osteoarthritis
Conditions
Interventions
experimental group:injection
Sponsors
Tsinghua University Yuquan Hospital (Tsinghua University Integrated Traditional Chinese and Western Medicine Hospital)
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Subjects who are willing to sign the informed consent and follow the requirements of the study protocol can understand and complete the study questionnaire; 2. Age 40-70, male or female; 3. Osteoarthritis that meets ACR criteria, symptoms lasting for at least 3 months (may be diagnosed at screening time); 4. Radiographic X-rays were graded 2-3 by Kellgren & Lawrence. KL grading criteria: Grade 1 slight osteophyte; Grade 2 osteophytes were evident, but no joint space was involved. Grade 3 moderate joint space stenosis; Grade 4 joint space narrowing, subchondral sclerosis); 5. Subjects' baseline pain score for the affected joint was moderate or severe pain (VAS >= 40mm); 6. At the time of screening, if subjects were taking non-steroidal anti-inflammatory drugs (NSAIDs), the dose was stable for at least 2 weeks prior to initial administration; 7. Women with less than 2 years of childbearing or menopause; 8. The investigator considers that the subject needs to be treated with NSAIDs, and it is expected that the subject will be treated with NSAIDs continuously for more than 8 weeks; 9. No new cardiovascular and cerebrovascular diseases occurred within 6 months, including unstable angina pectoris, acute myocardial infarction, acute cerebral ischemia, and cerebral infarction. Patients with stable hypertension under drug control could be included.
Exclusion criteria
Exclusion criteria: 1. Secondary osteoarthritis, where the observed target joint has a past history and/or any evidence of Suppurative arthritis, inflammatory joint disease, gout, recurrent pseudocygout, Paget's bone disease, joint fractures, yellow-brown disease, acromegaly, haematochromia, Wilson's disease, primary osteochondroma, hereditary disorders (e.g., ADHD) and collagen gene mutations; 2. Presence of other rheumatic diseases, including (but not limited to) systemic lupus erythematosus, inflammatory bowel disease, Felty syndrome, scleroderma, inflammatory myopathy or other connective tissue diseases, overlapping syndrome, etc; 3. Patients who received intraarticular drug injection within 12 weeks; 4. Those who have had arthroscopy, orthosis, or total joint replacement within 6 months; 5. Those who need arthroplasty; 6. Use of anticoagulants (such as warfarin, low molecular weight heparin) and antiplatelet aggregation drugs; 7. Patients with tumor diseases or a history of tumor diseases; 8. have a serious and poorly controlled disease, such as diabetes, hypertension, kidney disease, liver disease, or serious heart disease (e.g., moderate to severe congestive heart failure (Ny Cardiology Class III/CLASS IV)), and are not eligible for inclusion in the study as determined by the investigator; 9. Abnormal laboratory results: Blood routine examination: WBC 1.5 times the upper limit of normal value; ALT or AST > 2.5 times the upper limit of normal value; Renal function: creatinine > 1.5 times the upper limit of normal, with creatinine clearance < 50 mL /min (measured or calculated by the Cockcroft-Gault formula); HIVAb positive, HBsAg positive, HBcAb positive, HCVAb positive, syphilis antibody positive (any positive results will be excluded); 10. Participants in clinical trials of other drugs within 3 months prior to screening; 11. Received articular or intramuscular or intravenous corticosteroid injections within 4 weeks prior to screening; 12. Women who are pregnant, breastfeeding, and preparing for pregnancy; 13. Those who have used stem cell therapy within six months; 14. Mental disorders or uncontrolled and poorly controlled mental diseases; 15. Those in the process of medical litigation; 16. People with a history of alcohol or drug abuse and allergies or allergies; 17. Patients considered unsuitable for the clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical efficacy evaluation;Joint function score;X-ray, quality of life score;Laboratory index; | — |
Countries
China
Contacts
Public ContactCui Zhiqiang
Outcome results
None listed