Description:
Omidubicel is an investigational therapy for patients with high-risk hematologic malignancies.
Clinical Trials /
Expanded Access of Omidubicel, for Allogeneic Transplantation in Patients With Hematological Malignancies
NCT04260698
Related Conditions:
- Hematopoietic and Lymphoid Malignancy
Recruiting Status:
Recruiting
Phase:
Phase 3
Trial Eligibility
Document
Title
- Brief Title: Expanded Access of Omidubicel, for Allogeneic Transplantation in Patients With Hematological Malignancies
- Official Title: An Open Label Expanded Access Study of Omidubicel, for Allogeneic Transplantation in Patients With Hematological Malignancies
Clinical Trial IDs
- ORG STUDY ID: GC P#07.01.020
- NCT ID: NCT04260698
Conditions
- Hematological Malignancies
Interventions
| Drug | Synonyms | Arms |
|---|---|---|
| omidubicel | NiCord | omidubicel |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|---|---|---|
| omidubicel | Experimental | Omidubicel is a cryopreserved stem/progenitor cell based product comprised of: Ex vivo expanded, umbilical cord blood-derived hematopoietic CD34+ progenitor cells (cultured fraction (CF)) the non-cultured cell fraction of the same Cord Blood Unit (CBU) (Non-cultured Fraction (NF)) consisting of mature myeloid and lymphoid cells. Both fractions, i.e. CF and NF, will be kept frozen until they are thawed and infused on the day of transplantation. |
|
Eligibility Criteria
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 12 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | To assess the time from transplant to neutrophil engraftment |
| Time Frame: | by day 42 post-transplant inclusive |
| Safety Issue: | |
| Description: |
Details
| Phase: | Phase 3 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Gamida Cell ltd |
Last Updated
February 23, 2021
