Clinical Trial: Allogeneic SCT of CordIn™, in Patients With Hemoglobinopathies
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Allogeneic Stem Cell Transplantation of CordIn™, Umbilical Cord Blood-Derived Ex Vivo Expanded Stem and Progenitor Cells, in Patients With Hemoglobinopathies
Brief 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™.
Detailed Summary:
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.
Sponsor: Gamida Cell ltd
Current Primary Outcome:
- The acute toxicities associated with the infusion of CordIn, within 24 hours post-infusion. [ Time Frame: 24 hours ]
- The proportion of patients with donor-derived engraftment at 42 days following transplantation [ Time Frame: 42 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Overall survival at 365 days after transplantation [ Time Frame: 365 days ]
Original Secondary Outcome: Same as current
Information By: Gamida Cell ltd
Dates:
Date Received: January 21, 2015
Date Started: May 2015
Date Completion: September 2018
Last Updated: May 24, 2017
Last Verified: September 2016
