A Randomized Phase II Study to Compare the Potential Long-Lasting Positive Effect of Decidual Stromal Cells to the Best Available Treatment in Graft Versus Host Disease

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

December 22, 2021

Primary Completion Date

April 26, 2026

Study Completion Date

April 26, 2026

Conditions
Graft Vs Host Disease
Interventions
OTHER

Drug or biologic - anti-thymocyte globulin (ATG), extracorporeal photopheresis (ECP), mTOR inhibitors (everolimus or sirolimus), vedolizumab, ruxolitinib.

Will vary depending upon Investigator's choice identified prior to randomization. Dose and frequency will depend on label (where approved) and institutional guidelines for various BAT. No cross-over to DSC treatment is planned. The BAT in this study will freely be identified by the Investigator prior to patient randomization and may include treatments such as: anti-thymocyte globulin (ATG), extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mTOR inhibitors (everolimus or sirolimus), vedolizumab, ruxolitinib.

BIOLOGICAL

Decidual Stromal Cells

The dose will be 1×106 DSC/kg bodyweight, at least 2 doses at least one week apart. Within the first 28 days, patients meeting criteria of aGvHD disease progression, mixed response or no response, may be given additional weekly doses of DSC until satisfactory response (ie: CR) are reached (max 4 doses in total).

Trial Locations (1)

Unknown

Princess Margaret Cancer Centre, Toronto

All Listed Sponsors
lead

University Health Network, Toronto

OTHER