Extracellular Vesicles in Fibrin Gel for Cartilage Repair

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.

Recruiting

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Key information

Conditions

Joint Disease Joint Diseases Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Milan, MI, 20157, Italy

Location status: Recruiting

Location contact

Direzione Scientifica

CONTACT

[email protected]

00390283502224

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Time frame: 2 years

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Giuseppe Peretti

CONTACT

[email protected]

+390283502254

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Fibrin Gel Loaded with Extracellular Vesicles for the Treatment of Cartilage Lesions in the Joints - GelVex Study

Acronym: GelVex

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Dec 3, 2024
Registry last updated: Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed