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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
Sponsor:
Information provided by (Responsible Party):
Gamida Cell ltd

Tracking Information
First Submitted Date January 13, 2014
First Posted Date January 17, 2014
Last Update Posted Date November 1, 2022
Actual Study Start Date May 1, 2014
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 12, 2022)
long term sustained chimerism of NiCord®/CordIn™ (omidubicel) transplantation [ Time Frame: 5 years ]
Original Primary Outcome Measures
 (submitted: January 15, 2014)
long term sustained engraftment of NiCord® transplantation [ Time Frame: 5 years ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Long Term Follow Up Protocol for NiCord®/CordIn™ (Omidubicel) Patients
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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population NiCord® (ages 12-65)/CordIn™ (ages 2-25) (omidubicel) transplanted patients
Condition Patients Transplanted With NiCord/CordIn (Omidubicel)
Intervention Genetic: NiCord®/CordIn™ (omidubicel)
Study Groups/Cohorts 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.
Intervention: Genetic: NiCord®/CordIn™ (omidubicel)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: May 13, 2020)
32
Original Estimated Enrollment
 (submitted: January 15, 2014)
50
Estimated Study Completion Date July 2023
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands,   Singapore,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02039557
Other Study ID Numbers GC P# 04.01.020/030
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Gamida Cell ltd
Original Responsible Party Same as current
Current Study Sponsor Gamida Cell ltd
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Gamida Cell ltd
Verification Date October 2022