This clinical study is to investigate the safety and efficacy of NCR100 injection in subjects with knee osteoarthritis (KOA). It contains two parts dose-escalating, and blind random study in adult KOA subjects.
Knee osteoarthritis(KOA) is a kind of degenerative joint disease characterized by chronic inflammation loss of articular cartilage and subchondral bone remodeling.In China, the estimated number of patients diagnosed with KOA reached 37.35millon. The aim of this sudy 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
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
162
Subjects will receive multiple intra-articular NCR100 injections.
Subjects will receive multiple intra-articular 0.9% Normal saline injections.
Dose-Limiting Toxicity(DLT)
Number of participants with Dose-limiting toxicity in 28 days
Time frame: 4 weeks after first injection
The Western Ontario and McMaster Universities osteoarthritis index(WOMAC)
Differences of WOMAC scores in changes from baseline between the experimental group and the control group
Time frame: 48 weeks after first injection
Adverse Event(AE) or Serious Adverse Event(SAE)
Number of participants with treatment-related adverse events or serious adverse events assessed by CTCAE v5.0
Time frame: Within 48 weeks of the first infusion
Visual analogue scale (VAS)
Differences in changes from baseline between experimental groups and the control group.
Time frame: 8 weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks
Differences in changes from baseline at 8 weeks, 12 weeks, 24 weeks and 36 weeks of the Western Ontario and McMaster Universities Arthritis Index (WOMAC) between the experimental groups and the control group
WOMAC scores include three subscale scores (pain, stiffness, and physical function)
Time frame: 8 weeks, 12 weeks, 24 weeks and 36 weeks
Differences in changes from baseline to 24 weeks and 48 weeks in cartilages with various regions
Magnetic resonance imaging (MRI) is used to scan images of knees.
Time frame: 24 weeks and 48 weeks
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