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Stem Cell Transplant
Omidubicel for Blood Cancers
Phase 3
Waitlist Available
Led By Mitchell Horwitz, MD
Research Sponsored by Gamida Cell ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must be at least 12 years of age
Patients must have one or two partially HLA-matched CBUs
Timeline
Screening 3 weeks
Treatment Varies
Follow Up by day 42 post-transplant inclusive
Awards & highlights
Study Summary
This trial is testing a new therapy for people with blood cancers who are at high risk.
Who is the study for?
This trial is for patients aged 12 or older with high-risk blood cancers who have at least one partially HLA-matched cord blood unit available. They must be physically able to undergo a transplant and not pregnant. A backup stem cell source is required, and women of childbearing age must agree to use contraception.Check my eligibility
What is being tested?
The trial is testing omidubicel, an experimental therapy designed to improve outcomes in allogeneic transplantation for individuals with serious hematologic malignancies (blood cancers).See study design
What are the potential side effects?
While specific side effects are not listed here, typical risks may include reactions related to bone marrow transplant like infection risk increase, graft-versus-host disease, bleeding complications, and potential organ damage.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am at least 12 years old.
Select...
I have 1 or 2 partially matched cord blood units for transplant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ by day 42 post-transplant inclusive
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~by day 42 post-transplant inclusive
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To assess the time from transplant to neutrophil engraftment
Trial Design
1Treatment groups
Experimental Treatment
Group I: omidubicelExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Gamida Cell ltdLead Sponsor
8 Previous Clinical Trials
254 Total Patients Enrolled
Mitchell Horwitz, MDPrincipal InvestigatorDuke University
13 Previous Clinical Trials
498 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am at least 12 years old.I have a backup source for stem cells.My bone marrow is significantly scarred.I am not a candidate for organ transplant due to my health.My body is strong enough to handle treatment.My condition meets the specific disease criteria for the trial.I have 1 or 2 partially matched cord blood units for transplant.I have antibodies against donor tissues.I agree to use birth control if I can become pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: omidubicel
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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