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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
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.
26 April 2026
Quick facts
| Lead sponsor | University Health Network, Toronto |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 22 December 2021 |
| Primary completion | 26 April 2026 |
| Estimated completion | 26 April 2026 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Drug or biologic - anti-thymocyte globulin (ATG), extracorporeal photopheresis (ECP), mTOR inhibitors (everolimus or sirolimus), vedolizumab, ruxolitinib.
- Decidual Stromal Cells — full drug profile →
Conditions studied
- Graft Vs Host Disease — all drugs for Graft Vs Host Disease →
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):
-
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
Verify or expand the search:
- PubMed search for NCT05132166
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Graft Vs Host Disease
Currently open trials in the same condition.
- NCT07006506 — A Study of Belumosudil in People at Risk of Developing Graft-Versus-Host Disease After a Stem Cell Transplant · Phase 2 · recruiting
- NCT06008808 — Ruxolitinib With and Without CTLA-4 Ig Abatacept for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release S · Phase 1 · recruiting
- NCT07365696 — Fatigue and Cognitive Dysfunction Due to Synaptopathy or Graft Versus Host (GVH) Disease in the Brain. · recruiting
- NCT05621759 — Cyclophosphamide, Abatacept, and Tacrolimus for the Prevention of GvHD · Phase 2 · active not recruiting
- NCT05236062 — Impact of Exercise on the Complications of Corticosteroids in Patients With GVHD: the RESTART Trial · NA · recruiting
Other University Health Network, Toronto trials
Trials by the same sponsor.
- NCT06831032 — Elective Adaptive Radiation With SBRT for Improved DurabilitY of Response · NA · recruiting
- NCT06634056 — Pneumonitis Prevention Protocol Using Pentoxifylline and α-tocopherol In Stage III Non-Small Cell Lung Cancer Patients U · Phase 2 · not yet recruiting
- NCT06836726 — Clinical Trial to Test Efficacy of Targeting Hypoxia Combined With ARSI After First-line ARSI Therapy for Castrate Resis · Phase 2 · not yet recruiting
- NCT07515651 — Molecular Imaging Informed Radiation Dose Escalation to Sites of Recurrent Disease and De-escalation to Uninvolved Areas · Phase 2 · not yet recruiting
- NCT07509450 — Fecal Microbiota Transplantation in Patients Undergoing Chimeric Antigen Receptor T-cell Therapy and Allogeneic Stem Cel · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05132166 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Health Network, Toronto
- Last refreshed: 22 June 2025
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