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NCT05132166

A Randomized Phase II Study to Compare the Potential Long-Lasting Positive Effect of Decidual Stromal Cells to the Best Available Treatment in Graft Versus Host Disease

Active, enrolled Phase 2 Last updated 22 June 2025
What this trial tests

Phase 2 trial testing Drug or biologic - anti-thymocyte globulin (ATG), extracorporeal photopheresis (ECP), mTOR inhibitors (everolimus or sirolimus), vedolizumab, ruxolitinib. in Graft Vs Host Disease in 50 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
22 December 2021
Primary endpoint
26 April 2026
26 April 2026

Quick facts

Lead sponsorUniversity Health Network, Toronto
PhasePhase 2
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment50
Start date22 December 2021
Primary completion26 April 2026
Estimated completion26 April 2026
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

University Health Network, Toronto

Who can join

18 and older, any sex, with Graft Vs Host Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an academic open-label, phase II randomized study in patients with steroid resistant severe acute Graft versus host disease (GvHD) who have had allogeneic hematopoietic stem cell transplantation. The main purpose of this study is to compare the efficacy of Decidual Stromal Cells (DSC) with Investigators choice best available treatment (BAT). If randomized to DSC arm, patients will receive 2 infusions in the vein at least one week apart. Additional doses (up to 4 doses) of DSC may be given depending on response.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. T cell trafficking in human chronic inflammatory diseases.
    Giovenzana A, Codazzi V, Pandolfo M, Petrelli A. · · 2024 · cited 5× · PMID 39171290 · DOI 10.1016/j.isci.2024.110528

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Other recruiting trials for Graft Vs Host Disease

Currently open trials in the same condition.

Other University Health Network, Toronto trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05132166.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing