NCT00782197

Autologous Plasma Rich in Growth Factors (PRGF) Treating the Symptomatic Knee OA

Efficacy and Safety of the Infiltration of Autologous Plasma Rich in Growth Factors (PRGF) in the Symptomatic Treatment of Knee Osteoarthritis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Biotechnology Institute IMASD · Industry
• Sex: All
• Age: 40 Years – 72 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of PRGF infiltrations in the treatment of knee osteoarthritis.

Detailed description

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.

Conditions

• Joint Disease

Interventions

Type	Name	Description
DEVICE	PRGF Intraarticular injection	Three consecutive PRGF injections each one week apart.
DEVICE	Hyaluronic Acid Intraarticular injection	Three consecutive Hyaluronic acid (EUFLEXXA) injections, each one week apart.

Timeline

• Start date: 2008-01-01
• First posted: 2008-10-31
• Last updated: 2010-10-04

Locations

3 sites across 1 country: Spain