Allogeneic SCT of CordIn™, in Patients With Hemoglobinopathies

Gamida Cell

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Thalassemia

Sickle Cell Disease

Treatments

Biological: CordIn

Study type

Interventional

Funder types

Industry

Identifiers

NCT02504619

GC P#01.01.030

Details and patient eligibility

About

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™.

Full description

CordIn™ is a cryopreserved stem/progenitor cell-based product of purified CD133+ cells composed of ex vivo expanded allogeneic UCB cells.

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.

Enrollment

1 patient

Sex

All

Ages

2 to 25 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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