knee osteoarthritis
Conditions
Interventions
Group 1:Umbilical cord mesenchymal stem cells (Low dose)
Group 2:Umbilical cord mesenchymal stem cells(Medium dose)
Group 3:Umbilical cord mesenchymal stem cells(High dose)
Control group:Saline
Sponsors
The Second Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects who are willing to sign the informed consent and follow the requirements of the research protocol, the subjects can understand and complete the research questionnaire; 2. Aged 40-70 years; 3. ACR-compliant knee osteoarthritis, symptoms lasting at least 3 months (can be confirmed at screening); 4. Imaging X-rays Kellgren & Lawrence grades 2-3. (KL classification standard: Grade 1 slight osteophyte; Grade 2 obvious osteophyte, but joint space is not involved; Grade 3 joint space is moderately narrow; Grade 4 joint space is significantly narrowed and subchondral bone is hardened); 5. Subjects with affected joints had a baseline pain score of moderate or severe pain (VAS >= 40 mm); 6. The affected joint is unilateral knee joint; 7. When screening, if the subject is taking non-steroidal anti-inflammatory drugs (NSAIDs), the dose should be stable for at least 2 weeks before the first administration; 8. Women of childbearing period or menopause for less than 2 years; 9. The researcher believes that the subject needs to be treated with NSAIDs and is expected to continue to be treated with NSAIDs for more than 8 weeks; 10. There were no new cardiovascular and cerebrovascular diseases within 6 months, including: unstable angina pectoris, acute myocardial infarction, acute cerebral ischemia and cerebral infarction. Patients with hypertension who have achieved stable drug control can be selected.
Exclusion criteria
Exclusion criteria: 1. Secondary osteoarthritis, the past history of the target joint observed and / or any evidence of: pyogenic arthritis, inflammatory joint disease, gout, recurrent pseudogout, Paget's bone disease, Joint fractures, yellow brown disease, acromegaly, hemochromatosis, Wilson's disease, primary osteochondroma, genetic diseases (such as ADHD), and mutations in collagen genes; 2. Accompanied by other rheumatic diseases, including (but not limited to) such as systemic lupus erythematosus, inflammatory bowel disease, Felty syndrome, scleroderma, inflammatory myopathy or other connective tissue disease, overlap syndrome, etc.); 3. Those who have received intra-articular injections within 12 weeks; 4. Those who have undergone arthroscopy, orthopedics or total arthroplasty within 6 months; 5. Those who need arthroplasty; 6. Those who use anticoagulants (such as warfarin, low molecular weight heparin) and antiplatelet aggregation drugs; 7. Patients with or with a history of tumor diseases; 8. Severe poorly controlled diseases, such as diabetes, hypertension, kidney disease, liver disease, or severe heart disease (eg, moderate to severe congestive heart failure (New York Heart Association Heart Function Grade III / IV)) , And the researcher judges that it is not suitable to join the study; 9. Laboratory test results are abnormal: Blood routine: 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 value, with creatinine clearance < 50 ml / min (measured value, or calculated by Cockcroft-Gault formula); HIVAb-positive, HBsAg-positive, HBcAb-positive, HCVAb-positive, and syphilis antibody positive (any test result is excluded) 10. Participants in clinical trials of other drugs within 3 months before screening; 11. Have received arterial or intramuscular or intravenous corticosteroids within 4 weeks before screening; 12. Women during pregnancy, breastfeeding and preparing for pregnancy; 13. Those who have used stem cell therapy within six months; 14. People with mental disorders or uncontrolled and poorly controlled mental illnesses; 15.Persons in medical proceedings 16. People with a history of alcohol and drug abuse, and allergies or history of allergies; 17. Patients who the investigator considers unsuitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| WOMAC Osteoarthritis Index Score;Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS Score;knee society score;Short Form 12 Health Survey;radiographic data; | — |
Countries
China
Contacts
Public ContactHuang Wenhui
The Second Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed