Autologous Adipose Tissue Derived Mesenchymal Stem Cells Therapy for Patients With Knee Osteoarthritis by Intra-articular Injection: A PhaseⅠ/Ⅱa, Randomized and Double-blinded Clinical Trial

Fecha de inicio: 1 de marzo de 2013

Inclusion Criteria: Subjects who understand and sign the consent form for this study. Age: 40-70, males and females. Clinical diagnosis of degenerative arthritis by Radiographic Criteria of Kellgren and Lawrence. Patients who can't treat with traditional medication and need a arthroplasty. Duration of pain over Grade 4(11-point numeric scale)> 4 months. Exclusion Criteria: Women who are pregnant or breast feeding or planning to become pregnant during the study. Objects who administer with a anti-inflammatory drugs within 14 days prior to inclusion in the study. History or current evidence of alcohol or drug abuse or is a recreational user of illicit drugs or prescription medications. Treatment with intra-articular injection therapy within 2 months prior to screen. Other joint diseases except degenerative arthritis : systemic or rheumatic or inflammatory chondropathy, chondrocalcinosis, hemachromatosis, inflammatory joint disease, avascular necrosis of the femoral head, Paget's disease, hemophilic arthropathy, infectional arthritis, Charcot's disease, villonodular synovitis, synovial chondromatosis. Positive serology for HIV-1 or HIV-2, Hepatitis B (HBsAg, Anti-HCV-Ab), Hepatitis C (Anti-HCV-Ab) and syphilis. Serious pre-existing medical conditions like Cardiovascular Diseases, Renal Diseases, Liver Diseases, Endocrine Diseases, Cancer and Diabetes Mellitus. Overweight expressed as body mass index (BMI) greater than 30 (obesity grade II). Participation in another clinical trial or treatment with a different investigational product within 3 months prior to inclusion in the study. Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria.