Intraarticular and intraosseus application of plasma rich in growth factors in patients with knee osteoarthritis to improve movility and pai

Phase 1

Conditions: Knee osteoarthritis.
MedDRA version: 20.0Level: PTClassification code 10031161Term: OsteoarthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

Registration Number: EUCTR2017-000623-27-ES

Lead Sponsor: Fundacion para la investigacion biomedica HUPA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Age between 40 and 75.
Both genders.
Moderate to several pain and symptoms according to the KOOS scale of more than 6 months of evolution.
Grade III- IV knee osteoathritis according to radiological criteria for the classification of Kellgren and Lawrence.
Patients with no response to other pharmacological treatments.
Able to fulfill the schedule of visits of the trial.
BMI less than 35.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 86
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 48

Exclusion Criteria

Intraarticular infiltration with plasma rich in growth factors in the 12 months before the inclusion
Intraarticular infiltration with hyaluronic acid in the 6 months before the inclusion.
Angular alterations, higher than 15 degrees and unstable joint.
Systemic or local infectious disease and polyarticular disease.
Cancer under treatment or under follow-up.
Immunosuppressive treatment or systemic autoimmune disease.
Patient with hypertension or diabetes mellitus poorly controlled.
Allergy to some study drugs or excipients.
Patients on anticoagulants or antiplatelet therapy which cannot be reversed temporarily for infiltrations.
Positive to sifilis, hepatitis B, hepatitis C or VIH+.
Uncapable to understand or fulfill the questionnaries of the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: To evaluate the effectiveness at 12 months measured in the KOOS scale<br>To evaluate the effectiveness at 6 and 12 months measured in the WOMAC scale<br>To assess radiological changes in the subchondral bone<br>To asses the safety of the administration of plasma rich in growth factors;Primary end point(s): Score at 6 months in the KOOS scale;Timepoint(s) of evaluation of this end point: 6 months;Main Objective: The main objective is to assess the effectiveness at 6 months, defined as improvement in the functionality and pain mesaured in the KOOS scale, of the intraarticular and intraosseus application of plasma rich in growth factors versus the intraarticular application of plasma rich in growth factors plus intraosseus administration of placebo.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Score at 12 months in the KOOS scale<br>Score at 6 and 12 months in the WOMAC scale;Timepoint(s) of evaluation of this end point: 6 and 12 months