This study is in progress, not accepting new patients

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

a study on Hematologic Malignancy Neoplasms Hematologic Neoplasms

Summary

Eligibility
for people ages 12 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around
Principal Investigator
by Gary Schiller

Description

Summary

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

Official Title

An Open Label Expanded Access Study of Omidubicel, for Allogeneic Transplantation in Patients With Hematological Malignancies

Details

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.

Keywords

Hematological Malignancies, Neoplasms, Hematologic Neoplasms, omidubicel

Eligibility

You can join if…

Open to people ages 12 years and up

  • 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

You CAN'T join if...

  • Extensive bone marrow fibrosis
  • Donor specific anti-HLA antibodies
  • Pregnancy
  • Medically unsuitable for transplant

Locations

  • UCLA
    Los Angeles California 90095 United States
  • Stanford University Cancer Institute
    Palo Alto California 94063 United States

Lead Scientist at UCLA

  • Gary Schiller
    Professor-in-Residence, Medicine. Authored (or co-authored) 162 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gamida Cell ltd
ID
NCT04260698
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 36 people participating
Last Updated