Osteoarthritis
Conditions
Interventions
Experiment group 1:Intra-articular CEFFE injection (low dose)
Experiment group 2:Intra-articular CEFFE injection (medium dose)
Experiment group 3:Intra-articular CEFFE injection (High dose)
Sponsors
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
20 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 20~80 years (including the boundary value), male or female; 2. BMI is 18.5~30kg/m2 (including boundary value); 3. According to the diagnostic criteria for knee osteoarthritis in the Guidelines for the Diagnosis and Treatment of Osteoarthritis (2018 Edition), the knee has recurrent knee pain within the past 1 month and meets any two of the following criteria: (1) X-ray films (standing or weight-bearing) show narrowing of the joint space, subchondral bone sclerosis and (or) cystic degeneration, and the formation of osteophytes at the joint edge; (2) Aged >= 50 years; (3) Morning stiffness time <= 30 minutes; (4) Bone fricative (sense) during activity; 4. Kellgren & Lawrence classification of knee joint I~III; 5. At baseline, the Western Ontario and McMaster Universities (WOMAC) pain subscale score was 7-17 points (including boundary values) (5 items, 0-20 points) (accepted only WOMAC score at least 48 hours after discontinuation of all pain medications); 6. Subjects agree to discontinue all pain relievers for OA 7 days before the first treatment with the study drug (if the 5 half-life of the drug exceeds 7 days, the drug needs to be discontinued before the 5 half-life), except for acetaminophen ; 7. Subjects are usually active, not bedridden or wheelchair-bound, and can walk more than 50 meters without the help of crutches or canes; 8. The subjects have no plans to become pregnant during the trial and within 90 days of the last administration and voluntarily take effective contraceptive measures; 9. Voluntarily sign and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. According to the judgment of the investigator, the subject has a history of trauma, and the injury affects the target knee joint; 2. 6 months before screening, there is obvious trauma involving the target knee joint; 3. The subject has OA of the ipsilateral lower extremity joint other than the knee joint that needs to be treated, or has other inflammatory diseases affecting the joints (such as: rheumatoid arthritis, psoriatic arthritis, gouty arthritis, symptoms cartilage calcification, osteonecrosis, active infection), or peripheral or central neuropathies (eg, back pain, hip pain, herniated disc, sciatic nerve) that, at the investigator's discretion, may interfere with the assessment of pain and function of the target knee pain, fibromyalgia, diabetic neuropathy, etc.); 4. The target knee joint has obvious valgus/varus deformity (>15 degree varus and varus, and obvious flexion contracture deformity > 5 degree); 5. Plan to perform surgical treatment on any lower extremity joint other than the ipsilateral knee joint during the study period; 6. The target knee joint has infectious arthritis or past history; 7. During the screening period, the target knee has active joint infection or skin ulceration in the injection site area, infection, or the presence of any significant chronic skin disease that may interfere with intra-articular injection and/or injection site evaluation; 8. Subjects who have used opioids or glucocorticoids within 30 days before screening; or who need to use opioids or glucocorticoids for long-term treatment during the study; 9. Patients who have received any drug injection in the knee joint (bilateral or any side) within 6 months before the start of treatment; 10. Contralateral knee osteoarthritis, or any hip osteoarthritis symptoms, which cannot be relieved with acetaminophen/or need to accept any regimen to terminate the treatment; 11. Those who have used glucosamine, chondroitin sulfate, diacerein or avocado/soybean extract within 8 weeks before screening; 12. Subject has asthma requiring systemic glucocorticoid therapy. However, patients with asthma who only need inhaled corticosteroids can be included; 13. There are contraindications for MRI detection, including but not limited to: internal installation of cardiac pacemakers, defibrillators, cardiac stents, artificial heart valves, metal clips after aneurysm surgery, implanted drug infusion devices, implanted in vivo Any electronic devices (nerve stimulators, bone growth stimulators), endovascular embolization rings, filters, ECG recording monitors, metal sutures, those with shrapnel or iron grit in the body, post-fracture fixation steel plates and nails, artificial Cochlear, middle ear graft, intraocular metal foreign body, etc.; claustrophobia, critically ill patients, etc.; 14. Abnormal liver function and renal function: AST or ALT > 2 x upper limits of normal (ULN) at screening; or serum creatinine > 1.5 x ULN, or creatinine clearance <= 50 mL/min; Note: male creatinine clearance rate (mL/min) = [(140-age) x body weight (kg)]/[0.818 x Cr (umol/L)]; female creatinine clearance rate (mL/min) = male creatinine clearance rate (mL/min) x 0.85; 15. The subject is receiving systemic chemotherapy for any type of active malignancy; or has been diagnosed with cancer (but not squamous cell carcinoma or basal cell carcinoma of the skin) within 5 years prior to screening; 16. According to the judgment of the investigator, before enrollment, there are c
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety indexes; | — |
Secondary
| Measure | Time frame |
|---|---|
| knee pain;Stiffness;Function; | — |
Countries
China
Contacts
Public ContactYan Mengning
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed