Extracellular Vesicles in Fibrin Gel for Cartilage Repair

Last updated: November 27, 2024
Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Overall Status: Active - Recruiting

Phase

N/A

Condition

Arthritis And Arthritic Pain

Treatment

N/A

Clinical Study ID

NCT06713902
GelVex
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • males and females ≥ 18

  • patients undergoing plastic surgery procedures;

  • patients undergoing elective joint surgery with a diagnosis of knee or hiposteoarthritis (any Kellgren-Lawrence grade);

  • patients undergoing regenerative medicine treatments with PRP with a diagnosis ofknee or hip osteoarthritis (any Kellgren-Lawrence grade;

  • signed Informed Consent for the study

Exclusion

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

Study Design

Total Participants: 51
Study Start date:
October 29, 2024
Estimated Completion Date:
August 30, 2026

Connect with a study center

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

    Milano, MI 20157
    Italy

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.