Long Term Follow Up Protocol for NiCord®/CordIn™ (Omidubi... | NCT02039557

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

NCT02039557

Sponsor

Gamida Cell ltd

Status

Completed

Last Update Posted

Oct 23, 2024Actual

Enrollment

33Actual

Phase

Not provided

Conditions

Patients Transplanted With NiCord/CordIn (Omidubicel)

Interventions

NiCord®/CordIn™ (omidubicel)

Countries

United States
Netherlands
Singapore
Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2014Actual

Primary Completion Date

Jun 29, 2023Actual

Completion Date

Jun 29, 2023Actual

First Submitted Date

Jan 13, 2014

First Submission Date that Met QC Criteria

Jan 15, 2014

First Posted Date

Jan 17, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 22, 2024

Last Update Posted Date

Oct 23, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

33Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
NiCord®/CordIn™ (omidubicel)	Genetic		NiCord®/CordIn™ (omidubicel) transplanted

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UCSF Benioff Children's Hospital		Oakland	California	94609	United States
Loyola University, Cardinal Bernardin Cancer Center