Extracellular Vesicles in Fibrin Gel for Cartilage Repair

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio51 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Joint Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Outcomes

Primary Outcomes

Confirm the incorporation rate of extracellular vesicles (EV) into platelet-rich plasma (PRP) following the formation of fibrin gel

To implement the preliminary data obtained by the PI in the development of a protocol to achieve efficient incorporation of mesenchymal stem cell-derived extracellular vesicles into platelet-rich plasma-derived fibrin gels and characterize their release. MSC-EVs will be embedded in fibrin gel using PRP provided by patients enrolled in the study that is activated to obtain the solid form. To monitor the incorporation and release of EVs from the PRP-gel, EVs will be labeled with a fluorescent marker to allow their subsequent detection by cytometry or imaging methods. The ability of the released EVs to be incorporated into human chondrocytes and penetrate cartilage will be tested using three in vitro models: i) flow cytometry in a 2D culture model; ii) a 3D microfluidic model; iii) a Quantitative Imaging with cartilage explants. Biological activity will be tested on pathological chondrocytes.

Time frame: 2 years