Evidence map›Paper›PMID 20952687›Full record

ArticleBlood2011

Infusion of ex vivo expanded T regulatory cells in adults transplanted with umbilical cord blood: safety profile and detection kinetics.

Claudio G Brunstein, Jeffrey S Miller, Qing Cao, David H McKenna, Keli L Hippen, Julie Curtsinger, Todd Defor, Bruce L Levine, Carl H June, Pablo Rubinstein and 3 more

7 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase I
In one paragraph

Article in Blood, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 7 registered trials, which are not on this map. Cited by 582 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
582citing papers in PubMed, 1 pooled it
40.0field-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.

NCT03011021 phase1 / phase2unknown statusstarted 2017, after this paper: background citation

Phase 1/ Phase 2 Study of the Therapeutic Effect of Ex-vivo Expanded Umbilical Cord Blood Regulatory T Cells With Liraglutide on Autoimmune Diabetes

Ran2017Enrolled40Registered outcomes9Posted comparisons0ConditionsAutoimmune Diabetes, Type1 Diabetes MellitusArmsInsulin, liraglutide, UCB-Treg
Open the trial in the graph
NCT00602693 phase1completednot on this map

Phase I Study of Infusion of Umbilical Cord Blood (UCB) Derived CD25+CD4+ T-Regulatory (Treg) Cells After Nonmyeloablative Cord Blood Transplantation

TypeinterventionalSponsorMasonic Cancer Center, University of MinnesotaRan2007 to 2015Enrolled41ConditionsLeukemia, Lymphoma, Multiple Myeloma, Plasma Cell NeoplasmArmsumbilical cord blood transplantation, Allopurinol, fludarabine phosphate, Cyclophosphamide, Total body irradiation
NCT02338232 naterminatednot on this mapstarted 2015, after this paper: background citation

Pilot Study of Telmisartan (Micardis) For the Prevention of Acute Graft vs. Host Disease Post Allogeneic Hematopoietic Stem Cell Transplantation

TypeinterventionalSponsorHackensack Meridian HealthRan2015 to 2023Enrolled32ConditionsGVHDArmsTelmisartan
NCT02932826 phase1 / phase2unknown statusnot on this mapstarted 2016, after this paper: background citation

Phase 1/ Phase 2 Study of the Therapeutic Effect of Ex-vivo Expanded Umbilical Cord Blood Regulatory T Cells on Autoimmune Diabetes

TypeinterventionalSponsorSecond Xiangya Hospital of Central South UniversityRan2016 to 2025Enrolled40ConditionsDiabetes Mellitus, Type 1ArmsUmbilical Cord Blood Regulatory T cells Therapy, Insulin
NCT05423691 phase1recruitingnot on this mapstarted 2022, after this paper: background citation

Phase Ib, Open-label Study of Add on Therapy With CK0804 in Participants With Myelofibrosis, With Suboptimal Response to Ruxolitinib

TypeinterventionalSponsorCellenkos, Inc.Ran2022 to 2026Enrolled24ConditionsMyelofibrosisArmsCK0804
NCT05695521 phase1active not recruitingnot on this mapstarted 2023, after this paper: background citation

Phase 1 Safety Run-in Study and Phase 1b Randomized, Double Blinded, Placebo Controlled Trial

TypeinterventionalSponsorCellenkos, Inc.Ran2023 to 2027Enrolled66ConditionsAmyotrophic Lateral SclerosisArmsCK0803, Excipient
NCT07576699 phase1 / phase2not yet recruitingnot on this mapstarted 2026, after this paper: background citation

CK0802 for Treatment of Steroid Refractory Graft vs. Host Disease (GVHD)

TypeinterventionalSponsorCellenkos, Inc.Ran2026 to 2029Enrolled12ConditionsSteroid Refractory Graft Versus Host DiseaseArmsCK0802 (Allogeneic, Cryopreserved, Cord blood-derived T-regulatory cells, cells that are not HLA matched)
3 · Its place in the literature

Who cites it

582 citing papers in PubMed, 1 synthesis or guideline pooled it, 1,019 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Pharmacokinetics, lineage identity, and trafficking of ex vivo expanded polyclonal regulatory T cells in a prospective randomized clinical trial of kidney transplant recipients with allograft inflammation.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2026
    Trial
  4. Regulatory T cells: From Foxp3 to tolerance-inducing therapies.The Journal of investigative dermatology · 2026
    Review
  5. Review
  6. Article
  7. Review
  8. Article
  9. Review
  10. Decoding TNF receptor superfamily control of CD4Cell communication and signaling : CCS · 2026
    Review
  11. Article
  12. Review
  13. Review
  14. Review
  15. Review
  16. Review
  17. Article
  18. Article
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  20. Article

522 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 4 institutions in 1 country.

Claudio G BrunsteinBlood and Marrow Transplant Program, University of Minnesota, Minneapolis, MN, USA. bruns072@umn.edu
Jeffrey S Miller
Qing Cao
David H McKenna
Keli L Hippen
Julie Curtsinger
Todd Defor
Bruce L Levine
Carl H June
Pablo Rubinstein
Philip B McGlave
Bruce R Blazar
John E Wagner
University of Minnesota · USUniversity of Minnesota Medical Center · USUniversity of Pennsylvania · USNew York Blood Center · US

Funding

Trial Design and Biostatistical Support CoreP01CA065493 · NCI · UNIVERSITY OF MINNESOTA TWIN CITIES · PI Mark J Osborn · 1995 to 2026
$48.2M
Transgenic/KnockoutP01AI056299 · NIAID · HARVARD UNIVERSITY (MEDICAL SCHOOL) · PI BLAZAR, BRUCE R · 2003 to 2023
$42.5M
Project 3: Humoral Targets and B Cell Biology in Chronic Graft-vs.-Host DiseaseP01CA142106 · NCI · DANA-FARBER CANCER INST · PI RITZ, JEROME · 2009 to 2019
$17.5M
T-CELL TARGETING FOR GVHDR01HL056067 · NHLBI · UNIVERSITY OF MINNESOTA TWIN CITIES · PI BLAZAR, BRUCE R · 1995 to 2022
$5.4M
Culture systems to propogate human T cell subsetsR01CA105216 · NCI · UNIVERSITY OF PENNSYLVANIA · PI JUNE, CARL H. · 2004 to 2008
$1.5M
NCI NIH HHS P01 CA065493NCI NIH HHS P01 CA142106NCI NIH HHS P01 CA65493NCI NIH HHS R01 CA105216NHLBI NIH HHS HHSN268201000008CNHLBI NIH HHS N01 HB037164NHLBI NIH HHS R01 HL056067NIAID NIH HHS P01 AI056299
6 · The paper itself

Abstract

Acute graft-versus-host disease (aGVHD) is associated with high risk of morbidity and mortality and is a common complication after double umbilical cord blood (UCB) transplantation. To reduce these risks, we established a method of CD4(+)CD25(+)FoxP3(+) T regulatory cell (Treg) enrichment from cryopreserved UCB followed by a 18 (+) 1-day expansion culture including anti-CD3/anti-CD28 antibody-coated beads and recombinant human interleukin-2. In a "first-in-human" clinical trial, we evaluated the safety profile of UCB Treg in 23 patients. Patients received a dose of 0.1-30 × 10(5)UCB Treg/kg after double UCB transplantation. The targeted Treg dose was achieved in 74% of cultures, with all products being suppressive in vitro (median 86% suppression at a 1:4 ratio). No infusional toxicities were observed. After infusion, UCB Treg could be detected for 14 days, with the greatest proportion of circulating CD4(+)CD127(-)FoxP3(+) cells observed on day (+)2. Compared with identically treated 108 historical controls without Treg, there was a reduced incidence of grade II-IV aGVHD (43% vs 61%, P = .05) with no deleterious effect on risks of infection, relapse, or early mortality. These results set the stage for a definitive study of UCB Treg to determine its potency in preventing allogeneic aGVHD. This study is registered at http://www.clinicaltrials.gov as NCT00602693.

Indexed as

Cell ProliferationAdultAgedCells, CulturedCord Blood Stem Cell TransplantationFemaleFetal BloodGraft vs Host DiseaseHumansLeukemiaMaleMiddle AgedT-Lymphocytes, RegulatoryTransplantation, HomologousTreatment OutcomeYoung Adult

Identifiers

PMID20952687
PMCPMC3035067
OpenAlexW2073045132

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

and 1 more above

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 Socratic graph.