progenitor cells (HPC) expanded in ex vivo cultures.
The overall study objectives are to provide access to omidubicel for transplantation in patients with hematological malignancies and to collect additional safety and efficacy data.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open Label Expanded Access Study of Omidubicel, for Allogeneic Transplantation in Patients With Hematological Malignancies |
Actual Study Start Date : | July 8, 2020 |
Estimated Primary Completion Date : | December 31, 2023 |
Estimated Study Completion Date : | December 31, 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: omidubicel
Omidubicel is a cryopreserved stem/progenitor cell based product comprised of:
Both fractions, i.e. CF and NF, will be kept frozen until they are thawed and infused on the day of transplantation. |
Biological: omidubicel
hematopoietic stem cell transplant
Other Name: NiCord |
- To assess the time from transplant to neutrophil engraftment [ Time Frame: by day 42 post-transplant inclusive ]

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Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04260698
Contact: Kelly Myers | +97226595631 | kelly@gamida-cell.com |
United States, California | |
UCLA | Recruiting |
Los Angeles, California, United States, 90095 | |
Contact: Gary Schiller, MD GSchiller@mednet.ucla.edu | |
Principal Investigator: Gary Schiller, MD | |
Stanford University Cancer Institute | Recruiting |
Palo Alto, California, United States, 94063 | |
Contact: Andrew Rezvani,, MD 650-498-6000 | |
United States, Illinois | |
Loyola University, Cardinal Bernardin Cancer Center | Recruiting |
Maywood, Illinois, United States, 60153 | |
Contact: Stephanie Tsai, MD 708-327-3216 | |
Principal Investigator: Stephanie Tsai, MD | |
United States, Minnesota | |
University of Minnesota Masonic Cancer Center | Recruiting |
Minneapolis, Minnesota, United States, 55455 | |
Contact: John Wagner, MD 612-625-3918 | |
Principal Investigator: John Wagner, MD | |
United States, North Carolina | |
Duke University Medical Center | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: Mitchell Horwitz, MD 919-668-1045 mitchell.horwitz@duke.edu | |
Principal Investigator: Mitchell Horwitz, MD | |
United States, Oregon | |
Oregon Health & Science University | Recruiting |
Portland, Oregon, United States, 97239 | |
Contact: Richard Maziarz, MD 503-494-4606 maziarzr@ohsu.edu | |
Principal Investigator: Richard Maziarz, MD |
Principal Investigator: | Mitchell Horwitz, MD | Duke University |
Responsible Party: | Gamida Cell ltd |
ClinicalTrials.gov Identifier: | NCT04260698 |
Other Study ID Numbers: |
GC P#07.01.020 |
First Posted: | February 7, 2020 Key Record Dates |
Last Update Posted: | June 10, 2022 |
Last Verified: | June 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Neoplasms Hematologic Neoplasms Neoplasms by Site Hematologic Diseases |