Patients Transplanted With NiCord/CordIn (Omidubicel)NCT02039557
Long Term Follow Up Protocol for NiCord®/CordIn™ (Omidubicel) Patients
An observational study of Patients Transplanted With NiCord/CordIn (Omidubicel), run by Gamida Cell ltd at 10 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 65 years
- Conditions the study is for
- Patients Transplanted With NiCord/CordIn (Omidubicel)
- What is being tested?
- NiCord®/CordIn™ (omidubicel)
- Type of treatment
- Injection or infusion
- How many people
- 33 participants
- Where
- 10 sitesin 4 countries
- Study dates
- 1 May 2014to 29 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: NiCord® (ages 12-65)/CordIn™ (ages 2-25) (omidubicel) transplanted patients
Who may be able to join
- Anyone who has received a NiCord®/CordIn™ (omidubicel) transplant, completed study specific follow up, and has signed the consent for this study.
Who cannot join
- None
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
United States5 sites
Duke University Medical Center
Durham, North Carolina, 27705
Duke University Medical Center
Durham, North Carolina, 27710
Loyola University, Cardinal Bernardin Cancer Center
Maywood, Illinois, 60153
Vanderbilt
Nashville, Tennessee, 37240
UCSF Benioff Children's Hospital
Oakland, California, 94609
Singapore2 sites
National University Cancer Institute
Singapore, 119074
Singapore General Hospital
Singapore, 169608
Spain2 sites
University Hospital Vall D'Hebron
Barcelona, 08035
Hospital Universitario La Fe
Valencia, 46009
About this study
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
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.
- Being tested
- NiCord®/CordIn™ (omidubicel)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NiCord®/CordIn™ (omidubicel)Genetic
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Genetic: NiCord®/CordIn™ (omidubicel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
long term sustained chimerism of NiCord®/CordIn™ (omidubicel) transplantation
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2014 (estimated)
- Study start1 May 2014
- Primary completion29 Jun 2023
- Study completion29 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Transplanted With NiCord/CordIn (Omidubicel)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gamida Cell ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02039557
- Sponsor's protocol ID
- GC P# 04.01.020/030
- Status last verified
- Oct 2024
- First submitted
- 13 Jan 2014
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02039557
- Acronym / sponsor ID
- GC P# 04.01.020/030
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Gamida Cell ltdIndustry (pharma, biotech, devices)
- Study start
- 1 May 2014 (actual)
- Primary completion
- 29 Jun 2023 (actual)
- Study completion
- 29 Jun 2023 (actual)
- First posted
- 17 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NiCord®/CordIn™ (omidubicel) transplanted | – | Genetic: NiCord®/CordIn™ (omidubicel)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. |
Who may qualify
- Ages
- 2 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- NiCord® (ages 12-65)/CordIn™ (ages 2-25) (omidubicel) transplanted patients
Key inclusion criteria (1 listed)
- Anyone who has received a NiCord®/CordIn™ (omidubicel) transplant, completed study specific follow up, and has signed the consent for this study.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NiCord®/CordIn™ (omidubicel) | Genetic | NiCord®/CordIn™ (omidubicel) transplanted |
Primary outcome
long term sustained chimerism of NiCord®/CordIn™ (omidubicel) transplantation
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Transplanted With NiCord/CordIn (Omidubicel), run by Gamida Cell ltd at 10 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Singapore, Spain, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
long term sustained chimerism of NiCord®/CordIn™ (omidubicel) transplantation (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.