drugset / Trial / NCT03298399

Mesenchymal Stromal Cells for Haplo Hematopoietic Cell Transplantation for Sickle Cell Disease

NCT03298399

Non-randomizedSequentialOpen-labelTreatment

Summary

This trial is being conducted as a step toward testing the long-term hypothesis that freshly cultured, autologous mesenchymal stromal cells (MSCs) grown in platelet lysate-containing medium will modulate recipient T-cell immune responses and promote engraftment in haploidentical hematopoietic cell transplant (HCT) recipients. As a phase I, dose escalation trial of autologous MSCs in patients with sickle cell disease (SCD) undergoing haploidentical HCT, the main aim is to evaluate the safety of this therapy with a secondary aim to evaluate its effects on engraftment and graft-versus-host disease (GVHD).

Timeline

Start
2017-12-21
Primary completion
2018-10-25
Completion
2018-10-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Autologous MSCs Cell therapy 2e+06 cells/kg Intravenous

Indications