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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00782197
• Other study ID #: BTI-01-EC/07/ART
• Status: Completed
• Phase: Phase 4
• First received: October 30, 2008
• Last updated: October 1, 2010
• Start date: January 2008

Study information

• Verified date: October 2010
• Source: Biotechnology Institute IMASD
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 72 Years

Eligibility

Inclusion Criteria:

• Patients of both sexes and aged between 40 and 72 years.

• Diagnosed with osteoarthritis of the knee by radiological image.

• Pain in the joint equal to or greater than 2.5 points in EAV.

• Radiological severity:Value in the Ahlback score 3 or less.

• Body mass index between 20 and 30.

• Possibility for observation during follow-up period.

Exclusion Criteria:

• Bilateral Gonarthrosis requiring infiltration in both knees.

• Body mass index greater than 30.

• Diagnosed polyarticular disease.

• Severe mechanical deformation.

• Previous arthroscopy in the past year.

• Intraarticular infiltration of hyaluronic acid in the last 6 months.

• Rheumatic autoimmune systemic disease.

• Poorly controlled diabetes mellitus.

• Blood alterations.

• Immunosuppressive treatments and/or coumarinics.

• Treatment with steroids for 3 months prior to its inclusion in the study.

• Treatment with nonsteroidal anti-inflammatory drugs for 15 days prior to its inclusion in the study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Joint Disease
• Joint Diseases

Intervention

Device:
• PRGF Intraarticular injection
Three consecutive PRGF injections each one week apart.
• Hyaluronic Acid Intraarticular injection
Three consecutive Hyaluronic acid (EUFLEXXA) injections, each one week apart.

Locations

Country	Name	City	State
Spain	Hospital Donostia.	San Sebastian	Gipuzkoa
Spain	Policlinica Gipuzkoa	San Sebastian	Gipuzkoa
Spain	UCA (Unidad de Cirugía Artroscopica Mikel Sanchez.) Clinica USP La Esperanza.	Vitoria	Alava

Sponsors (1)

Lead Sponsor	Collaborator
Biotechnology Institute IMASD

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in Womac pain subscore and visual analogue score from baseline and changes in Lequesne's algofunctional index.		6 months	No
Secondary	Improvement of joint function (change in Womac OA index total score and function and stiffness subscores.)		6 months	No
Secondary	Changes in Quality of life (SF-12 questionnaire).		6 months	No
Secondary	Changes in Degree of joint mobility.(determined by goniometer).		6 months	No
Secondary	Complications and/or adverse effects.		6 months	Yes

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