Evidence map›Paper›PMID 25836589›Full record

Trial reportLeukemia2015

Biomarker profiling of steroid-resistant acute GVHD in patients after infusion of mesenchymal stromal cells.

L C J Te Boome, C Mansilla, L E van der Wagen, C A Lindemans, E J Petersen, E Spierings, K A Thus, K Westinga, M Plantinga, M Bierings and 11 more

Abstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Leukemia, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 3 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

39 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. The Role of Biomarkers in the Diagnosis and Risk Stratification of Acute Graft-versus-Host Disease: A Systematic Review.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2016
    Pooled it
  4. Trial
  5. Review
  6. Observational
  7. Review
  8. Article
  9. Review
  10. Review
  11. Review
  12. Review
  13. Review
  14. Article
  15. Translating MSC Therapy in the Age of Obesity.Frontiers in immunology · 2022
    Review
  16. Article
  17. Article
  18. Prevention and Treatment of Acute Graft-versus-Host Disease in Children, Adolescents, and Young Adults.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2020
    Review
  19. Article
  20. Adipose tissue-derived stem cells modulate immune functionExperimental and therapeutic medicine · 2020
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors.

L C J Te BoomeDepartment of Haematology, University Medical Center Utrecht, Utrecht, The Netherlands.
C MansillaUMC Utrecht, Laboratory of Translational Immunology, University Medical Center Utrecht, Utrecht, The Netherlands.
L E van der WagenDepartment of Haematology, University Medical Center Utrecht, Utrecht, The Netherlands.
C A LindemansUMC Utrecht, Laboratory of Translational Immunology, University Medical Center Utrecht, Utrecht, The Netherlands.
E J PetersenDepartment of Haematology, University Medical Center Utrecht, Utrecht, The Netherlands.
E SpieringsUMC Utrecht, Laboratory of Translational Immunology, University Medical Center Utrecht, Utrecht, The Netherlands.ORCID http://orcid.org/0000-0001-9441-1019
K A ThusUMC Utrecht, Laboratory of Translational Immunology, University Medical Center Utrecht, Utrecht, The Netherlands.
K WestingaDepartment of Clinical Pharmacy - Cell Therapy Facility, UMC Utrecht, University Medical Center Utrecht, Utrecht, The Netherlands.
M PlantingaUMC Utrecht, Laboratory of Translational Immunology, University Medical Center Utrecht, Utrecht, The Netherlands.
M BieringsUMC Utrecht, Paediatrics - Blood and Marrow Transplantation Program, University Medical Center Utrecht, Utrecht, The Netherlands.
A E C BroersDepartment of Haematology, Erasmus MC Rotterdam, Rotterdam, The Netherlands.
M L H CuijpersDepartment of Haematology, University Medical Center Utrecht, Utrecht, The Netherlands.
G W van ImhoffDepartment of Haematology, UMC Groningen, Groningen, The Netherlands.
J J JanssenDepartment of Haematology, VU MC, Amsterdam, The Netherlands.
C HuismanDepartment of Haematology, AMC, Amsterdam, The Netherlands.
S ZeerlederDepartment of Haematology, AMC, Amsterdam, The Netherlands.
G HulsDepartment of Haematology, Radboud UMC Nijmegen, Amsterdam, The Netherlands.
J J BoelensUMC Utrecht, Laboratory of Translational Immunology, University Medical Center Utrecht, Utrecht, The Netherlands.
N M WulffraatUMC Utrecht, Laboratory of Translational Immunology, University Medical Center Utrecht, Utrecht, The Netherlands.
I C M Slaper-CortenbachDepartment of Clinical Pharmacy - Cell Therapy Facility, UMC Utrecht, University Medical Center Utrecht, Utrecht, The Netherlands.
J KuballDepartment of Haematology, University Medical Center Utrecht, Utrecht, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We performed a prospective phase II study to evaluate clinical safety and outcome in 48 patients with steroid-refractory grade II-IV acute graft-versus-host disease (aGVHD) treated with mesenchymal stromal cells (MSCs). Clinical outcomes were correlated to comprehensive analyses of soluble and cellular biomarkers. Complete resolution (CR) of aGVHD at day 28 (CR-28) occurred in 12 (25%) patients, CR lasting >1 month (CR-B) occurred in 24 (50%) patients. One-year overall survival was significantly improved in CR-28 (75 versus 33%, P=0.020) and CR-B (79 versus 8%, P<0.001) versus non-CR patients. A six soluble biomarker-panel was predictive for mortality (HR 2.924; CI 1.485-5.758) when measured before MSC-administration. Suppression of tumorigenicity 2 (ST2) was only predictive for mortality 2 weeks after but not before MSC-administration (HR 2.389; CI 1.144-4.989). In addition, an increase in immature myeloid dendritic cells associated with decreased mortality (HR 0.554, CI 0.389-0.790). Patients had persisting T-cell responses against defined virus- and leukemia-associated antigens. In conclusion, our data emphasize the need to carefully assess biomarkers in cohorts with homogeneous GVHD treatments. Biomarkers might become an additional valuable component of composite end points for the rapid and efficient testing of novel compounds to decrease lifecycle of clinical testing and improve the success rate of phase II/III trials.

Indexed as

Drug ResistanceMesenchymal Stem Cell TransplantationAcute DiseaseAdolescentAdultAgedAntigens, NeoplasmBiomarkersChildChild, PreschoolCyclosporineCytokinesFemaleGraft vs Host DiseaseHumansImmunophenotypingAntigens, NeoplasmBiomarkersCyclosporineCytokinesImmunosuppressive AgentsPrednisoneSteroids

Identifiers

PMID25836589

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.