Cultivated Limbal Epithelial Transplantation (CLET) for Limbal Stem Cell Deficiency (LSCD)

Limbal Stem-cell Deficiency Clinical Trial

— CLET-4-LSCD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03884569
• Other study ID #: IOBA201901
• Status: Not yet recruiting
• Start date: April 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2022
• Source: Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
• Contact: Margarita Calonge, MD, PhD
• Phone: 34983184750
• Email: calonge[@]ioba.med.uva.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older
• Eligibility: Total and/or severe LSCD of any etiology in one or both eyes.

Related Conditions & MeSH terms

• Limbal Stem-cell Deficiency

Locations

Country	Name	City	State
Spain	IOBA	Valladolid

Sponsors (4)

Lead Sponsor	Collaborator
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA	Citospin, Red de Terapia Celular, University of Valladolid

Country where clinical trial is conducted

Spain, 

References & Publications (11)

Calonge M, Pérez I, Galindo S, Nieto-Miguel T, López-Paniagua M, Fernández I, Alberca M, García-Sancho J, Sánchez A, Herreras JM. A proof-of-concept clinical trial using mesenchymal stem cells for the treatment of corneal epithelial stem cell deficiency. — View Citation

de la Mata A, Mateos-Timoneda MA, Nieto-Miguel T, Galindo S, López-Paniagua M, Planell JA, Engel E, Calonge M. Poly-l/dl-lactic acid films functionalized with collagen IV as carrier substrata for corneal epithelial stem cells. Colloids Surf B Biointerface — View Citation

de la Mata A, Nieto-Miguel T, López-Paniagua M, Galindo S, Aguilar MR, García-Fernández L, Gonzalo S, Vázquez B, Román JS, Corrales RM, Calonge M. Chitosan-gelatin biopolymers as carrier substrata for limbal epithelial stem cells. J Mater Sci Mater Med. 2 — View Citation

Galindo S, Herreras JM, López-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 — View Citation

López-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 — View Citation

López-Paniagua M, Nieto-Miguel T, de la Mata A, Galindo S, Herreras JM, Corrales RM, Calonge M. Consecutive expansion of limbal epithelial stem cells from a single limbal biopsy. Curr Eye Res. 2013 May;38(5):537-49. doi: 10.3109/02713683.2013.767350. Epub — View Citation

López-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. do — View Citation

Nieto-Miguel T, Calonge M, de la Mata A, López-Paniagua M, Galindo S, de la Paz MF, Corrales RM. A comparison of stem cell-related gene expression in the progenitor-rich limbal epithelium and the differentiating central corneal epithelium. Mol Vis. 2011;1 — View Citation

Nieto-Miguel T, Galindo S, Reinoso R, Corell A, Martino M, Pérez-Simón 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 Re — View Citation

Ramírez BE, Sánchez A, Herreras JM, Fernández I, García-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: 10.1155/2015/40 — View Citation

Ramírez 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 — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Points of improvement in the Single Item Dry Eye Questionnaire (SIDEQ)	The SIDEQ gives a 0-4 score about the presence of dryness, foreign body sensation, burning/stinging, pain, itching, sensitivity to light, and blurred vision, where higher scores indicate higher intensity of the symptom (maximun score: 28). One of the primary outcomes for this work is the improvement in any of the four questionnaires shown here.	6 months
Primary	Points of improvement about the Ocular Surface Disease Index (OSDI)	The OSDI evaluates ocular surface symptoms with 12 questions, and scores >12 indicate abnormal symptomatology, and >32 means severe symptoms (maximum score 100). One of the primary outcomes for this work is the improvement in any of the four questionnaires shown here.	6 months
Primary	Points of improvement in the National Eye Institute 25-item Visual Function Questionnaire (NEI-VFQ25)	The visual function-related aspects of the quality of life were evaluated with the NEI-VFQ25, where higher scores on a 0 to 100 scale indicate better function. One of the primary outcomes for this work is the improvement in any of the four questionnaires shown here.	6 months
Primary	Points of improvement in the Change in Dry Eye Symptoms Questionnaire (CDES-Q)	The CDES-Q evaluates ocular surface symptoms with two questions, CDES-Q1 and CDES-Q2. CDES-Q1 evaluates the change in symptoms occured since the previous examination (same, better or worse). CDES-Q2 evaluates the magnitude of the change in a scale from 0 to 10, where 0 means "slightly better/worse" and 10 means "extremely better/worse". One of the primary outcomes for this work is the improvement in any of the four questionnaires shown here.	6 months
Primary	Percentage of improvement in corneal conjunctivalization	Percentage of corneal area with conjunctivalization (superficial opacity and/or superficial neovascularization) will be measured.	6 months
Primary	Complete absence of persistent epithelial defects	Corneal fluorescein staining has to rule out epithelial breakdown	6 months