Clinical-grade extracellular vesicles derived from umbilical cord mesenchymal stromal cells: preclinical development and first-in-human intra-articular validation as therapeutics for knee osteoarthritis

Osteoarthritis (OA) is a joint disease characterized by articular cartilage degradation. Persistent low-grade inflammation defines OA pathogenesis, with crucial involvement of pro-inflammatory M1-like macrophages. While mesenchymal stromal cells (MSC) and their small extracellular vesicles (sEV) hold promise for OA treatment, achieving consistent clinical-grade sEV products remains a significant challenge. This study aims to develop fully characterized, reproducible, clinical-grade batches of sEV derived from umbilical cord (UC)-MSC for the treatment of OA while assessing its efficacy and safety. Initially, a standardized, research-grade manufacturing protocol was established to ensure consistent sEV…

• AN
  Agencia Nacional de Investigación e Innovación

  Awards: 2022-21220091, 1211353
• CD
  Corporación de Fomento de la Producción

  Award: 13CTI-21522
• AN
  Agenția Națională pentru Cercetare și Dezvoltare
• UD
  Universidad de Chile
• AN
  Agencia Nacional de Investigación y Desarrollo

  Awards: 1211376, EQM150010, ID21I10194, FB210024, ID23I10325, 1211353
• C
  CHIST-ERA