Knee osteoarthritis
Conditions
Interventions
Group A:3×10^10 particles/2 mL exosomes
Group B:3×10^11particles/2 mL exosomes
Sponsors
Shenzhen Longgang District Maternity &Child Healthcare Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. The patient's clinical diagnosis meets the diagnostic criteria for knee osteoarthritis (KOA) as stipulated in the Guidelines for the Diagnosis and Treatment of Osteoarthritis of the Knee Joint (2018 Edition) issued by the Joint Surgery Group of the Orthopedics Branch of the Chinese Medical Association. The diagnosis of KOA can be made if there is recurrent knee pain within the past month and any two of the following conditions are present: X-ray film (standing or weight-bearing position) showing joint space narrowing, subchondral bone sclerosis and/or cystic degeneration, and osteophyte formation at the joint margin;age >=50 years;morning stiffness time <=30 minutes;and bone friction sound (sensation) during activity. 2. The patient's clinical diagnosis conforms to grades I-II according to the Kellgren & Lawrence classification system (mild osteophyte;obvious osteophyte, but not involving the joint space). 3. The patient is aged 18 to 85 years, with no gender restrictions.
Exclusion criteria
Exclusion criteria: 1. It is proposed to study patients with lateral knee joints classified as Kellgren-Lawrence grade III-IV (moderate narrowing of joint space; 1.Significant narrowing of joint space, with subchondral bone sclerosis); 2. Suffering from other diseases that may cause knee joint pain, such as anterior cruciate ligament tear, meniscus tear, villonodular synovitis, synovial chondromatosis, traumatic arthritis, infectious diseases, etc; 3. Patients who have received analgesics, traditional Chinese patent medicines and simple preparations, physical therapy or exercise therapy, or traditional Chinese medicine therapy within 4 weeks before the first treatment; 4. Patients who have received intra-articular injections of glucocorticoids or anesthetics, or oral or topical administration of glucocorticoids within 8 weeks prior to the initial treatment; 5. Patients who have received knee joint biotherapy (including stem cell therapy, platelet-rich plasma (PRP) injection) or knee joint sodium hyaluronate injection within 24 weeks before the first treatment; 6. Those who have undergone high tibial osteotomy, or those who have undergone other knee surgeries within the previous 12 months prior to screening; 7. Concurrent systemic or rheumatic diseases, etc; 8. Patients who are unable to comprehend the content of the research materials or who cannot undergo clinical, radiological, and laboratory evaluations; 9. Patients who have skin diseases or infections in the injection site area, thereby posing a risk of infection during injection; 10. Individuals with severe malnutrition (MNA-SF score <=11), significant organ damage such as heart, lung, liver, and kidney, as well as abnormalities and history of blood and endocrine systems, or individuals with positive results in syphilis or HIV tests; 11. Known allergies to exosome components; 12. Female patients who are pregnant, possibly pregnant, or breastfeeding, or patients (both male and female) who refuse to use contraception during the study period; 13. Currently suffering from or having a history of malignant tumor within 5 years prior to signing the informed consent form; 14. Those who have participated in any clinical trials of drugs or medical devices currently or within 3 months before screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| WOMAC Score; | — |
Countries
China
Contacts
Public ContactWei Fengxiang, Zhou Guanglin
Shenzhen Longgang District Maternity &Child Healthcare Hospital
Outcome results
None listed