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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 100 days post-transplant

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Neutrophil

Secondary outcome measures

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

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: ex vivo expanded, umbilical cord blood-derived hematopoietic CD34+ progenitor cells (NiCord® cultured fraction (CF)) 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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Gamida Cell ltdLead Sponsor

8 Previous Clinical Trials

251 Total Patients Enrolled

Mitchell Horwitz, MDStudy ChairDuke University

12 Previous Clinical Trials

281 Total Patients Enrolled

Media Library

NiCord® (Omidubicel) (Stem Cell Transplantation) Clinical Trial Eligibility Overview. Trial Name: NCT02730299 — Phase 3

Blood Cancers Research Study Groups: Unmanipulated CBU(s), NiCord® (omidubicel)

Blood Cancers Clinical Trial 2023: NiCord® (Omidubicel) Highlights & Side Effects. Trial Name: NCT02730299 — Phase 3

NiCord® (Omidubicel) (Stem Cell Transplantation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02730299 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA cleared NiCord® (omidubicel) for public use?

"There is both preclinical and clinical evidence supporting the safety of NiCord®, leading to a score of 3."

Answered by AI

Which patients would be the best candidates for this clinical trial?

"Individuals between the ages of 12 and 65 that suffer from muscular dystrophy are encouraged to apply to this study. The researchers are looking to have around 125 total participants."

Answered by AI

If a patient is older than 35, can they still participate in this research study?

"In order to participate in this clinical trial, patients must be between the ages of 12 and 65. There are 1290 other trials available for patients that are younger and 5714 for those that are older."

Answered by AI

Are people with the condition still being recruited for the trial?

"This particular clinical trial is not recruiting patients at the moment, as per the information found on clinicaltrials.gov. The trial was originally posted on December 16th, 2016, and was edited most recently on October 24th, 2022. There are 6685 other trials that are currently recruiting participants."

Answered by AI

Is this trial taking place across a broad geographical area in North America?

"Currently, patients are being accepted at the University of Kansas Cancer Center in Westwood, Kansas, Rutgers Cancer Institute of New jersey in New Brunswick, New Jersey, and UPMC Children's Hospital of Pittsburgh in Pittsburgh, Pennsylvania. In addition, there are 21 other locations where this trial is being conducted."

Answered by AI

Recent research and studies

The Lancet HaematologyJournal

47th Annual Meeting of the EBMT

del Pozo Martín, Yaiza. 2021. “47th Annual Meeting of the EBMT”. The Lancet Haematology. Elsevier BV. doi:10.1016/s2352-3026(21)00104-6.

clinicaltrials.govStudy

Stem Cell Transplantation With NiCord® (Omidubicel) vs Standard UCB in Patients With Leukemia, Lymphoma, and MDS

2016. "Stem Cell Transplantation With NiCord® (Omidubicel) vs Standard UCB in Patients With Leukemia, Lymphoma, and MDS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02730299.

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