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NCT02730299CompletedPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 25 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
125 (actual)
First submitted
28 Mar 2016
Start date
16 Dec 2016
Primary completion date
29 Apr 2021
Lead sponsor
Gamida Cell ltd
NCT number
NCT02730299

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 125
  • From 16 Dec 2016 to the primary completion date, 29 Apr 2021
  • 52 sites in 10 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior allogeneic HSCT

Other illness

  • Other active malignancy
  • Active or uncontrolled infection
  • Active/symptoms of central nervous system (CNS) disease

Other

  • HLA-matched donor able to donate
  • Pregnancy or lactation

Who the study is looking for

  • Applicable disease criteria
  • Patients must have one or two partially HLA-matched CBUs
  • Back-up stem cell source
  • Adequate Karnofsky/Lansky Performance score
  • Sufficient physiological reserves
  • Signed written informed consent

Age in the registry: 12 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (52)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA
Coordinator of this site? Confirm its status
Rio de JaneiroBrazilUnknown status
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
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São PauloBrazilUnknown status
Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
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São PauloBrazilUnknown status
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo Pediatrics
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São PauloBrazilUnknown status
Hospital Israelita Albert Einstein
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São PauloBrazilUnknown status
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainUnknown status
Sant Joan de Deu
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BarcelonaSpainUnknown status
Hospital Universitari Vall d'Hebron pediatrics
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BarcelonaSpainUnknown status
University Hospital Vall d'Hebron
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BarcelonaSpainUnknown status
ICO Bellvitge
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BarcelonaSpainUnknown status
Hospital Universitario Virgen del Rocio
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SevilleSpainUnknown status
Hospital Universitario la Fe
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ValenciaSpainUnknown status
Hospital Universitario y Politécnico La Fe (pediatric)
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ValenciaSpainUnknown status
Robert Debré
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ParisFranceUnknown status
Queen Elizabeth Hospital
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BirminghamUnited KingdomUnknown status
St James Hospital
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LeedsUnited KingdomUnknown status
Manchester University NHS Foundation Trust
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ManchesterUnited KingdomUnknown status
The Royal Marsden NHS Foundation Trust
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SuttonUnited KingdomUnknown status
Rambam
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HaifaIsraelUnknown status
Hadassah medical Center
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JerusalemIsraelUnknown status
Rabin Medical Center- Beilinson Hospital
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Petah TikvaIsraelUnknown status
Tel-Aviv Sourasky Medical Center
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Tel AvivIsraelUnknown status
Dana-Dwek Children's Hospital, Tel-Aviv Sourasky Medical Center
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Tel AvivIsraelUnknown status
Chaim Sheba Medical Center, The Edmond and Lily Safra Children's hospital
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Tel HaShomerIsraelUnknown status
Careggi University Hospital
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FlorenceItalyUnknown status
Ospedale Pediatrico Bambino Gesù
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RomeItalyUnknown status
Prinses Maxima Centrum voor Kinderoncologie B.V.
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UtrechtNetherlandsUnknown status
University Medical Center Utrecht
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UtrechtNetherlandsUnknown status
Instituto Português de Oncologia de Lisboa Francisco Gentil
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LisbonPortugalUnknown status
National University Cancer Institute
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SingaporeSingaporeUnknown status
Singapore General Hospital
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SingaporeSingaporeUnknown status
The University of Maryland Medicine Center
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BaltimoreUnited StatesUnknown status
Boston Children's Hospital
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BostonUnited StatesUnknown status
Dana-Farber Cancer Institute
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BostonUnited StatesUnknown status
University of Virginia Cancer Center
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CharlottesvilleUnited StatesUnknown status
Cleveland Clinic Children's
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ClevelandUnited StatesUnknown status
Children's Medical Center of Dallas
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DallasUnited StatesUnknown status
Children's Hospital Colorado
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DenverUnited StatesUnknown status
Henry Ford Medical Center
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DetroitUnited StatesUnknown status
Duke University Medical Center
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DurhamUnited StatesUnknown status
Northwestern University
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EvanstonUnited StatesUnknown status
West Cancer Clinic
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GermantownUnited StatesUnknown status
UCLA
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Los AngelesUnited StatesUnknown status
City of Hope
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Los AngelesUnited StatesUnknown status
Loyola University, Cardinal Bernardin Cancer Center
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MaywoodUnited StatesUnknown status
University of Minnesota/Masonic Cancer Center
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MinneapolisUnited StatesUnknown status
Rutgers Cancer Institute of New Jersey
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New BrunswickUnited StatesUnknown status
Stanford University Cancer Institute
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Palo AltoUnited StatesUnknown status
UPMC Children's Hospital of Pittsburgh
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PittsburghUnited StatesUnknown status
Oregon Health Science University
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PortlandUnited StatesUnknown status
UC San Diego Moores Cancer Center
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San DiegoUnited StatesUnknown status
University of Kansas Cancer Center
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WestwoodUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.