Allogeneic SCT of CordIn™, in Patients With Hemoglobinopathies

Stopped early · Phase 1/Phase 2

Conditions studied: Sickle Cell Disease, Thalassemia

In brief

CordIn™ is a cryopreserved stem/progenitor cell-based product of purified CD133+ cells composed of ex vivo expanded allogeneic UCB cells. The overall study objectives are to evaluate the safety and efficacy of CordIn™.

Key facts

Study ID

NCT02504619

Run by

Gamida Cell ltd

People needed

1

Starts

2016-04-04

Expected to finish

2017-12-01

Last updated by the study team

2019-06-26

Who can join

Age: 2 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is a candidate for allogeneic SCT for treatment of SCD or thalassemia
• Patients must have one partially HLA-matched CBUs
• Adequate Karnofsky Performance score or Lansky Play-Performance scale
• Sufficient physiological reserves
• Signed written informed consent

You may not qualify if…

• Prior allogeneic HSCT
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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