Evidence map›Paper›PMID 31373143›Full record

ArticleJournal of tissue engineering and regenerative medicine2019

Successful development and clinical translation of a novel anterior lamellar artificial cornea.

Laura Rico-Sánchez, Ingrid Garzón, Miguel González-Andrades, Antonio Ruíz-García, Miriam Punzano, Antonio Lizana-Moreno, Jose Ignacio Muñoz-Ávila, Maria Del Carmen Sánchez-Quevedo, Juliana Martínez-Atienza, Luis Lopez-Navas and 11 more

Open access · hybridAbstract read
In one paragraph

Article in Journal of tissue engineering and regenerative medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 1 pooled it
6.7field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 1 synthesis or guideline pooled it, 64 citations in OpenAlex.

  1. Pooled it
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  11. The origin of human epithelial tissue.Histology and histopathology · 2023
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors at 5 institutions in 2 countries.

Laura Rico-SánchezAndalusian Initiative for Advanced Therapies, Progress and Health Andalusian Public Foundation, Sevilla, Spain.
Ingrid GarzónTissue Engineering Group, Department of Histology, University of Granada, Granada, Spain.
Miguel González-AndradesUnidad de Oftalmología, Hospital Universitario San Cecilio, Granada, Spain.
Antonio Ruíz-GarcíaUnidad de Producción Celular e Ingeniería Tisular, Hospital Universitario Virgen de las Nieves, Granada, Spain.
Miriam PunzanoUnidad de Producción Celular e Ingeniería Tisular, Hospital Universitario Virgen de las Nieves, Granada, Spain.
Antonio Lizana-MorenoUnidad de Producción Celular e Ingeniería Tisular, Hospital Universitario Virgen de las Nieves, Granada, Spain.
Jose Ignacio Muñoz-ÁvilaTissue Engineering Group, Department of Histology, University of Granada, Granada, Spain.
Maria Del Carmen Sánchez-QuevedoTissue Engineering Group, Department of Histology, University of Granada, Granada, Spain.
Juliana Martínez-AtienzaAndalusian Initiative for Advanced Therapies, Progress and Health Andalusian Public Foundation, Sevilla, Spain.ORCID 0000-0002-0391-5180
Luis Lopez-NavasAndalusian Initiative for Advanced Therapies, Progress and Health Andalusian Public Foundation, Sevilla, Spain.
Rosario Sanchez-PernauteAndalusian Initiative for Advanced Therapies, Progress and Health Andalusian Public Foundation, Sevilla, Spain.
Roke Iñaki OruezabalAndalusian Initiative for Advanced Therapies, Progress and Health Andalusian Public Foundation, Sevilla, Spain.
Santiago MedialdeaUnidad de Oftalmología, Hospital Universitario Virgen de las Nieves, Granada, Spain.
Maria Del Carmen Gonzalez-GallardoUnidad de Oftalmología, Hospital Universitario San Cecilio, Granada, Spain.
Gloria CarmonaAndalusian Initiative for Advanced Therapies, Progress and Health Andalusian Public Foundation, Sevilla, Spain.
Sara Sanbonmatsu-GámezServicio de Microbiología, Hospital Universitario Virgen de las Nieves, Granada, Spain.
Matías PerezServicio de Análisis Clínicos e Inmunología, UGC de Laboratorio Clínico, Hospital Universitario Virgen de las Nieves, Granada, Spain.
Pilar JimenezServicio de Análisis Clínicos e Inmunología, UGC de Laboratorio Clínico, Hospital Universitario Virgen de las Nieves, Granada, Spain.
Natividad CuendeAndalusian Initiative for Advanced Therapies, Progress and Health Andalusian Public Foundation, Sevilla, Spain.
Antonio CamposTissue Engineering Group, Department of Histology, University of Granada, Granada, Spain.
Miguel AlaminosTissue Engineering Group, Department of Histology, University of Granada, Granada, Spain.
Andalusian Health Service · ESUniversidad de Granada · ESInstituto de Investigación Biosanitaria de Granada · ESHospital Universitario Virgen de las Nieves · ESMassachusetts Eye and Ear Infirmary · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Corneal DiseasesEpithelium, CornealTissue EngineeringAnimalsBiocompatible MaterialsHumansRabbitsBiocompatible Materialsadvanced therapy medicinal products (ATMPs)clinical translationcorneapreclinical researchregulatory issuestissue-engineered anterior human cornea (TEAHC)tissue engineering

Identifiers

PMID31373143
PMCPMC6973105
OpenAlexW2964392686

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.