Expanded Access of Omidubicel, for Allogeneic Transplantation in Patients With Hematological Malignancies
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|ClinicalTrials.gov Identifier: NCT04260698|
Recruitment Status : Not yet recruiting
First Posted : February 7, 2020
Last Update Posted : February 12, 2020
|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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Expanded Access Study of Omidubicel, for Allogeneic Transplantation in Patients With Hematological Malignancies|
|Estimated Study Start Date :||June 15, 2020|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2024|
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.
hematopoietic stem cell transplant
Other Name: NiCord
- To assess the time from transplant to neutrophil engraftment [ Time Frame: by day 42 post-transplant inclusive ]
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 Myersfirstname.lastname@example.org|
|Principal Investigator:||Mitchell Horwitz, MD||Duke University|