Using extracellular vesicles in fibrin gel to repair cartilage
Fibrin Gel Loaded with Extracellular Vesicles for the Treatment of Cartilage Lesions in the Joints - GelVex Study
This study is testing a new way to help repair cartilage using a special gel made from blood and tiny particles from stem cells to see if it works better for orthopedic patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 51 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio Academic / other |
| Locations | 1 site (Milan, MI) |
| Trial ID | NCT06713902 on ClinicalTrials.gov |
What this trial studies
This project aims to create and analyze a fibrin gel derived from platelet-rich plasma (PRP) that is loaded with extracellular vesicles from mesenchymal stromal cells (MSC). The goal is to combine the beneficial effects of PRP growth factors with the cartilage-stimulating properties of MSC-EVs to enhance cartilage repair. This innovative approach seeks to provide orthopedic patients with a more effective treatment option that can be easily integrated into standard clinical practices.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 undergoing elective joint surgery or regenerative treatments for knee or hip osteoarthritis.
Not a fit: Patients with positive virological tests or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve cartilage repair in patients with joint diseases.
How similar studies have performed: While this approach is innovative, similar studies utilizing MSC-EVs for cartilage repair have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * males and females ≥ 18 * patients undergoing plastic surgery procedures; * patients undergoing elective joint surgery with a diagnosis of knee or hip osteoarthritis (any Kellgren-Lawrence grade); * patients undergoing regenerative medicine treatments with PRP with a diagnosis of knee or hip osteoarthritis (any Kellgren-Lawrence grade; * signed Informed Consent for the study Exclusion Criteria: * Positive virological test (HIV, HCV, HBV, TPHA) * Pregnancy or breastfeeding by self-declaration * Other conditions that, at the discretion of the investigator or the physician
Where this trial is running
Milan, MI
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio — Milan, Mi, Italy (Recruiting)
Study contacts
- Study coordinator: Giuseppe Peretti
- Email: enrico.ragni@grupposandonato.it
- Phone: +390283502254
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.