Osteoarthritis
Conditions
Interventions
Experiment group:Intra-articular CEFFE injection
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. Age: 20 to 80 years (inclusive), male or female; 2. BMI: 18.5 to 30 kg/m² (inclusive); 3. According to the diagnostic criteria for knee osteoarthritis in the Clinical Practice Guidelines for Osteoarthritis (2018 edition), the subject has experienced recurrent knee joint pain within the past month and meets at least one of the following criteria: (1) X-ray (standing or weight-bearing position) shows joint space narrowing, subchondral bone sclerosis and/or cystic changes, and marginal osteophyte formation; (2) Age >= 50 years old; (3) Morning stiffness duration = 2 points (only scores assessed at least 48 hours after discontinuation of all analgesics are accepted); 6. The patient agrees to discontinue all OA-related pain-relieving medications at least 7 days prior to the first administration of the study drug (if the drug’s half-life exceeds 7 days, it should be discontinued for at least 5 half-lives), excluding acetaminophen; 7. The patient is generally ambulatory, not bedridden or wheelchair-bound long-term, and able to walk more than 50 meters without assistance from crutches or a cane; 8. During the study and for at least 90 days after the last administration, the subject has no plans for pregnancy and agrees to use effective contraception voluntarily; 9. Voluntarily signs and provides written informed consent.
Exclusion criteria
Exclusion criteria: 1. Significant trauma involving the target knee joint within 6 months prior to screening; 2. Presence of OA in other joints of the ipsilateral lower limb requiring treatment, or other inflammatory joint diseases affecting the joints (e.g., rheumatoid arthritis, psoriatic arthritis, gouty arthritis, symptomatic chondrocalcinosis, osteonecrosis, active infection), or peripheral or central neurological disorders (e.g., back pain, hip pain, disc herniation, sciatica, fibromyalgia, diabetic neuropathy, etc.) that, in the investigator’s judgment, may interfere with the assessment of pain and function of the target knee joint; 3. Severe varus/valgus deformity (>15°) or significant flexion contracture deformity (>5°) in the target knee joint; 4. Planned surgical treatment of any lower limb joint during the study period; 5. Current or past history of infectious arthritis in the target knee joint; 6. Active joint infection in the target knee or skin ulceration, infection, or any significant chronic skin disease at or around the injection site that may interfere with intra-articular injection and/or the evaluation of the injection site during the screening period; 7. Use of opioids or systemic corticosteroids within 30 days prior to screening, or a need for long-term opioid or systemic corticosteroid treatment during the study (e.g., patients with asthma requiring systemic corticosteroids are excluded; however, those requiring only inhaled corticosteroids may be included); 8. Intra-articular injection of any medication into either knee within 6 months prior to treatment initiation; 9. Symptomatic contralateral knee OA or hip OA that is not relieved by acetaminophen and requires withdrawal from the study for treatment; 10. Use of glucosamine, chondroitin sulfate, diacerein, or avocado/soybean unsaponifiables within 8 weeks prior to screening; 11. Contraindications to MRI examination, including but not limited to: implanted pacemakers, defibrillators, cardiac stents, artificial heart valves, post-aneurysm metal clips, drug infusion pumps, any implanted electronic devices (e.g., neurostimulators, bone growth stimulators), vascular embolization coils, filters, ECG monitors, metallic sutures, retained shrapnel or iron particles, internal fixation plates or screws, cochlear implants, middle ear prostheses, intraocular metal foreign bodies, etc.; as well as severe claustrophobia or critical illness; 12. Subjects currently undergoing systemic chemotherapy for any active malignancy; 13. Known or suspected allergy to any active or inactive component of the investigational product; 14. History of diagnosed psychiatric disorders or a history of substance abuse or drug addiction; 15. Pregnant or lactating women, women of childbearing potential who have not undergone sterilization, are not postmenopausal, or are unwilling to use medically approved effective contraception during the study; men who have not undergone sterilization or are unwilling to use effective contraception during the study; 16. Participation in any other clinical trial within 3 months prior to screening; 17. Any other condition that, in the investigator’s opinion, renders the subject unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety indexes; | — |
Secondary
| Measure | Time frame |
|---|---|
| WOMAC score;VAS score; | — |
Countries
China
Contacts
Public ContactYan Mengning
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed