Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-25 @ 12:59 AM
NCT ID:
NCT02162693
Eligibility Criteria:
Inclusion Criteria:
1. The subject is between 18-70 years of age, regardless of gender
2. The subject has a Kellgren-Lawrence grading, as determined by American College of Rheumatology (ACR) criteria for osteoarthritis of the knee, below grade 4
3. The subject or the subject's legally acceptable representative must be willing to participate in the trial, to receive cell therapy and to provide signed and dated informed consent forms
Exclusion Criteria:
1. The subject has an allergic history or is of an allergic constitution
2. The subject has uncontrolled or hard-to-control diseases of heart, liver, kidney or lung
3. The subject has uncontrolled or hard-to-control diseases of cardiovascular or endocrine system
4. The subject has severe infectious diseases or a malignant tumour
5. The subject has coagulation disorders
6. The subject has a BMI of over 30
7. The subject has used traditional Chinese medicine containing anti-inflammatory agents in the 2 weeks preceding the trial
8. The subject has received other intra-articular injections in the 2 months preceding the trial
9. The subject has complications or diseases of: systemic or rheumatoid arthritis, Chondrocalcinosis articular， Hemochromatosis，inflammatory arthropathy，avascular necrosis of femoral head，Paget's disease，hemophilic arthropathy，infectional arthritis，Charcot's disease，villonodular synovitis or synovial chondromatosis
10. The subject tests positive for: HIV, hepatitis virus, syphilis or other infectious diseases
11. The subject has a history of alcoholism, drug abuse, or mental illness
12. The subject has participated in any other clinical trial in the 3 months prior to this trial
13. The subject is pregnant, lactating or is planning to conceive within the next 6 months
14. The subject has any other unsuitable or adverse condition to be determined by the investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02162693
Study Brief:
Protocol Section:
NCT02162693