NCT06384040

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 105 (estimated)
• Sponsor: Istituto Clinico Humanitas · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	platelet-rich plasma knee injection	platelet-rich plasma knee injection and observation for 12 months for definition of responder and non responder

Timeline

• Start date: 2021-11-01
• Primary completion: 2023-09-04
• Completion: 2024-10-30
• First posted: 2024-04-25
• Last updated: 2024-04-30

Locations

1 site across 1 country: Italy