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Summary

for people ages 2–25 (full criteria)
at Oakland, California and other locations
study started
estimated completion:
Mark Walters

Description

Summary

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™.

Official Title

Allogeneic Stem Cell Transplantation of CordIn™, Umbilical Cord Blood-Derived Ex Vivo Expanded Stem and Progenitor Cells, in Patients With Hemoglobinopathies

Details

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.

Keywords

Sickle Cell Disease Thalassemia

Eligibility

You can join if…

Open to people ages 2–25

  • 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 CAN'T join 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

Locations

  • Children's National accepting new patients
    Washington, D.C., District of Columbia, 20010, United States
  • Hôpital Robert Debré accepting new patients
    Paris, France

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gamida Cell ltd
ID
NCT02504619
Phase
Phase 1/2
Lead Scientist
Mark Walters
Study Type
Interventional
Last Updated
September 12, 2016
I’m interested in this study!