Immuno-based Profiling of knEe OA Patients to Predict reSponse to Regenerative Treatment

NCT ID: NCT06384040

Last Updated: 2024-04-30

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 105 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2024-10-30

Brief Summary

Osteoarthritis (OA) is a highly prevalent degenerative musculoskeletal disease and a major cause of chronic disability worldwide. Its multifactorial origin contributes to determine the heterogeneous phenotypes and one unmet need is the lack of biomarkers to predict the individual response. Platelet-rich-plasma (PRP) injection is a minimally invasive autologous blood-derived approach for which we plan to define specific knee profiles predictive of response. We will take advantage of a unique multidisciplinary approach aimed at analysing clinics, imaging, and biomarkers of associated with clinical response. We will focus on inflammatory (Wnt system, IL1 pathway, PTX3) and antioxidant (primarily, DPP3/Keap1/Nrf2) pathways. We foresee that our results will allow a better allocation of immunomodulatory and regenerative therapies for a personalized approach in knee OA thus maximising the effectiveness of the healthcare allocation.

Conditions

Osteoarthritis, Knee

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

PRP responder

response to treatment will be established in the presence of \>40% improvement of pain and/or motility

platelet-rich plasma knee injection

Intervention Type: PROCEDURE

platelet-rich plasma knee injection and observation for 12 months for definition of responder and non responder

PRP non responder

response to treatment will be established in the presence of \<40% improvement of pain and/or motility

platelet-rich plasma knee injection

Intervention Type: PROCEDURE

platelet-rich plasma knee injection and observation for 12 months for definition of responder and non responder

Interventions

platelet-rich plasma knee injection

platelet-rich plasma knee injection and observation for 12 months for definition of responder and non responder

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• men/women, aged >40 - <75 years), OA grade 2-3, BMI <40, baseline WOMAC PAIN >1.75 -<4, >1 conservative therapy failed. Diagnosis of knee OA according to the American College of Rheumatology (ACR) classification criteria (Altman, 1986) .
• Ability to give informed consent.

Exclusion Criteria

• Presence of active infection or abnormal knee effusion on Day 1 at pre-injection of PRP
• Diagnosis of chronic inflammatory disease (i.e. rheumatoid arthritis, reactive arthritis, psoriatic arthritis, chondromalacia, arthritis secondary to other inflammatory diseases)
• Untreated acute traumatic injury, presence of a symptomatic meniscal tear, valgus/varus deformity judged by the investigator to be clinically significant, in the index knee
• Recent (within 3-6 months) arthroscopy, open surgery, intra-articular steroid injections, intra-articular hyaluronic acid (HA) injections, systemic steroid treatment, malignancy
• Any serious, non-malignant, significant, acute, or chronic medical condition or active psychiatric illness that, in the investigator's opinion, could compromise patient safety, limit the patient's ability to complete the study, and/or compromise the objectives of the study.
• Recent (within 30 days) use of any investigational drug or device prior to screening

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Ortopedico Rizzoli

OTHER

Sponsor Role: collaborator

Istituto Clinico Humanitas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Istituto Clinico Humanitas

Rozzano, Milano, Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Berardo Di Matteo

Role: primary

reumatologia@humanitas.it

02 82241

Other Identifiers

GR-2019-12370692

Identifier Type: -

Identifier Source: org_study_id