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

NCT04118556 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-05-06

No results posted yet for this study

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.

Conditions

  • GVHD, Acute

Interventions

BIOLOGICAL

Decidua Stroma Cells (DSC)

Placenta-derived Decidua Stroma Cells. The product consists of a viable allogeneic DSCs frozen in 5% of human serum albumin (HSA) in sodium chloride (NaCl) 0.9% and 10% dimethylsulfoxide (DMSO), that is thawed and immediately diluted in 40 mL sodium chloride (NaCl) 0.9% prior to infusion. That will give a final concentration of 2.2% HSA and 2% DMSO. DSC will be infused when steroid-refractory acute GVHD after allogenic stem-cell transplantation has been diagnosed. Two doses, one week apart, will be given to all patients. Additional doses will be used depending on response.

DRUG

Best available Treatment (BAT)

The BAT in this study will freely be identified by the Investigator prior to patient randomization and may include treatments such as: extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), etanercept, vedolizumab, ruxolitinib or infliximab. Dose and frequency will depend on label (where approved) and institutional guidelines for various BAT.

Sponsors & Collaborators

  • The Swedish Research Council

    collaborator OTHER_GOV

  • Mats Remberger

    lead OTHER

Principal Investigators

  • Mats Remberger, Professor · KFUE, Uppsala University Hospital, Uppsala, Sweden

  • Ulla Olsson-Strömberg, AssProfessor · Dep of Hematology, Uppsala University Hospital, Uppsala, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2026-04-29
Completion
2026-04-29

Countries

  • Denmark
  • Norway
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04118556 on ClinicalTrials.gov