TerminatedPhase 2

Decidua Stroma Cells for Steroid Resistent Acute Graft-versus-host Disease After Allo-HSCT

Stopped: Too slow recruitment

Denmark, Norway, Sweden12 participantsStarted 2021-12-01

Plain-language 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 refractory acute graft vs. host disease in the second part of the study. Patients will receive 2 doses of DSC. Additional doses (up to 4 doses) may be given depending on response. No cross-over are planned in the second stage of the study.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Safety and tolerability evaluation including Severe Adverse Events (SAE).

Timeframe: 5 years

Durable Response to treatment

Timeframe: 56 days

Trial details

NCT IDNCT04118556

SponsorMats Remberger

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-29

View on ClinicalTrials.gov More GVHD, Acute trials