Successful development and clinical translation of a novel anterior lamellar artificial cornea
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AuthorRico‐Sánchez, Laura; Garzón Bello, Ingrid Johanna; González Andrades, Miguel; Ruíz‐García, Antonio; Punzano, Miriam; Lizana Moreno, Antonio Manuel; Muñoz Ávila, José Ignacio; Sánchez Quevedo, María Del Carmen; Martínez‐Atienza, Juliana; López‐Navas, Luis; Sánchez‐Pernaute, Rosario; Oruezabal, Roke Iñaki; Medialdea Marcos, Santiago; González-Gallardo, María del Carmen; Carmona, Gloria; Sanbonmatsu-Gámez, Sara; Pérez, Matías; Jiménez, Pilar; Cuende Melero, Natividad; Campos Muñoz, Antonio Jesús; Alaminos Mingorance, Miguel
Advanced therapy medicinal products (ATMPs)Clinical translationCorneaPreclinical researchRegulatory issuesTissue‐engineered anterior human cornea (TEAHC)Tissue engineering
Rico‐Sánchez L, Garzón I, González‐ Andrades M, et al. Successful development and clinical translation of a novel anterior lamellar artificial cornea. J Tissue Eng Regen Med. 2019;13:2142–2154. [https://doi.org/10.1002/term.2951]
SponsorshipThis study was supported by the Spanish National Plan for Scientific and Technical Research and Innovation (I + D + I) from the Spanish Ministry of Economy and Competitiveness (Carlos III Institute of Health), grants FIS PI14/0955 and FIS PI17/0391 (both cofinanced by ERDF‐FEDER, European Union); by the Spanish Ministry of Health, Social Policy and Equity, grant EC10‐285; and by preclinical research funds from the Regional Ministry of Health through the Andalusian Initiative for Advanced Therapies.
Blindness due to corneal diseases is a common pathology affecting up to 23 million individuals worldwide. The tissue‐engineered anterior human cornea, which is currently being tested in a Phase I/II clinical trial to treat severe corneal trophic ulcers with preliminary good feasibility and safety results. This bioartificial cornea is based on a nanostructured fibrin–agarose biomaterial containing human allogeneic stromal keratocytes and cornea epithelial cells, mimicking the human native anterior cornea in terms of optical, mechanical, and biological behavior. This product is manufactured as a clinical‐grade tissue engineering product, fulfilling European requirements and regulations. The clinical translation process included several phases: an initial in vitro and in vivo preclinical research plan, including preclinical advice from the Spanish Medicines Agency followed by additional preclinical development, the adaptation of the biofabrication protocols to a good manufacturing practice manufacturing process, including all quality controls required, and the design of an advanced therapy clinical trial. The experimental development and successful translation of advanced therapy medicinal products for clinical application has to overcome many obstacles, especially when undertaken by academia or SMEs. We expect that our experience and research strategy may help future researchers to efficiently transfer their preclinical results into the clinical settings.