title: A journey from basic stem cell discovery to clinical application: the case of adventitial progenitor cells.
abstract: Ischemia is a leading cause of death in the western world. Regenerative medicine aims to improve healing of ischemic injury by complementing pharmacologic/interventional treatments. Navigating regenerative therapies from 'bench-to-bedside' is a multistep time-consuming process, balancing cell expansion, purity, safety and efficacy while complying with regulatory guidelines. Studies started in academic laboratories unused to long-term planning often fail because of poor strategy design, lack of contingency plans or funding. We provide a strategic insight into our translation of saphenous vein-derived adventitial progenitor cells into a clinical grade product to treat angina. We discuss discovery phases, introduction of standard operating procedures and upgrade to clinical standards. We also examine contractual aspects of transferring to GMP-accredited facilities for clinical production and unexpected hurdles.
authors.affiliation: Bristol Heart Institute, Bristol Royal Infirmary, Level 7, Bristol, BS2 8HW, UK.
authors.forename: Helen L
authors.initials: HL
authors.lastname: Spencer
authors.forename: Sadie C
authors.initials: SC
authors.lastname: Slater
authors.forename: Jonathan
authors.initials: J
authors.lastname: Rowlinson
authors.forename: Tom
authors.initials: T
authors.lastname: Morgan
authors.forename: Lucy A
authors.initials: LA
authors.lastname: Culliford
authors.forename: Martin
authors.initials: M
authors.lastname: Guttridge
authors.forename: Costanza
authors.initials: C
authors.lastname: Emanueli
authors.forename: Gianni
authors.initials: G
authors.lastname: Angelini
authors.forename: Paolo
authors.initials: P
authors.lastname: Madeddu
mesh_terms: D063194:Adventitia / Q000166:cytology*; D000818:Animals; D002318:Cardiovascular Diseases / Q000628:therapy; D004195:Disease Models, Animal; D006801:Humans; D033581:Stem Cell Transplantation / Q000009:adverse effects; D013234:Stem Cells / Q000166:cytology*; D057170:Translational Research, Biomedical
keywords: GMP; cell therapy; ischemia; pericytes; regenerative medicine; stem cell