A Trial to Evaluate the Safety, Tolerability, and Efficacy of NCR100 Injection in the Treatment of Subjects With KOA (NCR100)

Inclusion Criteria: Subjects who understand and voluntarily sign the Informed Consent Form（ICF） before the enrolment; Age: 40-80 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, or aggravation or recurrence of osteoarthritis after routine medication; Kellgren-Lawrence grade: II-III; McMaster Universities Osteoarthritis Index (WOMAC): 24-72. Exclusion Criteria: Subjects previously diagnosed of secondary knee osteoarthritis, or those diagnosed with hip/ankle joint disease requiring medical intervention; Subjects who suffering from other diseases that cause damage to knee joint function or affect joints; Subjects who have received allogeneic mesenchymal progenitor (stem/stromal) cell therapy; Subjects who have history of knee joint injury; Subjects who have undergone knee arthroscopic surgery; Subjects who received painkillers ( eg,opioids/nonsteroidal anti-inflammatory analgesics ) to treat knee osteoarthritis; Subjects who have orally taken traditional Chinese medicine; Subjects who have received intra-articular drug injection to treat knee osteoarthritis; Subjects with glucosamine, chondroitin sulfate, or diacetate therapy before investigational drug intervention Subjects with acute reactive knee osteoarthritis; Severe eversion deformity in target knee joint; Known or suspected allergy or a history of allergies; Subjects with abnormal results of laboratory examination: Hepatic Insufficiency (ALT > 2xULN or Aspartate aminotransferase（AST） > 2xULN), renal dysfunction (creatinine clearance rate ≤60ml/min or blood urea nitrogen(BUN) > 2× ULN), Coagulation Defects (INR > 1.5) or severe hematological diseases (Grade 3 or above anemia Hb < 8 g/dL, Grade 2 or above thrombocytopenia platelet count(PLT) < 75×10^9/L) ; BMI≥30 kg/m^2 ; Severe systemic infection or local knee joint infection; Subjects who have received systemic glucocorticoid therapy before intervention or need to take systemic glucocorticoid therapy during the treatment; Subjects who have history of acute myocardial infarction or with heart diseases e.g.uncontrolled angina pectoris, uncontrolled arrhythmias, severe heart failure (NYHA > III), QT prolongation, and are determined by investigators as not suitable to participate in this clinical trial; Subjects with peripheral or central nervous system disorders that may interfere with knee joint pain and functional assessment, Subjects who have contraindications to MRI; Subjects who have poor physical condition and are unable to walk autonomously; Subjects with alcohol or drug addiction or with a clear history of mental disorders or with a history of drug abuse or drug use of psychotropic substances; Subjects with infection with hepatitis B virus(HBV), hepatitis C virus(HCV), HIV, and treponema pallidum confirmed by laboratory tests; Pregnant or lactating female subjects, or subjects who are unable to comply with contraceptives from the study period to 6 months after the end of this study; Subjects who have participated in other clinical trials and have used other study products; Subjects with severe and poorly controlled comorbidities and not suitable for this clinical trial; Subjects who are not suitable for this clinical trial for other reasons.