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The Effects of Allogeneic SLET

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ClinicalTrials.gov Identifier: NCT04021134
Recruitment Status : Recruiting
First Posted : July 16, 2019
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
To investigate the effect of allogeneic SLET and re-epithelialization after allogeneic SLET.

Condition or disease
Limbal Stem-cell Deficiency

Detailed Description:
Simple limbal epithelial transplantation (SLET) was introduced in 2012 by Sangwan and coworkers to overcome the issues mainly related to the cost of a GMP-certified product and ease of surgical manipulations that al- lows use of smaller pieces of limbus from the contralateral eye (thus avoiding iatrogenic problems). A completely epithelialized, avascular and stable corneal surface was achieved by 6 weeks and was maintained in all recipient eyes at a mean follow-up of 9.2 ± 1.9 months. Best corrected visual acuity improved from worse than 20/200 in all recipient eyes before surgery to 20/40 or better in four (66.6%) eyes. None of the donor eyes developed any complications.Basu et al. reported autologous SLET on a population of 125 patients which included 65 adults and 60 children suffering from unilateral LSCD. 76% (95/125) of eyes maintained a successful outcome at final follow-up without progressive conjunctivalization, development of persistent epithelial defect, infection, or need for repeat SLET. Survival probability of 80% in adults and 72% in children after 1 year. So far, most of the reports have been about autoSLET, that is, the limbal explants are obtained from the unaffected eye of the same recipient, avoiding immune reaction at the later stage. Also, they demonstrated SLET had promising result both in adults and children. A study by Iyer and coworkers used alloSLET in early stages after ocular chemical injury to achieve rapid epithelialization. Instead of taking the biopsy from the recipient's healthy eye, they took it from a cadaveric donor and performed the SLET. Epithelialization and improved best corrected visual acuity and corneal phenotype were achieved at early stages; however, 7 of 18 eyes had a gradual failure of the allograft, and 5 eyes underwent subsequent limbal autograft. Symblepheron formation involving one to two quadrants was recorded in 3 eyes (16.7%). Visual rehabilitative procedures in the chronic phase of chemical injury, in most instances after alloSLET in the acute stage, did not require any keratoplasties. Unfortunately, most diseases causing limbal deficiency, e.g., surface burns (alkali/ thermal), Stevens-Johnson syndrome, contact lens-related epitheliopathy, and ocular cicatricial pemphigoid, tend to affect both eyes of a patient. Autologous SLET may not be applicable in patients with bilateral eyes involvement. In this study, the effect of allogeneic SLET will be investigated.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Effects of Allogeneic Simple Limbal Epithelial Transplantation
Actual Study Start Date : July 5, 2019
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2025



Primary Outcome Measures :
  1. Numbers of patients with clinical success [ Time Frame: 6 months ]
    Clinical success is defined as a completely epithelized, avascular, stable corneal surface. Failure was defined as a recurrence of fibrovascular pannus encroaching on the central cornea, frequent epithelial breakdown or persistent epithelial defects. Focal recurrences of pannus not progressing to the central cornea were not considered as failures and were evaluated separately.


Secondary Outcome Measures :
  1. Best corrected visual acuity change [ Time Frame: 6 months ]
    Best corrected visual acuity (BCVA) was measured with Snellen chart preoperatively and at 6 months after the operation.



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Ages Eligible for Study:   10 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with limbal stem cell deficiency
Criteria

Inclusion Criteria:

  1. Age between 10 to 90 years old
  2. The lesion eye has at least grade 2 limbal stem cell deficiency
  3. The lesion eye has limbal stem cell deficiency causing recurrent corneal erosion and neovascularization ingrowth
  4. The symptoms last for at least 6 months and do not improve with medication

Exclusion Criteria:

  1. The symptoms improve spontaneously or with medication
  2. Someone who can not be examined regularly after the operation
  3. Poor prognosis
  4. Severe lagophthalmos or trichiasis that has not been corrected
  5. Ocular infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04021134


Contacts
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Contact: Wei-Li Chen, phD +886223123456 ext 65168 cwlntuh@gmail.com

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, Republic Of China, Taiwan, 10002
Contact: Wei-Li Chen, PhD    +886972651537    cwlntuh@gmail.com   
Department of Ophthalmology, National Taiwan University Hospital, Recruiting
Taipei, Taiwan, 100
Contact: Wei-Li Chen    +886-2-23123456 ext 5206    weilichen@ntu.edu.tw   
Contact: Hsiao-Sang Chu    +886-928-980736    b88401032@ntu.edu.tw   
Principal Investigator: Wei-Li Chen         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Study Chair: Wei-Li Chen, phD National Taiwan University Hospital

Publications:
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT04021134    
Other Study ID Numbers: 201904118RINB
First Posted: July 16, 2019    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD sharing in this study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No