Evidence map›Paper›PMID 26451369›Full record

Trial reportBioMed research international2015

Stem Cell Therapy for Corneal Epithelium Regeneration following Good Manufacturing and Clinical Procedures.

Beatriz E Ramírez, Ana Sánchez, José M Herreras, Itziar Fernández, Javier García-Sancho, Teresa Nieto-Miguel, Margarita Calonge

Registry-linked trialAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BioMed research international, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03884569 (Cultivated Limbal Epithelial Transplantation), which is not on this map. Cited by 42 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 5 pooled it
–field-weighted citation impact
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.

NCT03884569 not yet recruitingnot on this mapstarted 2025, after this paper: background citation

Cultivated Limbal Epithelial Transplantation (CLET) for Limbal Stem Cell Deficiency (LSCD): an Observational Study on Safety and Effectiveness

TypeobservationalSponsorInstituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBARan2025 to 2025Enrolled30ConditionsLimbal Stem-cell Deficiency
3 · Its place in the literature

Who cites it

42 citing papers in PubMed, 5 syntheses or guidelines pooled it.

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  8. Biomedical Application of MSCs in Corneal Regeneration and Repair.International journal of molecular sciences · 2025
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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

7 authors.

Beatriz E RamírezInstitute of Applied Ophthalmobiology (IOBA), University of Valladolid, Campus Universitario Miguel Delibes, Paseo de Belén 17, 47011 Valladolid, Spain.
Ana SánchezInstitute of Molecular Biology and Genetics (IBGM), University of Valladolid, Valladolid, Spain.
José M HerrerasInstitute of Applied Ophthalmobiology (IOBA), University of Valladolid, Campus Universitario Miguel Delibes, Paseo de Belén 17, 47011 Valladolid, Spain ; Networking Center for Biomedical Research in Bioengineering-Biomaterials and Nanomedicine (CIBER-BBN), Carlos III National Institute of Health, Spain.
Itziar FernándezInstitute of Applied Ophthalmobiology (IOBA), University of Valladolid, Campus Universitario Miguel Delibes, Paseo de Belén 17, 47011 Valladolid, Spain ; Networking Center for Biomedical Research in Bioengineering-Biomaterials and Nanomedicine (CIBER-BBN), Carlos III National Institute of Health, Spain.
Javier García-SanchoInstitute of Molecular Biology and Genetics (IBGM), University of Valladolid, Valladolid, Spain.
Teresa Nieto-MiguelInstitute of Applied Ophthalmobiology (IOBA), University of Valladolid, Campus Universitario Miguel Delibes, Paseo de Belén 17, 47011 Valladolid, Spain ; Networking Center for Biomedical Research in Bioengineering-Biomaterials and Nanomedicine (CIBER-BBN), Carlos III National Institute of Health, Spain.
Margarita CalongeInstitute of Applied Ophthalmobiology (IOBA), University of Valladolid, Campus Universitario Miguel Delibes, Paseo de Belén 17, 47011 Valladolid, Spain ; Networking Center for Biomedical Research in Bioengineering-Biomaterials and Nanomedicine (CIBER-BBN), Carlos III National Institute of Health, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate outcomes of cultivated limbal epithelial transplantation (CLET) for management of ocular surface failure due to limbal stem cell deficiency (LSCD).

designProspective, noncomparative, interventional case series and extensive comparison with recent similar studies.

participantsTwenty eyes with LSCD underwent CLET (11 autologous; 9 allogeneic) and were followed up for 3 years. Etiologies were divided into 3 prognostic categories: Group 1, chemical injuries (7 eyes); Group 2, immune-based inflammation (4 eyes); and Group 3, noninflammatory diseases (9 eyes). Intervention. Autologous and allogeneic limbal epithelial cells were cultivated on amniotic membranes and transplanted. Evaluations were based on clinical parameters, survival analysis, and in vivo confocal microscopy (IVCM). European Union Tissues/Cells Directive and good manufacturing procedures were followed.

main outcome measuresImproved clinical parameters, absence of epithelial defects, and improved central corneal epithelial phenotype.

resultsSuccess rate was 80% at 1-2 years and 75% at 3 years. Autografts and allografts had similar survival. Success rate was significantly lower in prognostic Group 1 (42.9%) than in Groups 2-3 (100% each). All clinical parameters improved substantially. By IVCM, 80% of cases improved in epithelial status.

conclusionsCLET improved corneal epithelium quality, with subsequent improvement in symptoms, quality of life, and vision. These results confirm that CLET is a valid therapy for ocular surface failure.

Indexed as

Practice Guidelines as TopicAdultAgedCorneal DiseasesEpithelium, CornealEuropean UnionFemaleHumansLimbus CorneaeMaleMiddle AgedRegenerationStem Cell Transplantation

Identifiers

PMID26451369
PMCPMC4588357

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Registered trials

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.