Mesenchymal Stem Cells (MSCs) for Steroid Refractory Acute GVHD (SR-aGVHD)

Status Withdrawn

Clinical Trial Summary

The objective of this clinical study is to demonstrate safety and feasibility of single-dose infusion of Ossium MSCs product (OSSM-001) to treat steroid refractory acute GVHD (SR-aGVHD).

Clinical Trial Description

The dose escalation will be used to establish a maximum tolerated dose, starting from 2M cells/kg. If no safety issues are seen, then MSCs dose maybe escalated to 6M cells/kg, 12M cells/kg and 24M cell/kg based on data review from each cohort. Additional studies will be conducted to establish a dosing regimen and to evaluate the safety and efficacy of OSSM-001 for SR-aGVHD patients. ;

Study Design

Related Conditions & MeSH terms

GVHD,Acute

Clinical Trial Details

NCT number	NCT05443464
Study type	Interventional
Source	Ossium Health, Inc.
Contact
Status	Withdrawn
Phase	Phase 1
Start date	June 5, 2023
Completion date	October 14, 2024

View Details

See also
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