Challenges in the development of a reference standard and potency assay for the clinical production of RAFT tissue equivalents for the cornea.
Regen Med
; 9(2): 167-77, 2014 Mar.
Article
en En
| MEDLINE
| ID: mdl-24750058
AIM: To develop a reference standard and potency assay for Real Architecture For 3D Tissues (RAFT) tissue equivalents intended for use in limbal epithelial stem cell (LESC) therapy for the cornea. METHODS: RAFT, a cell-seeded plastic compressed collagen construct with LESCs cultured on the surface, was manufactured with the goal of achieving GMP compliance. RAFTs were tested for reproducibility of manufacture (reference standard) and subsequently wounded and monitored for re-epithelialization (potency assay). RESULTS: RAFT tissue equivalents produced with cells from different biological donors were capable of supporting multilayered epithelium in culture. The potency assay demonstrated re-epithelialization following wounding, indicating the potential efficacy of RAFT constructs. CONCLUSION: We have presented our attempts at creating a reference standard and potency assay for the clinical manufacture of RAFT for the treatment of LESC deficiency. However, it remains challenging for adult stem cell therapies (including LESC therapy) to fully meet regulatory requirements when dealing with a limited source of autologous cells with inherent biological variation between donors.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Bioensayo
/
Córnea
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Ingeniería de Tejidos
Límite:
Animals
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Humans
Idioma:
En
Revista:
Regen Med
Año:
2014
Tipo del documento:
Article
Pais de publicación:
Reino Unido