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).
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Direct IV infusion of OSSM-001
Safety events
OSSM-001 related safety events
Time frame: 112 days (16 weeks)
Maximum tolerated dose (MTD)
Determine MTD of OSSM-001
Time frame: 112 days (16 weeks)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.