Expanded Access of Omidubicel, for Allogeneic Transplantation in Patients With Hematological Malignancies

Status: complete

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

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

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.

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