Multiple Donor Treg DLI for Severe Refractory Chronic GVHD

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

August 3, 2016

Primary Completion Date

December 31, 2021

Study Completion Date

June 30, 2022

Conditions
Chronic Graft Versus Host Disease
Interventions
BIOLOGICAL

T reg DLI

"Purified Treg cells will be obtained from the original HSC donor (T reg DLI).~Tregs preparation will start with unstimulated donor leukapheresis from the original stem cell donor.~The apheresis product will be provided to the Cell Factory Calori,Milano, where T reg purification will take place.~T reg cells will be PURIFIED utilizing the CliniMACS Plus Systems for depletion of CD8 and CD19 positive cells and enrichment for CD25high cells.~Release Criteria of Treg cell preparation will be defined.~The product will be infused into the recipient through a venous catheter."

Trial Locations (1)

40138

University Hospital St. Orsola-Malpighi Polyclinic, Bologna

All Listed Sponsors
collaborator

European Commission

OTHER

lead

Mario Arpinati

OTHER

NCT02749084 - Multiple Donor Treg DLI for Severe Refractory Chronic GVHD | Biotech Hunter | Biotech Hunter