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RECRUITING
NCT04118556
PHASE2

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

Sponsor: Mats Remberger

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2021-12-01

Completion Date

2031-12-31

Last Updated

2024-12-12

Healthy Volunteers

No

Conditions

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.

Locations (6)

Copenhagen Univerity Hospital

Copenhagen, Denmark

Oslo University Hospital

Oslo, Norway

Gothenburg University Hospital

Gothenburg, Sweden

Lund University Hospital

Lund, Sweden

Karolinska University Hospital

Stockholm, Sweden

Uppsala University Hospital

Uppsala, Sweden