Long Term Follow Up Protocol for NiCord®/CordIn™ (Omidubicel) Patients

October 22, 2024 updated by: Gamida Cell ltd

Long Term Follow Up for Patients Who Have Received Allogeneic Stem Cell Transplantation of NiCord®/CordIn™, Umbilical Cord Blood-derived Ex Vivo Expanded Stem and Progenitor Cells

This is an observational study that will monitor clinical outcomes of patients who have received a NiCord®/CordIn™ (omidubicel) transplant as part of a GC clinical interventional study and meet the eligibility criteria for this Long Term Follow Up study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

33

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Utrecht, Netherlands, 3503 AB
        • University Medical Center Utrecht
  • Singapore
      • Singapore, Singapore, 169608
        • Singapore General Hospital
      • Singapore, Singapore, 119074
        • National University Cancer Institute
  • Spain
      • Barcelona, Spain, 08035
        • University Hospital Vall d'Hebron
      • Valencia, Spain, 46009
        • Hospital Universitario la Fe
  • United States
    • California
      • Oakland, California, United States, 94609
        • UCSF Benioff Children's Hospital
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University, Cardinal Bernardin Cancer Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37240
        • Vanderbilt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

NiCord® (ages 12-65)/CordIn™ (ages 2-25) (omidubicel) transplanted patients

Description

Inclusion Criteria

  • Anyone who has received a NiCord®/CordIn™ (omidubicel) transplant, completed study specific follow up, and has signed the consent for this study.

Exclusion Criteria

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
NiCord®/CordIn™ (omidubicel) transplanted
Anyone who signed the consent for this study received a NiCord®/CordIn™ (omidubicel) infusion as part of a GC clinical interventional study, and completed the interventional study Day 365 status assessment.
Genetic: NiCord®/CordIn™ (omidubicel)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
long term sustained chimerism of NiCord®/CordIn™ (omidubicel) transplantation
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gamida Cell ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2014

Primary Completion (Actual)

June 29, 2023

Study Completion (Actual)

June 29, 2023

Study Registration Dates

First Submitted

January 13, 2014

First Submitted That Met QC Criteria

January 15, 2014

First Posted (Estimated)

January 17, 2014

Study Record Updates

Last Update Posted (Actual)

October 23, 2024

Last Update Submitted That Met QC Criteria

October 22, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • GC P# 04.01.020/030

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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