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

October 1, 2010 updated by: Biotechnology Institute IMASD

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Alava
      • Vitoria, Alava, Spain
        • UCA (Unidad de Cirugía Artroscopica Mikel Sanchez.) Clinica USP La Esperanza.
    • Gipuzkoa
      • San Sebastian, Gipuzkoa, Spain
        • Hospital Donostia.
      • San Sebastian, Gipuzkoa, Spain
        • Policlinica Gipuzkoa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 72 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
PRGF
Device: PRGF Intraarticular injection
Three consecutive PRGF injections each one week apart.
Active Comparator: 2
Hyaluronic Acid
Device: Hyaluronic Acid Intraarticular injection
Three consecutive Hyaluronic acid (EUFLEXXA) injections, each one week apart.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement in Womac pain subscore and visual analogue score from baseline and changes in Lequesne's algofunctional index.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement of joint function (change in Womac OA index total score and function and stiffness subscores.)
Time Frame: 6 months
6 months
Changes in Quality of life (SF-12 questionnaire).
Time Frame: 6 months
6 months
Changes in Degree of joint mobility.(determined by goniometer).
Time Frame: 6 months
6 months
Complications and/or adverse effects.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotechnology Institute IMASD

Investigators

  • Principal Investigator: Mikel Sanchez, UCA (Unidad de Cirugía Artroscópica Mikel Sanchez). USP Clínica la Esperanza. C/LA Esperanza 3, 01002 Vitoria (Alava)SPAIN.
  • Study Director: Jaime Usabiaga, Hospital Donostia
  • Study Director: Javier Albillos, Policlinica Gipuzkoa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Study Registration Dates

First Submitted

October 30, 2008

First Submitted That Met QC Criteria

October 30, 2008

First Posted (Estimate)

October 31, 2008

Study Record Updates

Last Update Posted (Estimate)

October 4, 2010

Last Update Submitted That Met QC Criteria

October 1, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BTI-01-EC/07/ART

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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