RT Journal Article
T1 Successful development and clinical translation of a novel anterior lamellar artificial cornea.
A1 Rico-Sanchez, Laura
A1 Garzon, Ingrid
A1 Gonzalez-Andrades, Miguel
A1 Ruiz-Garcia, Antonio
A1 Punzano, Miriam
A1 Lizana-Moreno, Antonio
A1 Muñoz-Avila, Jose Ignacio
A1 Sanchez-Quevedo, Maria Del Carmen
A1 Martinez-Atienza, Juliana
A1 Lopez-Navas, Luis
A1 Sanchez-Pernaute, Rosario
A1 Oruezabal, Roke Iñaki
A1 Medialdea, Santiago
A1 Gonzalez-Gallardo, Maria Del Carmen
A1 Carmona, Gloria
A1 Sanbonmatsu-Gamez, Sara
A1 Perez, Matias
A1 Jimenez, Pilar
A1 Cuende, Natividad
A1 Campos, Antonio
A1 Alaminos, Miguel
K1 Advanced therapy medicinal products (ATMPs)
K1 Clinical translation
K1 Cornea
K1 Preclinical research
K1 Regulatory issues
K1 Tissue engineering
K1 Tissue-engineered anterior human cornea (TEAHC)
AB 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.
PB Wiley
YR 2019
FD 2019-07-27
LK http://hdl.handle.net/10668/14357
UL http://hdl.handle.net/10668/14357
LA en
NO Rico-Sánchez L, Garzón I, González-Andrades M, Ruíz-García A, Punzano M, Lizana-Moreno A, et al. Successful development and clinical translation of a novel anterior lamellar artificial cornea. J Tissue Eng Regen Med. 2019 Dec;13(12):2142-2154
DS RISalud
RD Apr 7, 2025