A study to evaluate the safety and preliminary efficacy of iMSC in subjects with SR-aGVHD
A single center, open label, dose escalation study to evaluate the safety,tolerability and preliminary efficacy of iMSC in subjects with SR-aGVHD
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Subjects will receive 4 or more times of iMSC injection
Anhui Provincial Hospital
Hefei, Anhui, China
RECRUITINGDose-Limiting Toxicity(DLT)
Number of Dose-limiting toxicity in 28 days after injection
Time frame: 4 weeks after initial infusion
Adverse Event(AE),Serious Adverse Event(SAE),Treatment Emergent Adverse Event(TEAE)and Treatment Related Adverse Event(TRAE)
Number of treatment-related adverse events,treatment emergent adverse event,treatment related adverse event or serious adverse events as assessed by CTCAE v5.0
Time frame: From the date of initial infusion to 180 days after initial infusion
Objective Response Rate(ORR)
Percentage of participants achieved Complete Response(CR) or Partial Response(PR)
Time frame: 28 days after initial infusion
Overall Survival(OS)
The time from initial infusion to death
Time frame: 100 days after initial infusion
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