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.
Subjects who understand and voluntarily sign the Informed Consent Form（ICF） before the enrolment;
Age: 40-65 years old, both genders;
Diagnosis of knee osteoarthritis based on American College of Rheumatology criteria;
Subjects with KOA who have persistent pain for more than six months
Subjects previously diagnosed of secondary knee osteoarthritis, or those diagnosed with hip/ankle joint disease requiring medical intervention;
Suffering from other diseases that impair knee function or joints;
Have received stem cell therapy;
Have knee injury history;
Parallel
NCR100
Biological/VaccineSubjects will receive multiple intra-articular NCR100 injections.
0.9% Normal saline
Other interventionSubjects will receive multiple intra-articular 0.9% Normal saline injections.
Dose-Limiting Toxicity(DLT)
Number of participants with Dose-limiting toxicity in 28 days
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
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
Visual analogue scale (VAS)
Differences in changes from baseline between experimental groups and the control group.
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)
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.
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Nuwacell Biotechnologies Co., Ltd.
Lead sponsor
Shanghai 6th People's Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
