← Back to Search

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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and by day 42 post-transplant inclusive for reporting.

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Gamida Cell ltdLead Sponsor

8 Previous Clinical Trials

340 Total Patients Enrolled

Mitchell Horwitz, MDPrincipal InvestigatorDuke University

12 Previous Clinical Trials

370 Total Patients Enrolled

Media Library

Omidubicel (Stem Cell Transplant) Clinical Trial Eligibility Overview. Trial Name: NCT04260698 — Phase 3

Blood Cancers Research Study Groups: omidubicel

Blood Cancers Clinical Trial 2023: Omidubicel Highlights & Side Effects. Trial Name: NCT04260698 — Phase 3

Omidubicel (Stem Cell Transplant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04260698 — Phase 3

Frequently Asked Questions

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

Is there a high potential for omidubicel to cause harm to patients?

"There is some clinical data supporting omidubicel's efficacy, and it has received multiple rounds of safety testing, so our team at Power has given it a score of 3."

Answered by AI

Are there any more patients needed for this experiment?

"Yes, this research is still looking for volunteers according to the latest update on clinicaltrials.gov. The posting went up on July 8th, 2020 and was most recently updated on June 9th, 2022."

Answered by AI

What is the total volume of patients who can participate in this clinical trial?

"Sixty volunteers are needed for this clinical study. Those who meet the eligibility requirements and live near the participating sites, which include UCLA in Los Angeles and Loyola University's Cardinal Bernardin Cancer Center in Maywood, Illinois, can sign up to participate."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "Expanded Access of Omidubicel, for Allogeneic Transplantation in Patients With Hematological Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04260698.