Evidence map›Paper›PMID 34157093›Full record

Trial reportBlood2021

Omidubicel vs standard myeloablative umbilical cord blood transplantation: results of a phase 3 randomized study.

Mitchell E Horwitz, Patrick J Stiff, Corey Cutler, Claudio Brunstein, Rabi Hanna, Richard T Maziarz, Andrew R Rezvani, Nicole A Karris, Joseph McGuirk, David Valcarcel and 15 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in Blood, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02730299 (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), which is not on this map. Cited by 60 papers.

0numbers the graph read from it
0cells of the map it votes in
60citing papers in PubMed
10.7field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02730299 phase3completednot on this map

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

TypeinterventionalSponsorGamida Cell ltdRan2016 to 2025Enrolled125ConditionsHematological Malignancies, Acute Lymphoblastic Leukemia (ALL), Acute Myelogenous Leukemia (AML), Chronic Myelogenous Leukemia (CML)ArmsNiCord® (omidubicel), Cord Blood Unit
3 · Its place in the literature

Who cites it

60 citing papers in PubMed, 104 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Review
  5. Review
  6. Article
  7. Article
  8. From Donation to Innovation: New Blood-Derived Products.Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie · 2026
    Review
  9. Review
  10. Cryopreservation and Thawing ofJournal of hematology · 2026
    Article
  11. Review
  12. Review
  13. Article
  14. Donor selection, graft engineering, and dosing oh my!Hematology. American Society of Hematology. Education Program · 2025
    Review
  15. New age GVHD prophylaxis regimens: what works for what donor and why.Hematology. American Society of Hematology. Education Program · 2025
    Review
  16. Review
  17. Review
  18. Article
  19. Article
  20. Observational
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

25 authors at 20 institutions in 6 countries.

Mitchell E HorwitzDuke University Medical Center, Durham, NC.
Patrick J StiffLoyola University Medical Center, Chicago, IL.
Corey CutlerDana-Farber Cancer Institute, Boston MA.
Claudio BrunsteinUniversity of Minnesota, Minneapolis, MN.
Rabi HannaTaussig Cancer Institute, Department of Hematology & Medical Oncology, Cleveland Clinic, Cleveland, OH.
Richard T MaziarzOregon Health and Science University, Portland, OR.
Andrew R RezvaniStanford University Cancer Institute, Palo Alto, CA.
Nicole A KarrisCity of Hope, Duarte, CA.
Joseph McGuirkUniversity of Kansas Medical Center, Westwood, KS.ORCID 0000-0002-0539-4796
David ValcarcelDepartment of Hematology, University Hospital Vall d'Hebron, Barcelona, Spain.ORCID 0000-0002-8747-078X
Gary J SchillerDavid Geffen School of Medicine at University of California Los Angeles, Los Angeles, CA.
Caroline A LindemansPrinces Maxima Children's Hospital and the Department of Pediatrics, University Medical Center, University of Utrecht, Utrecht, The Netherlands.
William Y K HwangSingapore General Hospital, Singapore and National Cancer Centre of Singapore, Singapore.ORCID 0000-0003-0143-6263
Liang Piu KohNational University Cancer Institute, National University Health System Singapore, Singapore.
Amy KeatingChildrens Hospital Colorado, Aurora, CO.
Yasser KhaledMethodist University Hospital, Memphis, TN.
Nelson HamerschlakIsraelita Albert Einstein Hospital, Sao Paolo, Brazil.ORCID 0000-0002-5140-5310
Olga FrankfurtNorthwestern University, Chicago, IL.
Tony PeledGamida Cell, Jerusalem, Israel.
Irit SegalovichGamida Cell, Jerusalem, Israel.
Beth BlackwellEmmes Corporation, Rockville, MD.
Stephen WeaseEmmes Corporation, Rockville, MD.
Laurence S FreedmanGertner Institute for Epidemiology and Health Policy Research, Sheba Medical Center, Tel Hashomer, Israel; and.
Einat Galamidi-CohenGamida Cell, Jerusalem, Israel.
Guillermo SanzHematology Department, Hospital Universitari i Politècnic La Fe, Valencia, Spain.
Gamida Cell (Israel) · ILEmmes (United States) · USChildren's Hospital Colorado · USCity of Hope · USCleveland Clinic · USDana-Farber Cancer Institute · USDuke Medical Center · USHospital Israelita Albert Einstein · BRHospital Universitari i Politècnic La Fe · ESLoyola University Medical Center · USMethodist University Hospital · USNational University Cancer Institute, Singapore · SGNorthwestern University · USOregon Health & Science University · USPalo Alto Institute · USPrincess Máxima Center · NLSheba Medical Center · ILSingapore General Hospital · SGUniversity of California, Los Angeles · USUniversity of Kansas Medical Center · US

Funding

VIRUS PRODUCTION COREP30CA014051 · NCI · MASSACHUSETTS INSTITUTE OF TECHNOLOGY · PI Paula T Hammond · 1985 to 2026
$93.9M
NCI NIH HHS P30 CA014051
6 · The paper itself

Abstract

Omidubicel is an ex vivo expanded hematopoietic progenitor cell and nonexpanded myeloid and lymphoid cell product derived from a single umbilical cord blood unit. We report results of a phase 3 trial to evaluate the efficacy of omidubicel compared with standard umbilical cord blood transplantation (UCBT). Between January 2017 and January 2020, 125 patients age 13 to 65 years with hematologic malignancies were randomly assigned to omidubicel vs standard UCBT. Patients received myeloablative conditioning and prophylaxis with a calcineurin inhibitor and mycophenolate mofetil for graft-versus-host disease (GVHD). The primary end point was time to neutrophil engraftment. The treatment arms were well balanced and racially diverse. Median time to neutrophil engraftment was 12 days (95% confidence interval [CI], 10-14 days) for the omidubicel arm and 22 days (95% CI, 19-25 days) for the control arm (P < .001). The cumulative incidence of neutrophil engraftment was 96% for patients receiving omidubicel and 89% for patients receiving control transplants. The omidubicel arm had faster platelet recovery (55% vs 35% recovery by 42 days; P = .028), had a lower incidence of first grade 2 to 3 bacterial or invasive fungal infection (37% vs 57%; P = .027), and spent more time out of hospital during the first 100 days after transplant (median, 61 vs 48 days; P = .005) than controls. Differences in GVHD and survival between the 2 arms were not statistically significant. Transplantation with omidubicel results in faster hematopoietic recovery and reduces early transplant-related complications compared with standard UCBT. The results suggest that omidubicel may be considered as a new standard of care for adult patients eligible for UCBT. The trial was registered at www.clinicaltrials.gov as #NCT02730299.

Indexed as

AdolescentAdultCord Blood Stem Cell TransplantationFemaleFetal BloodGraft SurvivalGraft vs Host DiseaseHematologic NeoplasmsHematopoiesisHematopoietic Stem Cell TransplantationHumansMaleMiddle AgedYoung Adult

Identifiers

PMID34157093
PMCPMC9710469
OpenAlexW3176868674

What OpenQuestion holds

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Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.