Allogeneic SCT of CordIn™, in Patients With Hemoglobinopathies
NCT ID: NCT02504619
Last Updated: 2019-06-26
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE1/PHASE2
1 participants
INTERVENTIONAL
2016-04-04
2017-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Allogeneic SCT of NiCord®, UCB-Derived Ex Vivo Expanded Stem and Progenitor Cells, in Patients With Hemoglobinopathies
NCT01590628
US Phase I Study of ECT-001-CB in Patients With Sickle-Cell Disease
NCT04594031
Cord Blood Transplantation for Sickle Cell Anemia and Thalassemia
NCT00029380
Collection and Storage of Umbilical Cord Stem Cells for Treatment of Sickle Cell Disease
NCT00012545
A Blood Stem Cell Transplant for Sickle Cell Disease
NCT03249831
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The trial ends when the last patient completes their last visit. The overall study objectives are to evaluate the safety and efficacy of CordIn™: single ex-vivo expanded cord blood unit transplantation in patients with hemoglobinopathies (sickle cell disease or thalassemia major) following a preparative therapy.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CordIn
Transplantation of CordIn
CordIn
CordIn™ is a cryopreserved stem/progenitor cell-based product of purified CD133+ cells composed of ex vivo expanded allogeneic UCB cells.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CordIn
CordIn™ is a cryopreserved stem/progenitor cell-based product of purified CD133+ cells composed of ex vivo expanded allogeneic UCB cells.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients must have one partially HLA-matched CBUs
* Adequate Karnofsky Performance score or Lansky Play-Performance scale
* Sufficient physiological reserves
* Signed written informed consent
Exclusion Criteria
* Evidence of HIV infection or HIV positive serology
* Evidence of active Hepatitis B, Hepatitis C or EBV as determined by serology or PCR
* Active or uncontrolled infection
* Pregnancy or lactation
2 Years
25 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Gamida Cell ltd
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jean-Hugues Dalle, MD
Role: PRINCIPAL_INVESTIGATOR
Robert Debre, Paris, France
Franco Locatelli, MD
Role: PRINCIPAL_INVESTIGATOR
IRCCS Ospedale Pediatrico Bambino Gesu, Rome, Italy
Allistair Abraham, MD
Role: PRINCIPAL_INVESTIGATOR
Children's National, Washington DC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UCSF Benioff Children's Hospital
Oakland, California, United States
Children's National
Washington D.C., District of Columbia, United States
Hôpital Robert Debré
Paris, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GC P#01.01.030
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.