Osteoarthritis
Conditions
Interventions
Experimental group-2ml:Articular injection of adipose tissue MSCs-derived exosome 2ml
Experimental group-4ml:Articular injection of adipose tissue MSCs-derived exosome 4ml
Experimental group-6ml:Articular injection of adipose tissue MSCs-derived exosome 6ml
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Clinical diagnosis of symptoms and signs in patients with knee osteoarthritis; 2. Radiographic Kellgren-Lawrence grade of III-IV; 3. Male or female subjects aged 60 years above; 4. Continuous or intermittent Knee joint pain of at least 40mm of 100mm on visual analogue scale (average pain over 24 hours) for a period of 6 months; 5. Failed at least 3 weeks of conservative osteoarthritis care. Conservative treatment regimens may include any or all of the following: initial rest, medications e.g., anti-inflammatory, analgesics, narcotics/opioids, muscle relaxants, glucosamine, diacerein, opioids, hyaluronic acid, massage, acupuncture, osteopathic or chiropractic manipulations, activity modification, supervised physical therapy, therapeutic exercises, home-directed knee joint exercise and education programs, and non-invasive pain control treatments or procedures; 6. Combined with clinically significant cardiovascular (e.g. history of myocardial infarction, congestive heart failure or uncontrolled hypertension > 90 mmHg diastolic and/or 180 mmHg systolic), neurological (e.g. stroke, TIA) renal, hepatic or endocrine disease (e.g. diabetes); 7. Have the indication of joint replacement or arthroscopy but unwillingness to comply with the surgical procedure, or due to the combined the clinically significant multiple organ disorders; 8. Full understanding of the requirements of the study and willingness to comply with the treatment plan, including laboratory tests, diagnostic imaging, and follow-up visits and assessments.
Exclusion criteria
Exclusion criteria: 1. Subjects with acute inflammatory state of osteoarthritis; 2. Extreme obesity, as defined by NIH Clinical Guidelines Body Mass Index (BMI > 40); 3. Have undergone joint replacement or arthroscopy; 4. Active malignancy or tumor as a source of symptoms or history of malignancy within the 5 years prior to enrollment in the study; 5. Have undergone intra-articular injection of steroids in the past 4 weeks; 6. Have undergone any procedure using biological treatment for any condition such as bone marrow aspirate concentrate, PRP, bone marrow-derived MSCs, adipose-derived MSCs, SVF, micro fragmented fat, embryonic membrane product etc; 7. Taking systemic immunosuppressant medications within one year prior to enrollment or having a chronic, immunosuppressive state; 8. Taking anti-rheumatic disease medication (including methotrexate or other antimetabolites) within 3 months prior to study enrollment; 9. Ongoing infectious disease, including but not limited to tuberculosis, HIV, hepatitis, and syphilis; 10. Unexplained fever, defined as greater than 38.0 degrees Celsius; 11. History of or current evidence of alcohol or drug abuse or dependence; 12. Have a mental illness that could prevent completion of the study or protocol questionnaires.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS (Visual Analogue Scale) score;Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC);Barthel index;36-Item Short Form Survey (SF-36);Changes from Baseline evaluated by MRI;Changes in peripheral blood; | — |
Countries
China
Contacts
Public ContactQian Wang
West China Hospital, Sichuan University
Outcome results
None listed