The Effects of Allogeneic SLET

July 16, 2019 updated by: National Taiwan University Hospital

The Effects of Allogeneic Simple Limbal Epithelial Transplantation

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Recruiting
        • Department of Ophthalmology, National Taiwan University Hospital,
        • Contact:
        • Contact:
        • Principal Investigator:
          • Wei-Li Chen
    • Taiwan, Republic Of China
      • Taipei, Taiwan, Republic Of China, Taiwan, 10002
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

10 years to 90 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with limbal stem cell deficiency

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 5, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 3, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 18, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201904118RINB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD sharing in this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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