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

NCT ID: NCT02039557

Last Updated: 2024-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-01

Study Completion Date

2023-06-29

Brief Summary

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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

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Conditions

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Patients Transplanted With NiCord/CordIn (Omidubicel)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

NiCord®/CordIn™ (omidubicel)

Intervention Type GENETIC

Interventions

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NiCord®/CordIn™ (omidubicel)

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gamida Cell ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UCSF Benioff Children's Hospital

Oakland, California, United States

Site Status

Loyola University, Cardinal Bernardin Cancer Center

Maywood, Illinois, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Vanderbilt

Nashville, Tennessee, United States

Site Status

University Medical Center Utrecht

Utrecht, , Netherlands

Site Status

National University Cancer Institute

Singapore, , Singapore

Site Status

Singapore General Hospital

Singapore, , Singapore

Site Status

University Hospital Vall D'Hebron

Barcelona, , Spain

Site Status

Hospital Universitario La Fe

Valencia, , Spain

Site Status

Countries

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United States Netherlands Singapore Spain

Other Identifiers

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GC P# 04.01.020/030

Identifier Type: -

Identifier Source: org_study_id

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