Autologous Plasma Rich in Growth Factors (PRGF) Treating the Symptomatic Knee OA - Full Text View

Sponsored by:	Biotechnology Institute IMASD
Information provided by:	Biotechnology Institute IMASD
ClinicalTrials.gov Identifier:	NCT00782197

Purpose

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

Condition	Intervention	Phase
Joint Disease	Device: PRGF Intraarticular injection Device: Hyaluronic Acid Intraarticular injection	Phase IV

MedlinePlus related topics: Joint Disorders Osteoarthritis

Drug Information available for: Hyaluronic acid Hyaluronate Sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety of the Infiltration of Autologous Plasma Rich in Growth Factors (PRGF) in the Symptomatic Treatment of Knee Osteoarthritis

Further study details as provided by Biotechnology Institute IMASD:

Primary Outcome Measures:

Improvement in Womac pain subscore and visual analogue score from baseline and changes in Lequesne's algofunctional index. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Improvement of joint function (change in Womac OA index total score and function and stiffness subscores.) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Changes in Quality of life (SF-12 questionnaire). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Changes in Degree of joint mobility.(determined by goniometer). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complications and/or adverse effects. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	240
Study Start Date:	January 2008

Arms	Assigned Interventions
1: Experimental PRGF	Device: PRGF Intraarticular injection Three consecutive PRGF injections each one week apart.
2: Active Comparator Hyaluronic Acid	Device: Hyaluronic Acid Intraarticular injection Three consecutive Hyaluronic acid (EUFLEXXA) injections, each one week apart.

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.

Eligibility

Ages Eligible for Study:	40 Years to 72 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00782197

Contacts

Contact: Isabel Andia

isabel.andia@bti-imasd.com

Locations

Spain, Alava
UCA (Unidad de Cirugía Artroscopica Mikel Sanchez.) Clinica USP La Esperanza.	Recruiting
Vitoria, Alava, Spain
Contact: Mikel Sanchez
Principal Investigator: Mikel Sanchez
Spain, Gipuzkoa
Hospital Donostia.	Recruiting
San Sebastian, Gipuzkoa, Spain
Contact: Jaime Usabiaga
Principal Investigator: Jaime Usabiaga
Policlinica Gipuzkoa	Recruiting
San Sebastian, Gipuzkoa, Spain
Contact: Javier Albillos
Principal Investigator: Javier Albillos

Sponsors and Collaborators

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

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	BTI-01-EC/07/ART
Study First Received:	October 30, 2008
Last Updated:	October 30, 2008
ClinicalTrials.gov Identifier:	NCT00782197 History of Changes
Health Authority:	Spain: Ethics Committee

Keywords provided by Biotechnology Institute IMASD:

osteoarthritis
knee
PRGF

autologous plasma
plasma preparations
treatment

Study placed in the following topic categories:

Osteoarthritis, Knee
Immunologic Factors
Musculoskeletal Diseases
Hyaluronic Acid
Osteoarthritis

Arthritis
Joint Diseases
Adjuvants, Immunologic
Mitogens
Rheumatic Diseases

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Osteoarthritis
Hyaluronic Acid
Joint Diseases
Mitosis Modulators
Physiological Effects of Drugs

Adjuvants, Immunologic
Rheumatic Diseases
Pharmacologic Actions
Musculoskeletal Diseases
Arthritis
Mitogens

ClinicalTrials.gov processed this record on May 07, 2009