Using Decidua Stroma Cells to treat steroid-resistant acute graft-versus-host disease
A Multicenter, Open-label, Randomized, Phase I/II Clinical Trial Comparing Safety and Durable Overall Response Day 56 in Patients With Steroid Resistent Acute GvHD After Allogeneic Hematopoietic Stem Cell Transplant Treated With DSC or BAT
This study is testing if Decidua Stroma Cells can help adults with steroid-resistant acute graft-versus-host disease feel better compared to the best current treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Uppsala University Hospital Academic / other |
| Locations | 6 sites (Copenhagen and 5 other locations) |
| Trial ID | NCT04118556 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial investigates the efficacy and safety of Decidua Stroma Cells (DSC) compared to the Best Available Therapy (BAT) in adult patients with steroid-resistant acute graft-versus-host disease (aGvHD) grades II-IV following allogeneic hematopoietic stem cell transplantation (allo-HSCT). Participants will be randomly assigned to receive either DSC or BAT, with the primary objective being to assess the durable overall response at 56 days post-randomization. The study aims to enroll 50 patients, with a focus on determining the optimal dosing of DSC based on previous findings. The trial is designed to provide insights into a potentially novel treatment approach for aGvHD.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with steroid-resistant acute graft-versus-host disease grades II-IV after allo-HSCT.
Not a fit: Patients with active uncontrolled infections, significant respiratory disease, or those who have received systemic treatment for aGvHD apart from steroids may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients suffering from steroid-resistant acute graft-versus-host disease.
How similar studies have performed: While the use of Decidua Stroma Cells is a novel approach, similar studies have shown promise in treating graft-versus-host disease with alternative therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult patients (age ≥ 18 years) with steroid refractory acute GvHD grades II-IV after allo-HSCT. 2. Signed written study informed consent once SR-aGvHD is confirmed. Exclusion Criteria: 1. Presence of an active uncontrolled infection including significant bacterial, fungal, viral or parasitic infection requiring treatment. 2. Has received systemic treatment for aGvHD apart from steroids. 3. Clinical presentation resembling de novo chronic GvHD or GvHD overlap syndrome. 4. Pregnant or lactating women. 5. Significant respiratory disease. 6. Presence of severely impaired renal function 7. Any corticosteroid therapy for indications other than aGvHD 8. Previous participation in a study of any investigational treatment agent within 30 days 9. Known human immunodeficiency virus infection (HIV). 10. Patients suffering on active tuberculosis or viral hepatitis 11. Significant respiratory disease 12. Presence of severely impaired renal or liver function 13. History of progressive multifocal leuko-encephalopathy 14. Patients with coagulopathy 15. History of severe chronic history of heart disease 16. Any condition that would, in the Investigator's judgment, interfere with full participation in the study.
Where this trial is running
Copenhagen and 5 other locations
- Copenhagen Univerity Hospital — Copenhagen, Denmark (Recruiting)
- Oslo University Hospital — Oslo, Norway (Recruiting)
- Gothenburg University Hospital — Göteborg, Sweden (Withdrawn)
- Lund University Hospital — Lund, Sweden (Recruiting)
- Karolinska University Hospital — Stockholm, Sweden (Withdrawn)
- Uppsala University Hospital — Uppsala, Sweden (Recruiting)
Study contacts
- Principal investigator: Ulla Olsson-Strömberg, AssProfessor — Dep of Hematology, Uppsala University Hospital, Uppsala, Sweden
- Study coordinator: Mats Remberger, Professor
- Email: mats.remberger@akademiska.se
- Phone: +46-760165080
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.