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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Istituto Clinico Humanitas
RECRUITING
Rozzano
Time Frame
Start Date: 2021-11-01
Estimated Completion Date: 2024-10-30
Participants
Target number of participants: 105
Treatments
PRP responder
response to treatment will be established in the presence of \>40% improvement of pain and/or motility
PRP non responder
response to treatment will be established in the presence of \<40% improvement of pain and/or motility
Related Therapeutic Areas
Sponsors
Collaborators: Istituto Ortopedico Rizzoli
Leads: Istituto Clinico Humanitas

This content was sourced from clinicaltrials.gov

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