PRGF Intraarticular injection
DeviceThree consecutive PRGF injections each one week apart.
NCT Number: NCT00782197
The purpose of this study is to evaluate the efficacy and safety of PRGF infiltrations in the treatment of knee osteoarthritis.
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Notify Me40 year–72 year
All sexes
Interventional
Phase 4
UCA (Unidad de Cirugía Artroscopica Mikel Sanchez.) Clinica USP La Esperanza., Vitoria-Gasteiz, Alava, Spain
Several studies have shown the positive effects of the autologous "Preparation Rich in Growth Factors" (PRGF) in different clinical situations involving connective tissues and also in OA synovial cells. PRGF is a biological delivery system of a complex mixture of bioactive proteins essential to natural repair including anabolic factors for cartilage such as transforming growth factor-β1 (TGF-β1), platelet-derived growth factor (PDGF) and insulin-like growth factor (IGF-I). The potential of PRGF to enhance the limited capacity of cartilage to repair itself encouraged the idea of treating degenerative joint conditions with this autologous preparation.
The present study was undertaken to assess the efficacy and safety of the intra-articular injection of PRGF and to obtain useful information about the clinical effects. Since pain is the most pressing problem facing people with OA, a significant improvement in pain would indicate the potential of the proposed treatment. We will also evaluate functionality and quality of life. In addition we will examine changes in novel serum and synovial fluid biomarkers and their correlation with MRI-based parameters in a subgroup of patients.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Three consecutive PRGF injections each one week apart.
Three consecutive Hyaluronic acid (EUFLEXXA) injections, each one week apart.
Time frame: 6 months
Time frame: 6 months
Time frame: 6 months
Time frame: 6 months
Time frame: 6 months
Biotechnology Institute IMASD
Industry
Efficacy and Safety of the Infiltration of Autologous Plasma Rich in Growth Factors (PRGF) in the Symptomatic Treatment of Knee Osteoarthritis
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