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Clinical trialNCT02730299CompletedPhase 3Interventional

Stem Cell Transplantation With NiCord® (Omidubicel) vs Standard UCB in Patients With Leukemia, Lymphoma, and MDS

SponsorGamida Cell ltdEnrollment125Acute LeukemiaAcute Lymphoblastic Leukemia (ALL)Acute Myelogenous Leukemia (AML)Chronic Myelogenous Leukemia (CML)Hematological MalignanciesLymphoma+1 more conditions
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

52 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Brazil
  • Instituto Nacional de Câncer José Alencar Gomes Da Silva - Inca

    Rio de Janeiro, Rio de Janeiro, Brazil

  • Hospital Das Clínicas Da Faculdade de Medicina Da Universidade de São Paulo

    São Paulo, São Paulo, Brazil

  • Hospital Das Clínicas Da Faculdade de Medicina Da Universidade de São Paulo Pediatrics

    São Paulo, São Paulo, Brazil

  • Hospital Das Clínicas Da Faculdade de Medicina de Ribeirão Preto Da Universidade de São Paulo

    São Paulo, São Paulo, Brazil

  • Hospital Israelita Albert Einstein

    São Paulo, Brazil

France
  • Robert Debré

    Paris, France

Israel
  • Rambam

    Haifa, Israel

  • Hadassah Medical Center

    Jerusalem, Israel

  • Rabin Medical Center, Beilinson Hospital

    Petah Tikva, Israel

  • Dana-Dwek Children'S Hospital, Tel-Aviv Sourasky Medical Center

    Tel Aviv, Israel

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv, Israel

  • Chaim Sheba Medical Center, the Edmond and Lily Safra Children'S Hospital

    Tel Litwinsky, Israel

Italy
  • Careggi University Hospital

    Florence, Italy

  • Ospedale Pediatrico Bambino Gesù

    Rome, Italy

Netherlands
  • Prinses Maxima Centrum Voor Kinderoncologie B.V.

    Utrecht, Netherlands

  • University Medical Center Utrecht

    Utrecht, Netherlands

Portugal
  • Instituto Português de Oncologia de Lisboa Francisco Gentil

    Lisbon, Portugal

Singapore
  • National University Cancer Institute

    Singapore, Singapore

  • Singapore General Hospital

    Singapore, Singapore

Spain
  • Hospital Universitari Vall D'Hebron Pediatrics

    Barcelona, Spain

  • Hospital de la Santa Creu I Sant Pau

    Barcelona, Spain

  • Ico Bellvitge

    Barcelona, Spain

  • Sant Joan de Deu

    Barcelona, Spain

  • University Hospital Vall D'Hebron

    Barcelona, Spain

  • Hospital Universitario Virgen del Rocío

    Seville, Spain

  • Hospital Universitario la Fe

    Valencia, Spain

  • Hospital Universitario Y Politécnico la Fe (pediatric)

    Valencia, Spain

United Kingdom
  • the Royal Marsden Nhs Foundation Trust

    Sutton, Surrey, United Kingdom

  • Queen Elizabeth Hospital

    Birmingham, United Kingdom

  • St James Hospital

    Leeds, United Kingdom

  • Manchester University Nhs Foundation Trust

    Manchester, United Kingdom

United States
  • City of Hope

    Los Angeles, California, United States

  • Ucla

    Los Angeles, California, United States

  • Stanford University Cancer Institute

    Palo Alto, California, United States

  • Uc San Diego Moores Cancer Center

    San Diego, California, United States

  • Children'S Hospital Colorado

    Denver, Colorado, United States

  • Northwestern University

    Evanston, Illinois, United States

  • Loyola University, Cardinal Bernardin Cancer Center

    Maywood, Illinois, United States

  • University of Kansas Cancer Center

    Westwood, Kansas, United States

  • the University of Maryland Medicine Center

    Baltimore, Maryland, United States

12 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

NiCord®
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
16 Dec 2016
Primary completion
29 Apr 2021
Completion
7 Feb 2025
Last update posted
25 Feb 2026
Registered enrollment
125
Registry id
NCT02730299

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.