Evidence map›Paper›PMID 26563133›Full record

Trial reportBlood2016

Umbilical cord blood-derived T regulatory cells to prevent GVHD: kinetics, toxicity profile, and clinical effect.

Claudio G Brunstein, Jeffrey S Miller, David H McKenna, Keli L Hippen, Todd E DeFor, Darin Sumstad, Julie Curtsinger, Michael R Verneris, Margaret L MacMillan, Bruce L Levine and 7 more

4 registry-linked trialsOpen access · bronzeAbstract readClinical Trial
In one paragraph

Trial report in Blood, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 271 papers.

0numbers the graph read from it
0cells of the map it votes in
271citing papers in PubMed
15.8field-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.

NCT05241444 phase1recruitingnot on this mapstarted 2022, after this paper: background citation

Phase 1 Study of Autologous CD4^LVFOXP3 in Participants With Immune Dysregulation Polyendocrinopathy Enteropathy X-linked (IPEX) Syndrome

TypeinterventionalSponsorBacchetta, Rosa, MDRan2022 to 2037Enrolled30ConditionsIPEXArmsCD4^LVFOXP3
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

271 citing papers in PubMed, 393 citations in OpenAlex.

  1. Trial
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  5. Article
  6. Regulatory T cells: From Foxp3 to tolerance-inducing therapies.The Journal of investigative dermatology · 2026
    Review
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  12. Decoding TNF receptor superfamily control of CD4Cell communication and signaling : CCS · 2026
    Review
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211 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 3 institutions in 2 countries.

Claudio G BrunsteinUniversity of Minnesota Blood and Marrow Transplant Program, Division of Hematology, Oncology and Transplantation.
Jeffrey S MillerUniversity of Minnesota Blood and Marrow Transplant Program, Division of Hematology, Oncology and Transplantation.
David H McKennaDepartment of Laboratory Medicine and Pathology, Molecular and Cellular Therapeutics Facility.
Keli L HippenUniversity of Minnesota Blood and Marrow Transplant Program, Division of Pediatric Blood and Marrow Transplantation, and.
Todd E DeForUniversity of Minnesota Blood and Marrow Transplant Program, Masonic Cancer Center, University of Minnesota, Minneapolis, MN;
Darin SumstadUniversity of Minnesota Blood and Marrow Transplant Program, Molecular and Cellular Therapeutics Facility.
Julie CurtsingerUniversity of Minnesota Blood and Marrow Transplant Program, Division of Pediatric Blood and Marrow Transplantation, and.
Michael R VernerisUniversity of Minnesota Blood and Marrow Transplant Program, Division of Pediatric Blood and Marrow Transplantation, and.
Margaret L MacMillanUniversity of Minnesota Blood and Marrow Transplant Program, Division of Pediatric Blood and Marrow Transplantation, and.
Bruce L LevineDepartment of Pathology and Laboratory Medicine and Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA; and.
James L RileyDepartment of Pathology and Laboratory Medicine and Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA; and.
Carl H JuneDepartment of Pathology and Laboratory Medicine and Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA; and.
Chap LeMasonic Cancer Center, University of Minnesota, Minneapolis, MN; Division of Biostatistics, University of Minnesota, Minneapolis, MN.
Daniel J WeisdorfUniversity of Minnesota Blood and Marrow Transplant Program, Division of Hematology, Oncology and Transplantation.
Philip B McGlaveUniversity of Minnesota Blood and Marrow Transplant Program, Division of Hematology, Oncology and Transplantation.
Bruce R BlazarUniversity of Minnesota Blood and Marrow Transplant Program, Division of Pediatric Blood and Marrow Transplantation, and.
John E WagnerUniversity of Minnesota Blood and Marrow Transplant Program, Division of Pediatric Blood and Marrow Transplantation, and.
University of Minnesota · USNHS Blood and Transplant · GBUniversity of Pennsylvania · US

Funding

UNIVERSITY OF PENNSYLVANIA CAN CTR SUPPORT GRANTP30CA016520 · NCI · UNIVERSITY OF PENNSYLVANIA · PI Robert H. Vonderheide · 1985 to 2026
$222.3M
Women's CancerP30CA077598 · NCI · UNIVERSITY OF MINNESOTA TWIN CITIES · PI Jeffrey S. Miller · 1998 to 2026
$100.4M
Trial Design and Biostatistical Support CoreP01CA065493 · NCI · UNIVERSITY OF MINNESOTA TWIN CITIES · PI J SUNIL RAO · 1995 to 2026
$48.2M
University of Minnesota Clinical and Translational Science Institute (UMN CTSI)UL1TR002494 · NCATS · UNIVERSITY OF MINNESOTA · PI BLAZAR, BRUCE R, WEISDORF, DANIEL J · 2018 to 2022
$34.9M
Enhancing Treg Therapeutic Efficacy in GVHDR01HL118979 · NHLBI · UNIVERSITY OF MINNESOTA · PI BLAZAR, BRUCE R, HIPPEN, KELI L · 2014 to 2025
$6.7M
IN VIVO PREVENTION OF MURINE GVHDR01AI034495 · NIAID · UNIVERSITY OF MINNESOTA TWIN CITIES · PI BLAZAR, BRUCE R · 1993 to 2016
$6.2M
T-CELL TARGETING FOR GVHDR01HL056067 · NHLBI · UNIVERSITY OF MINNESOTA TWIN CITIES · PI BLAZAR, BRUCE R · 1995 to 2022
$5.4M
GVL TO REDUCE AML RELAPSE AFTER MURINE ALLOGENEIC BMTR01CA072669 · NCI · UNIVERSITY OF MINNESOTA TWIN CITIES · PI BLAZAR, BRUCE R · 1997 to 2017
$4.9M
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 CA65493NCI NIH HHS P30 CA077598NCI NIH HHS P30 CA77598NCI NIH HHS R01 CA105216NHLBI NIH HHS HHSN268201000008CNHLBI NIH HHS R01 HL11879
6 · The paper itself

Abstract

We studied the safety and clinical outcomes of patients treated with umbilical cord blood (UCB)-derived regulatory T cells (Tregs) that expanded in cultures stimulated with K562 cells modified to express the high-affinity Fc receptor (CD64) and CD86, the natural ligand of CD28 (KT64/86). Eleven patients were treated with Treg doses from 3-100 × 10(6) Treg/kg. The median proportion of CD4(+)FoxP3(+)CD127(-) in the infused product was 87% (range, 78%-95%), and we observed no dose-limiting infusional adverse events. Clinical outcomes were compared with contemporary controls (n = 22) who received the same conditioning regimen with sirolimus and mycophenolate mofetil immune suppression. The incidence of grade II-IV acute graft-versus-host disease (GVHD) at 100 days was 9% (95% confidence interval [CI], 0-25) vs 45% (95% CI, 24-67) in controls (P = .05). Chronic GVHD at 1 year was zero in Tregs and 14% in controls. Hematopoietic recovery and chimerism, cumulative density of infections, nonrelapse mortality, relapse, and disease-free survival were similar in the Treg recipients and controls. KT64/86-expanded UCB Tregs were safe and resulted in low risk of acute GVHD.

Indexed as

AdolescentAdultAgedChildCord Blood Stem Cell TransplantationDisease-Free SurvivalFemaleFetal BloodGraft vs Host DiseaseHumansImmunotherapyIncidenceKaplan-Meier EstimateKineticsMaleMaximum Tolerated Dose

Identifiers

PMID26563133
PMCPMC4768428
OpenAlexW2337931770

What OpenQuestion holds

Textmetadata
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.