This clinical study is to investigate the safety and efficacy of NCR100 injection in subjects with knee osteoarthritis (KOA). It is a dose-escalating, open label study in adult KOA subjects.
Knee osteoarthritis (KOA) is a kind of degenerative joint disease and there are over 300 million cases worldwide. The aim of this clinical trial is to evaluate the safety, tolerability, and efficacy of human pluripotent stem cell derived mesenchymal stromal cells (NCR100) injection in the treatment of subjects with knee osteoarthritis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Subjects will receive a one-dose intra-articular NCR100 injection.
Adverse Event(AE) or Serious Adverse Event(SAE)
Number of participants with treatment-related adverse events or serious adverse events as assessed by CTCAE v5.0
Time frame: Week1,Week2,Week4
Dose-Limiting Toxicity(DLT)
Number of participants with Dose-limiting toxicity in 28 days after injection
Time frame: 4 weeks after injection
Maximum plasma concentration(Cmax)
Time frame: 30minutes before administration,24hours,1week,2week,4week,8week,12week and 24week after administration
Elimination half life of drug(T1/2)
Time frame: 30minutes before administration,24hours,1week,2week,4week,8week,12week and 24week after administration
Time after doing at which maximun plasma concentration is reached(Tmax)
Time frame: 30minutes before administration,24hours,1week,2week,4week,8week,12week and 24week after administration
Area under the plasma concentration-time curve(AUC)
Time frame: 30minutes before administration,24hours,1week,2week,4week,8week,12week and 24week after administration
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