Extracellular Vesicles in Fibrin Gel for Cartilage Repair (GelVex)

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Status: Enrolling

Conditions: Joint Disease

Study type: Observational

Funder types: Other

Identifiers

NCT06713902

GelVex

Details and patient eligibility

About

This project aims to produce and study in vitro/ex vivo a platelet rich plasma (PRP)-derived fibrin gel loaded with mesenchymal stromal cells (MSC)-extracellular vesicles (EVs), to combine the positive results on cartilage growth of PRP growth factors and the hyaline cartilage stimulating activity of MSC-EVs. Therefore, the project goal is to provide an advanced option for orthopedic patients with an innovative evolution of a gold standard procedure, making it easy to translate into daily clinical practice for physicians, healthcare professionals and patients.

Enrollment: 51 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

51 participants in 1 patient group

Fifty-one m/f patients matching the inclusion and exclusion criteria

Description:

Six patients undergoing plastic surgery procedures for the removal of adipose tissue from which waste material (adipose tissue) will be taken to obtain MSCs for EVs production. Five patients undergoing hip or knee joint replacement surgery from which waste material (osteo-cartilaginous material) will be taken to obtain chondrocytes for functional tests. Forty patients undergoing regenerative medicine treatments with PRP from which a waste aliquot (obtained during PRP preparation) will be taken to obtain plasma for fibrin gel production.