Status:
RECRUITING
Decidua Stroma Cells for Steroid Resistent Acute Graft-versus-host Disease After Allo-HSCT
Lead Sponsor:
Mats Remberger
Collaborating Sponsors:
The Swedish Research Council
Conditions:
GVHD, Acute
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A randomized (1:1) phase II open label study of DSC compared to Investigator choice Best Available Therapy (BAT) in allogeneic hematopoietic stem cell transplant recipients with Grades II-IV steroid r...
Detailed Description
Main inclusion criteria: Adult patients (age ≥ 18 years) with steroid refractory (SR) acute GvHD (aGVHD) grades II-IV after allo-HSCT. Signed written study informed consent once SR-aGvHD is confirme...
Eligibility Criteria
Inclusion
- Adult patients (age ≥ 18 years) with steroid refractory acute GvHD grades II-IV after allo-HSCT.
- Signed written study informed consent once SR-aGvHD is confirmed.
Exclusion
- Presence of an active uncontrolled infection including significant bacterial, fungal, viral or parasitic infection requiring treatment.
- Has received systemic treatment for aGvHD apart from steroids.
- Clinical presentation resembling de novo chronic GvHD or GvHD overlap syndrome.
- Pregnant or lactating women.
- Significant respiratory disease.
- Presence of severely impaired renal function
- Any corticosteroid therapy for indications other than aGvHD
- Previous participation in a study of any investigational treatment agent within 30 days
- Known human immunodeficiency virus infection (HIV).
- Patients suffering on active tuberculosis or viral hepatitis
- Significant respiratory disease
- Presence of severely impaired renal or liver function
- History of progressive multifocal leuko-encephalopathy
- Patients with coagulopathy
- History of severe chronic history of heart disease
- Any condition that would, in the Investigator's judgment, interfere with full participation in the study.
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2031
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04118556
Start Date
December 1 2021
End Date
December 31 2031
Last Update
December 12 2024
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Copenhagen Univerity Hospital
Copenhagen, Denmark, 2300
2
Oslo University Hospital
Oslo, Norway, NO-0424
3
Gothenburg University Hospital
Gothenburg, Sweden, SE-413 45
4
Lund University Hospital
Lund, Sweden, SE-221 85