NCT04260698

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Gamida Cell ltd · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

Omidubicel is an investigational therapy for patients with high-risk hematologic malignancies.

Detailed 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.

Conditions

• Hematological Malignancies

Interventions

Type	Name	Description
BIOLOGICAL	omidubicel	hematopoietic stem cell transplant

Timeline

• Start date: 2020-07-08
• Primary completion: 2025-05-08
• Completion: 2025-05-08
• First posted: 2020-02-07
• Last updated: 2025-07-02

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study