Knee osteoarthritis
Conditions
Interventions
Low dose group:Allogeneic Human Adipose-derived Mesenchymal Stem Cells Exosomes(Low dose group 1.25×10^11)
High dose group:Allogeneic Human Adipose-derived Mesenchymal Stem Cells Exosomes(High dose group 5×10^11)
Medium dose group:Allogeneic Human Adipose-derived Mesenchymal Stem Cells Exosomes(Medium dose group 2.5×10^11)
Sponsors
The first people's Hospital of Yunnan Province
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Patients diagnosed with knee osteoarthritis (according to the "2021 Osteoarthritis Diagnosis and Treatment Guidelines" by the Orthopaedic Society of the Chinese Medical Association); 2.Kellgren-Lawrence grade II to III; 3.Age between 18-75 years old; 4.VAS pain score (Visual Analog Scale) of 4 or above, and WOMAC pain score >= 2 points; 5.The target knee joint has chronic pain that lasts for at least 3 months, or has poor, intolerable, or unresolvable effects after 3 months of physical/medication treatment; 6.Willing to follow the treatment plan and sign the informed consent form;
Exclusion criteria
Exclusion criteria: 1. Acute inflammatory phase; 2. BMI > 40; 3. History of joint replacement surgery or arthroscopic surgery; 4. Presence of other joint diseases or diseases causing knee pain, such as rheumatoid arthritis, suppurative arthritis, ankylosing spondylitis, anterior cruciate ligament tear, meniscus tear, villonodular synovitis, synovial chondromatosis, traumatic arthritis, infectious diseases, etc.; 5. Presence of systemic diseases, such as uncontrolled severe systemic diseases, tumors, etc.; 6. Intra-articular steroid injection in the knee within 4 weeks; 7. Received stem cell or other biological treatments within the past year; 8. Systemic immunosuppressive medication use within the past year; 9. Use of antirheumatic drugs within the past 3 months (including methotrexate or other antimetabolic drugs); 10. Infectious diseases such as pulmonary tuberculosis, HIV, hepatitis, and syphilis; 11. Fever of unknown origin > 38.0 ?; 12. History of alcohol or drug abuse; 13. Moderate to severe anxiety, depression, or other psychological disorders; 14. Known allergy to any component of the study drug; 15. Does not understand Mandarin or cannot recognize Chinese characters.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events;Incidence of dose-limiting toxicity;Immunological indicators; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety indicators(Immunological indicators, inflammatory indicators, laboratory tests, vital signs, physical examination);Knee joint pain and functional improvement;Slowing down or inhibiting cartilage degeneration in knee joint osteoarthritis;Exploratory efficacy endpoint (to assess changes in cartilage degradation markers related to cartilage metabolism and inflammation (C-terminal telopeptide of type II collagen (CTX-II)) levels); | — |
Countries
China
Contacts
Public ContactHou Jianhong
The first people's Hospital of Yunnan Province
Outcome results
None listed