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Stem Cell Transplantation

Stem Cell Transplantation with NiCord® for Blood Cancers

Phase 3

Waitlist Available

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 have one or two partially HLA-matched CBUs

Must not have

Prior allogeneic HSCT

HLA-matched donor able to donate

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 100 days post-transplant

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trialstudies transplanting NiCord® or cord blood cells to treat blood cancers like leukemia, myelodysplasia, or lymphoma.

Who is the study for?

This trial is for patients with certain blood cancers like leukemia or lymphoma who need a stem cell transplant and don't have a fully matched donor. They should be in good enough health to undergo the procedure, not pregnant, without active infections or other cancers, and have a back-up stem cell source.

What is being tested?

The study compares NiCord® (omidubicel), an advanced cord blood unit, with standard unmanipulated cord blood units for stem cell transplantation in patients with specific types of leukemia and lymphoma.

What are the potential side effects?

Potential side effects may include reactions related to the immune system's response to new cells, such as graft-versus-host disease, infection risks due to weakened immunity post-transplantation, infusion-related reactions, and complications from underlying conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have 1 or 2 partially matched cord blood units for transplant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a stem cell transplant from a donor.

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I have a donor who is a perfect match for me.

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I have symptoms related to a brain or spinal cord condition.

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I do not have any ongoing or uncontrolled infections.

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I have another active cancer besides the one being treated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 100 days post-transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~100 days post-transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and 100 days post-transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Neutrophil

Secondary study objectives

Days Alive and Out of Hospital in the First 100 Days Post-transplantation

Transplantation

Number of Participants With Platelet Engraftment by 42 Days Post-transplantation

Awards & Highlights

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.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: NiCord® (omidubicel)Experimental Treatment1 Intervention

NiCord® is a cryopreserved stem/progenitor cell based product comprised of: 1. ex vivo expanded, umbilical cord blood-derived hematopoietic CD34+ progenitor cells (NiCord® cultured fraction (CF)) 2. the non-cultured cell fraction of the same Cord Blood Unit (CBU) (NiCord® Non-cultured Fraction (NF)) consisting of mature myeloid and lymphoid cells. Both fractions, i.e. NiCord® CF and NiCord® NF, will be kept frozen until they are thawed and infused on the day of transplantation.

Group II: Unmanipulated CBU(s)Active Control1 Intervention

0 / 6Eligibility criteria met