Joint Disease Clinical Trial
Official title:
Efficacy and Safety of the Infiltration of Autologous Plasma Rich in Growth Factors (PRGF) in the Symptomatic Treatment of Knee Osteoarthritis
The purpose of this study is to evaluate the efficacy and safety of PRGF infiltrations in the treatment of knee osteoarthritis.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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