We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02039557
Recruitment Status : Active, not recruiting
First Posted : January 17, 2014
Last Update Posted : November 1, 2022
Information provided by (Responsible Party):
Gamida Cell ltd

Brief Summary:
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.

Condition or disease Intervention/treatment
Patients Transplanted With NiCord/CordIn (Omidubicel) Genetic: NiCord®/CordIn™ (omidubicel)

Layout table for study information
Study Type : Observational
Actual Enrollment : 32 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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
Actual Study Start Date : May 1, 2014
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

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)

Primary Outcome Measures :
  1. long term sustained chimerism of NiCord®/CordIn™ (omidubicel) transplantation [ Time Frame: 5 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   2 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
NiCord® (ages 12-65)/CordIn™ (ages 2-25) (omidubicel) transplanted patients

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02039557

Layout table for location information
United States, California
UCSF Benioff Children's Hospital
Oakland, California, United States, 94609
United States, Illinois
Loyola University, Cardinal Bernardin Cancer Center
Maywood, Illinois, United States, 60153
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Tennessee
Nashville, Tennessee, United States, 37240
University Medical Center Utrecht
Utrecht, Netherlands, 3503 AB
National University Cancer Institute
Singapore, Singapore, 119074
Singapore General Hospital
Singapore, Singapore, 169608
University Hospital Vall D'Hebron
Barcelona, Spain, 08035
Hospital Universitario La Fe
Valencia, Spain, 46009
Sponsors and Collaborators
Gamida Cell ltd
Layout table for additonal information
Responsible Party: Gamida Cell ltd
ClinicalTrials.gov Identifier: NCT02039557    
Other Study ID Numbers: GC P# 04.01.020/030
First Posted: January 17, 2014    Key Record Dates
Last Update Posted: November 1, 2022
Last Verified: October 2022