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

Istituto Clinico Humanitas

Status

Enrolling

Conditions

Osteoarthritis, Knee

Treatments

Procedure: platelet-rich plasma knee injection

Study type

Observational

Funder types

Other

Identifiers

NCT06384040

GR-2019-12370692

Details and patient eligibility

About

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.

Enrollment

105 estimated patients

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

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