Trial Search Results

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

This is an open-label, non-randomized, interventional, single group assignment study of omidubicel in patients with hematologicalmalignancies for whom allogeneic stem cell transplant (SCT) is currently a recommended and potentially lifesaving treatment, allwith required disease features rendering them eligible for allogeneic transplantation.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Gamida Cell ltd

Stanford Investigator(s):

Intervention(s):

  • Biological: omidubicel

Phase:

Phase 3

Eligibility


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

Ages Eligible for Study

12 Years - N/A

Genders Eligible for Study

All