Limbal Stem-cell DeficiencyNCT04021134
The Effects of Allogeneic SLET
An observational study of Limbal Stem-cell Deficiency, run by National Taiwan University Hospital at 2 sites in Taiwan.
Trial summary
To investigate the effect of allogeneic SLET and re-epithelialization after allogeneic SLET. Read more about this study
- Who is it for?
- Ages 10 to 90 years
- Conditions the study is for
- Limbal Stem-cell Deficiency
- How many people
- 30 participants
- Where
- 2 sitesTaiwan
- Study dates
- 5 Jul 2019to 1 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with limbal stem cell deficiency
Who may be able to join
- Age between 10 to 90 years old
- The lesion eye has at least grade 2 limbal stem cell deficiency
- The lesion eye has limbal stem cell deficiency causing recurrent corneal erosion and neovascularization ingrowth
- The symptoms last for at least 6 months and do not improve with medication
Who cannot join
- The symptoms improve spontaneously or with medication
- Someone who can not be examined regularly after the operation
- Poor prognosis
- Severe lagophthalmos or trichiasis that has not been corrected
- Ocular infection
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taiwan, Republic of China, 10002
Wei-Li Chen, PhD, +886972651537, cwlntuh@gmail.com
- Recruiting
Department of Ophthalmology, National Taiwan University Hospital,
Taipei, 100
Wei-Li Chen, +886-2-23123456 ext. 5206, weilichen@ntu.edu.tw
Hsiao-Sang Chu, +886-928-980736, b88401032@ntu.edu.tw
About this study
Official title: The Effects of Allogeneic Simple Limbal Epithelial Transplantation
To investigate the effect of allogeneic SLET and re-epithelialization after allogeneic SLET.
Read the 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.
- Conditions
- Limbal Stem-cell Deficiency
- Medical subject headings
- Limbal Stem Cell Deficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of patients with clinical success
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.
Measured: 6 months
Secondary outcomes (1)
Best corrected visual acuity change
Best corrected visual acuity (BCVA) was measured with Snellen chart preoperatively and at 6 months after the operation.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start5 Jul 2019
- Primary completion1 Jul 2020 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Limbal Stem-cell DeficiencyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei-Li Chen, phD, Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04021134
- Sponsor's protocol ID
- 201904118RINB
- Status last verified
- Jun 2019
- First submitted
- 3 Jul 2019
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD sharing in this study
Publications
Borroni D, Wowra B, Romano V, Boyadzhieva M, Ponzin D, Ferrari S, Ahmad S, Parekh M. Simple limbal epithelial transplantation: a review on current approach and future directions. Surv Ophthalmol. 2018 Nov-Dec;63(6):869-874. doi: 10.1016/j.survophthal.2018.05.003. Epub 2018 May 22.
PubMed 29800578Iyer G, Srinivasan B, Agarwal S, Tarigopula A. Outcome of allo simple limbal epithelial transplantation (alloSLET) in the early stage of ocular chemical injury. Br J Ophthalmol. 2017 Jun;101(6):828-833. doi: 10.1136/bjophthalmol-2016-309045. Epub 2016 Oct 8.
PubMed 28407620
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Allogeneic Simple Limbal Epithelial Transplantation
- ClinicalTrials.gov ID
- NCT04021134
- Acronym / sponsor ID
- 201904118RINB
- Conditions
- Limbal Stem-cell Deficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 5 Jul 2019 (actual)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 16 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the effect of allogeneic SLET and re-epithelialization after allogeneic SLET.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with limbal stem cell deficiency
Key inclusion criteria (4 listed)
- Age between 10 to 90 years old
- The lesion eye has at least grade 2 limbal stem cell deficiency
- The lesion eye has limbal stem cell deficiency causing recurrent corneal erosion and neovascularization ingrowth
- The symptoms last for at least 6 months and do not improve with medication
Key exclusion criteria (5 listed)
- The symptoms improve spontaneously or with medication
- Someone who can not be examined regularly after the operation
- Poor prognosis
- Severe lagophthalmos or trichiasis that has not been corrected
- Ocular infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Best corrected visual acuity change
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
- Background: PubMed 29800578Borroni D, Wowra B, Romano V, Boyadzhieva M, Ponzin D, Ferrari S, Ahmad S, Parekh M. Simple limbal epithelial transplantation: a review on current approach and future directions. Surv Ophthalmol. 2018 Nov-Dec;63(6):869-874. doi: 10.1016/j.survophthal.2018.05.003. Epub 2018 May 22.
- Background: PubMed 28407620Iyer G, Srinivasan B, Agarwal S, Tarigopula A. Outcome of allo simple limbal epithelial transplantation (alloSLET) in the early stage of ocular chemical injury. Br J Ophthalmol. 2017 Jun;101(6):828-833. doi: 10.1136/bjophthalmol-2016-309045. Epub 2016 Oct 8.
- Individual participant dataSharing planned: No. No IPD sharing in this study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei-Li Chen, phD study chair
National Taiwan University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Limbal Stem-cell Deficiency, run by National Taiwan University Hospital at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei-Li Chen, phD (+886223123456 ext. 65168, cwlntuh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numbers of patients with clinical success (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04021134, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2019.