NCT02039557

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2014

Longer than P75 for all trials

Geographic Reach
4 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 17, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2023

Completed
Last Updated

October 23, 2024

Status Verified

October 1, 2024

Enrollment Period

9.2 years

First QC Date

January 13, 2014

Last Update Submit

October 22, 2024

Conditions

Patients Transplanted With NiCord/CordIn (Omidubicel)

Outcome Measures

Primary Outcomes (1)

  • long term sustained chimerism of NiCord®/CordIn™ (omidubicel) transplantation

    5 years

Study Arms (1)

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)

Interventions

NiCord®/CordIn™ (omidubicel)GENETIC
NiCord®/CordIn™ (omidubicel) transplanted

Eligibility Criteria

Age2 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

UCSF Benioff Children's Hospital

Oakland, California, 94609, United States

Location

Loyola University, Cardinal Bernardin Cancer Center

Maywood, Illinois, 60153, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Vanderbilt

Nashville, Tennessee, 37240, United States

Location

University Medical Center Utrecht

Utrecht, 3503 AB, Netherlands

Location

National University Cancer Institute

Singapore, 119074, Singapore

Location

Singapore General Hospital

Singapore, 169608, Singapore

Location

University Hospital Vall D'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario La Fe

Valencia, 46009, Spain

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2014

First Posted

January 17, 2014

Study Start

May 1, 2014

Primary Completion

June 29, 2023

Study Completion

June 29, 2023

Last Updated

October 23, 2024

Record last verified: 2024-10

Locations

ES(2)US(5)NL(1)SG(2)