Profiling knee osteoarthritis patients to predict response to regenerative treatment
Immuno-based Profiling of knEe OA Patients to Predict reSponse to Regenerative Treatment
This study is trying to see if certain characteristics of people with knee osteoarthritis can help predict how well they will respond to platelet-rich plasma injections as a treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 105 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | Istituto Clinico Humanitas Academic / other |
| Locations | 1 site (Rozzano, Milano) |
| Trial ID | NCT06384040 on ClinicalTrials.gov |
What this trial studies
This observational study aims to profile patients with knee osteoarthritis (OA) to predict their response to platelet-rich plasma (PRP) injections, a minimally invasive treatment option. By analyzing clinical data, imaging, and specific biomarkers related to inflammatory and antioxidant pathways, the study seeks to identify unique profiles that can guide personalized treatment approaches. The goal is to enhance the effectiveness of immunomodulatory and regenerative therapies for knee OA, addressing the current lack of predictive biomarkers in this condition.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 40 to 75 with grade 2-3 knee osteoarthritis who have failed at least one conservative therapy.
Not a fit: Patients with active infections, chronic inflammatory diseases, or recent knee surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and personalized treatment options for patients with knee osteoarthritis.
How similar studies have performed: While the approach of using PRP injections is established, the specific profiling for predictive response in knee OA is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rozzano, Milano
- Istituto Clinico Humanitas — Rozzano, Milano, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.