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NCT06384040 | RECRUITING | Osteoarthritis, Knee

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

Humanitas Clinical Institute

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.

Condition or disease

Osteoarthritis, Knee

Intervention/treatment

platelet-rich plasma knee injection

Study Type : OBSERVATIONAL
Estimated Enrollment : 105 participants
Official Title : Immuno-based Profiling of knEe OA Patients to Predict reSponse to Regenerative Treatment
Actual Study Start Date : 2021-11-01
Estimated Primary Completion Date : 2023-09-04
Estimated Study Completion Date : 2024-10-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Immuno-based Profiling of knEe OA Patients to Predict reSponse to Regenerative Treatment

Location Details

NCT06384040

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Locations

RECRUITING

Italy, Milano

Humanitas Clinical Institute

Rozzano, Milano, Italy, 20089