Cultivated Limbal Epithelial Transplantation (CLET) for Limbal Stem Cell Deficiency (LSCD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Limbal Stem-cell Deficiency. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Cultivated Limbal Epithelial Transplantation (CLET) for Limbal Stem Cell Deficiency (LSCD): an Observational Study on Safety and Effectiveness
Overview
CLET is a published treatment for the management of corneal failure due to extensive LSCD. Due to our previous studies on this novel treatment, the regulatory agency of Spain "Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)" authorized our institution (IOBA-University of Valladolid) to perform this kind of therapy (CLET) in a case-by-case base following the Special Situation Medicines Policy Procedure in Spain. Upon approval of the permanent authorization patients will be included as specified by AEMPS.The objective of this study is to perform a protocolized treatment and follow up so that results can be reported to the scientific community.
Primary outcome measures
- Points of improvement in the Single Item Dry Eye Questionnaire (SIDEQ) [Time frame: 6 months]
- Points of improvement about the Ocular Surface Disease Index (OSDI) [Time frame: 6 months]
- Points of improvement in the National Eye Institute 25-item Visual Function Questionnaire (NEI-VFQ25) [Time frame: 6 months]
- Points of improvement in the Change in Dry Eye Symptoms Questionnaire (CDES-Q) [Time frame: 6 months]
- Percentage of improvement in corneal conjunctivalization [Time frame: 6 months]
- Complete absence of persistent epithelial defects [Time frame: 6 months]
Eligibility criteria
Total and/or severe LSCD of any etiology in one or both eyes.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 1 center
- IOBA — Valladolid
Publications
- Calonge M, Perez I, Galindo S, Nieto-Miguel T, Lopez-Paniagua M, Fernandez I, Alberca M, Garcia-Sancho J, Sanchez A, Herreras JM. A proof-of-concept clinical trial using mesenchymal stem cells for the treatment of corneal epithelial stem cell deficiency. Transl Res. 2019 Apr;206:18-40. doi: 10.1016/j.trsl.2018.11.003. Epub 2018 Nov 22. PMID 30578758
- Galindo S, Herreras JM, Lopez-Paniagua M, Rey E, de la Mata A, Plata-Cordero M, Calonge M, Nieto-Miguel T. Therapeutic Effect of Human Adipose Tissue-Derived Mesenchymal Stem Cells in Experimental Corneal Failure Due to Limbal Stem Cell Niche Damage. Stem Cells. 2017 Oct;35(10):2160-2174. doi: 10.1002/stem.2672. Epub 2017 Aug 10. PMID 28758321
- Lopez-Paniagua M, Nieto-Miguel T, de la Mata A, Galindo S, Herreras JM, Corrales RM, Calonge M. Successful Consecutive Expansion of Limbal Explants Using a Biosafe Culture Medium under Feeder Layer-Free Conditions. Curr Eye Res. 2017 May;42(5):685-695. doi: 10.1080/02713683.2016.1250278. Epub 2016 Dec 2. PMID 27911610
- Lopez-Paniagua M, Nieto-Miguel T, de la Mata A, Dziasko M, Galindo S, Rey E, Herreras JM, Corrales RM, Daniels JT, Calonge M. Comparison of functional limbal epithelial stem cell isolation methods. Exp Eye Res. 2016 May;146:83-94. doi: 10.1016/j.exer.2015.12.002. Epub 2015 Dec 17. PMID 26704459
- Ramirez BE, Sanchez A, Herreras JM, Fernandez I, Garcia-Sancho J, Nieto-Miguel T, Calonge M. Stem Cell Therapy for Corneal Epithelium Regeneration following Good Manufacturing and Clinical Procedures. Biomed Res Int. 2015;2015:408495. doi: 10.1155/2015/408495. Epub 2015 Sep 16. PMID 26451369
- Ramirez BE, Victoria DA, Murillo GM, Herreras JM, Calonge M. In vivo confocal microscopy assessment of the corneoscleral limbal stem cell niche before and after biopsy for cultivated limbal epithelial transplantation to restore corneal epithelium. Histol Histopathol. 2015 Feb;30(2):183-92. doi: 10.14670/HH-30.183. Epub 2014 Jul 30. PMID 25075515
- de la Mata A, Nieto-Miguel T, Lopez-Paniagua M, Galindo S, Aguilar MR, Garcia-Fernandez L, Gonzalo S, Vazquez B, Roman JS, Corrales RM, Calonge M. Chitosan-gelatin biopolymers as carrier substrata for limbal epithelial stem cells. J Mater Sci Mater Med. 2013 Dec;24(12):2819-29. doi: 10.1007/s10856-013-5013-3. Epub 2013 Jul 28. PMID 23892486
- Nieto-Miguel T, Galindo S, Reinoso R, Corell A, Martino M, Perez-Simon JA, Calonge M. In vitro simulation of corneal epithelium microenvironment induces a corneal epithelial-like cell phenotype from human adipose tissue mesenchymal stem cells. Curr Eye Res. 2013 Sep;38(9):933-44. doi: 10.3109/02713683.2013.802809. Epub 2013 Jun 14. PMID 23767776
Identifiers
NCT: NCT03884569 · IOBA201901