A Multicenter, Randomized, Phase III Registration Trial of Transplantation of NiCord®, Ex Vivo Expanded, Umbilical Cord Blood-derived, Stem and Progenitor Cells, versus Unmanipulated Umbilical Cord Blood for Patients with Hematological Malignancies | Aplastic Anemia & MDS International Foundation

ClinicalTrials.gov Identifier:

NCT02730299

Company

Gamida Cell Ltd.

Contact Info

Kelly Myers

clinicaltrials@gamida-cell.com

+972-2-6595631

Dates

Start: November 2016
End: December 2020

Official Title

A Multicenter, Randomized, Phase III Registration Trial of Transplantation of NiCord®, Ex Vivo Expanded, Umbilical Cord Blood-derived, Stem and Progenitor Cells, versus Unmanipulated Umbilical Cord Blood for Patients with Hematological Malignancies

Purpose

This study is an open-label, controlled, multicenter, international, Phase III, randomized study comparing transplantation of Omidubicel/ NiCord® to transplantation of one or two unmanipulated, unrelated cord blood units in patients with hematological malignancies for whom allogenic SCT is currently a recommended and potentially lifesaving treatment (all with required disease features rendering them eligible for allogeneic transplantation).

A Multicenter, Randomized, Phase III Registration Trial of Transplantation of NiCord®, Ex Vivo Expanded, Umbilical Cord Blood-derived, Stem and Progenitor Cells, versus Unmanipulated Umbilical Cord Blood for Patients with Hematological Malignancies

Clinical Trial: NCT02730299

Instructions

If you are interested in learning more about your possible participation in this clinical trial, please complete the form. Your information will be forwarded directly to the sponsoring company.

Status: 
Recruiting
Phase: 
Phase 3
Gender: 
Female
Male
Age Group: 
12 years to 65 years
Accepts Healthy Volunteers: 
No
Inclusion Criteria: 
  • Applicable disease criteria
  • Patients must have one or two partially HLA-matched CBUs
  • Adequate Karnofsky/Lansky Performance score
  • Sufficient physiological reserves
  • Signed written informed consent
Exclusion Criteria: 
  • HLA fully matched donor able to donate
  • Prior allogeneic HSCT
  • Other active malignancy
  • Active or uncontrolled infection
  • Active/symptoms of central nervous system (CNS) disease
  • Pregnancy or lactation

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