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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    60
  • sponsor
    Gamida Cell ltd
Updated on 2 March 2021
cancer
allogeneic transplantation

Summary

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

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.

Details
Condition Hematologic Malignancy, Blood disorder, Blood Cancer, Hematologic Cancer, Hematological Disorders, Hematologic Neoplasms, hematological malignancy, hematologic malignancies, hematological tumor, haematological malignancy, hematological malignancies
Treatment omidubicel
Clinical Study IdentifierNCT04260698
SponsorGamida Cell ltd
Last Modified on2 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 12 yrs?
Gender: Male or Female
Do you have any of these conditions: Hematological Disorders or Blood Cancer or Hematologic Neoplasms or Blood disorder or Hematologic Cancer or Hematologic Malignancy?
Do you have any of these conditions: Hematologic Malignancy or Blood Cancer or Hematological Disorders or Blood disorder or hematological malignancies or hematological tumor or Hematologi...?
Do you have any of these conditions: Hematological Disorders or hematologic malignancies or Blood disorder or hematological tumor or Hematologic Neoplasms or Hematologic Malignancy or Blo...?
Do you have any of these conditions: Blood Cancer or hematologic malignancies or haematological malignancy or Hematologic Cancer or hematological tumor or Blood disorder or Hematologic Ne...?
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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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