degenerative knee arthritis
Conditions
Interventions
Experimental group:Single intra-articular injection of BBM-A101 injection into the knee joint,2ml
Sponsors
Shenzhen Second People's Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. meeting the diagnostic standards of Knee Osteoarthritis. 2. Aged 40-75, male or female; 3. Kellgren-Lawrence grade 2–3 in the target knee; 4. BMI between 18.0 - 35.0 kg/m2; 5. Appropriate pre-existing AAV antibody titer; 6. WOMAC pain score in appropriate range; 7. demonstrating willingness to maintain highly effective contraception from screening until 52 weeks after administration. 8. having good compliance with the ability to adhere to scheduled follow-up visits; 9. demonstrating willingness not to participate in any other interventional clinical trials for the duration of this study; 10. having ability to understand and voluntarily provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of immune-mediated inflammatory arthropathies (e.g., rheumatoid arthritis, psoriatic arthritis, gout) or other forms of secondary arthritis; 2. Moderate to severe pain in the contralateral knee or ipsilateral hip within the 3 months preceding screening; 3. Any intra-articular injection into the target knee within the previous 3 months; 4. A history of prior gene therapy or stem cell treatment; 5. A history of significant knee injury (e.g., ligament tear or sprain) within 12 months; 6. Radiographic evidence of bony malalignment (>10° varus or valgus); 7. Presence of cutaneous lesions (e.g., infection, wound) on the target knee within 30 days prior to screening; 8. Having severe hip osteoarthritis ipsilateral to the target knee. 9. Presence of a disability severe enough to preclude compliance with study requirements, including knee symptoms that cause significant difficulty or inability to walk. 10. History of any cartilage repair procedure (e.g., surgical or pharmacological interventions aimed at cartilage regeneration or delaying cartilage wear). 11. Recent knee surgery (=6 months) or planned surgical intervention during the study period; 12. Blood donation or blood loss exceeding 400 mL in the past 60 days; 13. Current pregnancy or lactation, or intention to become pregnant within 52 weeks; 14. Concomitant knee fracture or tumor; 15. Any contraindication to MRI (e.g., metallic implants, allergy to gadolinium). 16. Clinically significant laboratory abnormalities, including leukopenia (WBC 2 times the upper limit of normal), or hyperbilirubinemia (>2 mg/dL); renal impairment (estimated glomerular filtration rate <60 mL/min); 17. Recent use of prohibited medications, defined as systemic glucocorticoids , oral NSAIDs, glucosamine/chondroitin supplements; 18. Positive serology for HBV, HCV, HIV, or syphilis; 19. Presence of coagulopathy (unless INR was maintained below 3); 20. Vaccination within 30 days before or after dosing; 21. Clinically significant electrocardiogram (ECG) abnormalities; 22. Unstable cardiovascular disease; 23. A history of malignancy within the past 5 years (with the exception of adequately treated non-invasive lesions); 24. Active alcohol or substance dependence; 25. or unstable psychiatric disorders (e.g., severe depression, schizophrenia).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs);Any clinically significant physical examinations, vital signs, electrocardiograms, and laboratory tests during the treatment period.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Numerical Rating Scale (NRS);Knee Injury and Osteoarthritis Outcome Score (KOOS);The Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC); | — |
Countries
China
Contacts
Public ContactSun Wei
Shenzhen Second People's Hospital (The First Affiliated Hospital of Shenzhen University)
Outcome results
None listed