@article {1460379,
	title = {Successful development and clinical translation of a novel anterior lamellar artificial cornea},
	journal = {J Tissue Eng Regen Med},
	volume = {13},
	number = {12},
	year = {2019},
	month = {2019 Dec},
	pages = {2142-2154},
	abstract = {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.},
	issn = {1932-7005},
	doi = {10.1002/term.2951},
	author = {Rico-S{\'a}nchez, Laura and Garz{\'o}n, Ingrid and Gonz{\'a}lez-Andrades, Miguel and Ru{\'\i}z-Garc{\'\i}a, Antonio and Punzano, Miriam and Lizana-Moreno, Antonio and Mu{\~n}oz-{\'A}vila, Jose Ignacio and S{\'a}nchez-Quevedo, Maria Del Carmen and Mart{\'\i}nez-Atienza, Juliana and Lopez-Navas, Luis and Sanchez-Pernaute, Rosario and Oruezabal, Roke I{\~n}aki and Medialdea, Santiago and Gonzalez-Gallardo, Maria Del Carmen and Carmona, Gloria and Sanbonmatsu-G{\'a}mez, Sara and Perez, Mat{\'\i}as and Jimenez, Pilar and Cuende, Natividad and Campos, Antonio and Alaminos, Miguel}
}
