Expanded Access of Omidubicel for Allogeneic Transplantation in Patients With Hematological Malignancies
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- STATUS
- Recruiting
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- participants needed
- 60
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- sponsor
- Gamida Cell ltd
Summary
Omidubicel is an investigational therapy for patients with high-risk hematologic malignancies.
Description
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.
Details
| Condition | Hematologic Malignancy, Blood disorder |
|---|---|
| Age | 12years - 100years |
| Treatment | omidubicel |
| Clinical Study Identifier | NCT04260698 |
| Sponsor | Gamida Cell ltd |
| Last Modified on | 19 February 2024 |
How to participate?
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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