Knee Osteoarthritis
Conditions
Interventions
hUC-MSCs:Local injection in the knee joint.The total number of cells is 5 × 10^7 and the volume is 2.5ml each time. The injection frequency is 2 times. The second injection is 3 weeks after the first
Sodium Hyaluronate:Local injection in the knee joint.The total number of sodium hyaluronate is 2.5mg and the volume is 2.5ml each time. The injection frequency is 2 times. The second injection is 3 we
Sponsors
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects understood the research procedures and methods, volunteered to participate in the trial, signed the informed consent, and able to communicate with the researchers and complete the study in accordance with the protocol. 2. The clinical diagnosis of the patient complied with the knee osteoarthritis diagnostic criteria prescribed by the Orthopedic Surgery Group of the COA (2018 version): 1)Repeated knee pain in the past month; 2)X-ray (standing or weight-bearing) show narrowing of the joint space, hardening of subchondral bone and / or cystic degeneration, and formation of osteophytes at the edge of the joint; 3)Aged >= 50 years; 4)Morning stiffness <= 30 minutes; 5)Bone fricative (sense) during activity. Note: Meeting the diagnostic criteria 1+ (any 2 of 2, 3, 4, 5) can diagnose knee osteoarthritis 3. The patient's clinical diagnosis complies with grades I-II in the Kellgren & Lawrence classification: Class i: slight osteophyte Grade II: Obvious osteophytes, with slight narrowing of joint space Class iii: Moderately narrow joint space Grade iv: Significant narrowing of the joint space and subchondral bone hardening 4. When randomized, the age is <= 70 years, the gender is not limited.
Exclusion criteria
Exclusion criteria: 1. Patient's clinical diagnosis complies with Kellgren-Lawrence classification III-IV. 2. Have other diseases that can cause knee pain, such as anterior cruciate ligament tear, meniscal tear, villous nodular synovitis, synovial chondromatosis, traumatic arthritis, infectious diseases, etc. MRI examination should be done if necessary. 3. Received any of the following treatments within 4 weeks before the first treatment: opioid analgesics, non-steroidal antipyretic analgesics or oral proprietary Chinese medicines; unilateral or bilateral knee joint physical therapy or exercise therapy; unilateral or bilateral Traditional Chinese medicine for external use or acupuncture and moxibustion, etc. 4. Received any of the following treatments within 8 weeks before the first treatment: glucocorticoidsinjections, anesthetic injections in unilateral or bilateral knee joint cavity, or external glucocorticoids; glucocorticoids for any reason at any location, such as oral, external, suppositories, etc. 5. Received any of the following treatments within 24 weeks before the first treatment: unilateral or bilateral knee joint biotherapy, including stem cell therapy, platelet-rich plasma (PRP) injection therapy, etc.; unilateral or bilateral knee joint cavity sodium hyaluronate injection treatment. 6. Those who have had a high tibial osteotomy, or those who underwent knee surgery within 12 months before screening. 7. Complicated with systemic or rheumatic diseases. 8. Patients who are unable to understand the content of the study materials or who cannot undergo clinical, imaging, and laboratory evaluations. 9. Patients who have a skin disease or infection in the area of the injection site and who are at risk for infection by the injection. 10. Patients with severe malnutrition (MNA-SF score <= 11), heart, lung, liver, kidney and other important organs and endocrine system disease history, or patients with syphilis and HIV test positive. 11. Those who are known to be allergic to the components of this treatment. 12. Pregnant, suspicious pregnancy, lactating female patients or patients (including men and women) who refused to use contraception during the study. 13. Currently have or have a history of malignancy within 5 years prior to signing the informed consent. 14. Those who have participated in any drug or medical device clinical trial within 3 months before screening. 15. Other subjects determined by the investigator to be inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| WOMAC score;KSS score;VAS score; | — |
Secondary
| Measure | Time frame |
|---|---|
| EQ-5D score;MRI and X-ray; | — |
Countries
China
Contacts
Public ContactYue Ding
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Outcome results
None listed