degenerative osteoarthritis articular cartilage defects of the knee
Conditions
Interventions
Treatment :intra-articular injection of mesenchymal stem cells combined with platelet rich plasma
Control :intra-articular injection of platelet rich plasma
Sponsors
Renmin Hospital, Hubei University of Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosis of Knee Osteoarthritis according to the criteria of osteoarthritis of the ACR (American College of Rheumatology). 2. Radiographic evidence of grade 2 to 4 osteoarthritis based on the Kellgren-Lawrence radiographic entry criteria. 3. Confirm with cartilage injury, articular cartilage part or full-thickness injury, via MRI. 4. Males or females age >18 years and the ability to understand the treatment plan. 5. Over 6 months/2 years knee pain and lack of effective with conservative treatments. 6. Knee pain of VAS (visual analog scale score) is 4 or higher. 7. Normal hepatic and renal function, no history of gout, rheumatoid arthritis, and autoimmune diseases, and no serious organ dysfunction. 8. Patients willing to participate and follow up in this clinical trial; Understand and sign the consent form of this study. 9. Ability to tolerate liposuction. 10. There was no obvious abnormality in tumor marker detection, or patient was evaluated and has no risk of cancer.
Exclusion criteria
Exclusion criteria: 1. Pregnant or considering pregnancy in the next 6-month, lactating. 2. Positive tests for HIV, HCV, HBV and syphilis. 3. Uncontrollable or difficult to control/uncontrolled/poor controlled cardiovascular and cerebrovascular, liver, kidney, lung, endocrine and other systematic diseases with a life expectancy of less than 1 year. 4. History of malignancy. 5. Serious systemic or local knee infection (including skin and lumen infection) within 3 months prior to this study. 6. Underwent arthroscopy or knee related surgery within half year. 7. Subjects received intra-articular drug injection for knee osteoarthritis within 6 months before the start of the study, including but not limited to corticosteroid, hyaluronic acid, hormone, PRP, BMP, etc. 8. Subjects had alcoholism, drug abuse or mental illness within 3 years prior to this study. 9. Body Mass Index (BMI) of 30 kg/m2 or greater./Overweight expressed as body mass index (BMI) >35 10. Patient participating in another clinical study within 3 months of this study. 11. Serious bleeding tendency, poor coagulation function (PTA <35%). 12. The investigator realizes the patient is unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse effects;Knee cartilage volume; | — |
Secondary
| Measure | Time frame |
|---|---|
| WOMAC score;Visual Analogue Scale;VascuQol;Kellgren-Lawrence Grading Scale; | — |
Countries
China
Contacts
Public ContactBin Zhou
Renmin Hospital, Hubei University of Medicine
Outcome results
None listed