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

Osteoarthritis, Knee Clinical Trial

— IMPRESA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06384040
• Other study ID #: GR-2019-12370692
• Status: Recruiting
• Start date: November 1, 2021
• Est. completion date: October 30, 2024

Study information

• Verified date: April 2024
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: October 30, 2024
• Est. primary completion date: September 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
Italy	Istituto Clinico Humanitas	Rozzano	Milano

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas	Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	knee OA patients focusing on changes in Wnt and IL1-ß signalling and PTX3 expression	We will collect peripheral blood (PB) samples and cellular and molecular components in these samples will be characterized by measuring gene expression and protein levels of soluble factors involved in inflammatory pathways, with specific attention to Wnt and IL1 signaling pathways, and PTX3, and by performing a complete immunophenotype. We will use computational clustering approaches applied to single cell FACS data (Phenograph, FlowSOM, or similar) to identify phenotypic subsets in an unbiased way.	18 months
Secondary	To assess the overall oxidative status and antioxidant capacity of the enrolled OA patients and its possible prognostic role with respect to response to PRP treatment	We will define the overall oxidative status in the patients at baseline, by measuring a set of parameters related to enzymatic and non-enzymatic antioxidant systems, comprising the total antioxidant capacity, total glutathione, catalase activity, advanced glycation end products, HNE adducts, vitamin E and C, in the serum and SF, when available.	36 months