CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 125 enrolled
Drug / intervention
NiCord® (omidubicel) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02730299
NCT02730299Phase 3Completed

A Multicenter, Randomized, Phase III Registration Trial of Transplantation of NiCord®, Ex Vivo Expanded, UCB-derived, Stem and Progenitor Cells, vs. Unmanipulated UCB for Patients With Hematological Malignancies

Gamida Cell ltd·interventional·Posted Apr 6, 2016·Updated Feb 25, 2026

In Brief

A Phase 3 clinical trial evaluating NiCord® (omidubicel) and Cord Blood Unit for Hematological Malignancies and 6 related conditions. Completed, enrolled 125 participants across 52 sites in 10 countries.

Detailed Summary

This study is an open-label, controlled, multicenter, international, Phase III, randomized study of transplantation of NiCord® versus transplantation of one or two unmanipulated, unrelated cord blood units in patients with acute lymphoblastic leukemia or acute myeloid leukemia, myelodysplastic syndrome, chronic myeloid leukemia or lymphoma, all with required disease features rendering them eligible for allogeneic transplantation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil, France, Israel, Italy, Netherlands, Portugal, Singapore, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 6, 2016
Enrollment StartDec 16, 2016
Primary CompletionApr 29, 2021
Study CompletionFeb 7, 2025
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 10.2 years ago

Interventions

NiCord® (omidubicel)drug

Cord Blood Unitother

Cord blood unit