drugset / Trial / NCT04328714

Interferon γ-Primed Mesenchymal Stromal Cells as Prophylaxis for Acute Graft v Host Disease

NCT04328714

Phase 1 Terminated 4 enrolled Edwin Horwitz Ossium Health, Inc. · collab
Non-randomizedSequentialOpen-labelTreatment

Summary

The protocol is a phase I open label study evaluating the safety and feasibility of peri-transplant infusion of freshly expanded interferon gamma primed MSCs in adult and pediatric patients undergoing HCT for acute leukemia and myelodysplastic syndrome (MDS).

Timeline

Start
2021-12-02
Primary completion
2022-07-20
Completion
2022-07-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Interferon gamma (IFNγ)-primed human bone marrow-derived mesenchymal stromal cells Cell therapy 2e+06 cells/kg Intravenous
Subject Interferon gamma (IFNγ)-primed human bone marrow-derived mesenchymal stromal cells Cell therapy 5e+06 cells/kg Intravenous
Subject Interferon gamma (IFNγ)-primed human bone marrow-derived mesenchymal stromal cells Cell therapy 1e+07 cells/kg Intravenous