Limbal Stem Cell DeficiencyPhase 1/2NCT03015779
Transplantation of Autologous Oral Mucosal Epithelial Stem Cell Sheet for Treating Limbal Stem Cell Deficiency Disease
A Phase 1/2 study testing cultured autologous oral mucosal epithelial cell sheet in people with Limbal Stem Cell Deficiency, run by He Eye Hospital.
Trial summary
The aim of this trials investigates the therapeutic effects of application autologous oral mucosal epithelial cell sheets in the treatment of limbal stem cell deficiency disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Limbal Stem Cell Deficiency
- What is being tested?
- cultured autologous oral mucosal epithelial cell sheet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Dec 2018
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged>=18 years old
- Normal intraocular pressure
- Normal Eyelid
- No cataract and retinal disease
- No ulcers and tumor in the mouth
Who cannot join
- Severe Systemic infection
- History of acute phase of ocular and oral inflammation
- History of hyper sensibility or allergy to antibiotics or serum
- Women who are or may be pregnant
- Patients with infectious diseases
- Patients with other complications
About this study
The aim of this trials investigates the therapeutic effects of application autologous oral mucosal epithelial cell sheets in the treatment of limbal stem cell deficiency disease.
Read the detailed description
A number of external factors can result in limbal stem cell deficiency(LSCD), causing pain, pathological corneal epithelium regeneration, inflammation reaction and seriously visual loss. For patients with unilaterally damaged eye, transplantation of limbal tissue from the healthy eye can be used in the past years in the risk of inducing limbal stem cell damaged in the healthy eye. While graft of human leukocyte antigen matched allogenic limbal stem cells require immune suppressive medications, it can cause side effects in the body. Over the past 10 years, the clinical trials of application of cultured autologous oral mucosal epithelial cell sheet to treat LSCD have been emerged as a promising strategy in many countries. However, little study has been reported in China. This study investigates the therapeutic effects of application autologous oral mucosal epithelial cell sheets in the treatment of limbal stem cell deficiency disease in China.
- Conditions
- Limbal Stem Cell Deficiency
- Being tested
- cultured autologous oral mucosal epithelial cell sheet
- Medical subject headings
- Limbal Stem Cell Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cultured autologous oral mucosal epithelial cell sheetOther
a prospective study,Before and after self control
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | cultured autologous oral mucosal epithelial cell sheet Receives: Other: cultured autologous oral mucosal epithelial cell sheet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The area of reepithelialization of corneal epithelium
The preoperative status of the eye will be recorded on the basis of clinical drawings and pre-and post-operative photographs. These pictures will be sent to two corneal experts in order to evaluate the results.
Judgement criterion: the results will be tested with a slit lamp:
Normal: no epithelial loss; Mild: the area of epithelial loss <1/3; Moderate: the area of epithelial loss >1/3 <2/3; Severe: the area of epithelial loss> 2/3
Measured: 3 months
Secondary outcomes (2)
Improvement of best correct visual acuity
Measured: one year
Decrease of corneal neovascularization
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Limbal Stem Cell DeficiencyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- He Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03015779
- Sponsor's protocol ID
- 20161029
- Status last verified
- Jan 2017
- First submitted
- 5 Jan 2017
- Last updated
- 10 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Zhang M, Zheng Y, Yao T, Wang L, Yu H, Wang Z. Impact of Smoking on the Efficacy of Human Autologous Oral Mucosal Epithelial Cell Sheet Transplantation for Treating Limbal Stem Cell Deficiency. Stem Cells Int. 2026 Jan 5;2026:3769266. doi: 10.1155/sci/3769266. eCollection 2026.
PubMed 41503585
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transplantation of Autologous Oral Mucosal Epithelial Stem Cell Sheet for Treating Limbal Stem Cell Deficiency Disease
- ClinicalTrials.gov ID
- NCT03015779
- Acronym / sponsor ID
- 20161029
- Conditions
- Limbal Stem Cell Deficiency
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- He Eye HospitalUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 10 Jan 2017 (estimated)
- 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.
The aim of this trials investigates the therapeutic effects of application autologous oral mucosal epithelial cell sheets in the treatment of limbal stem cell deficiency disease.
Detailed description
A number of external factors can result in limbal stem cell deficiency(LSCD), causing pain, pathological corneal epithelium regeneration, inflammation reaction and seriously visual loss. For patients with unilaterally damaged eye, transplantation of limbal tissue from the healthy eye can be used in the past years in the risk of inducing limbal stem cell damaged in the healthy eye. While graft of human leukocyte antigen matched allogenic limbal stem cells require immune suppressive medications, it can cause side effects in the body. Over the past 10 years, the clinical trials of application of cultured autologous oral mucosal epithelial cell sheet to treat LSCD have been emerged as a promising strategy in many countries. However, little study has been reported in China. This study investigates the therapeutic effects of application autologous oral mucosal epithelial cell sheets in the treatment of limbal stem cell deficiency disease in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: cultured autologous oral mucosal epithelial cell sheetcultured autologous oral mucosal epithelial cell sheet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female aged>=18 years old
- Normal intraocular pressure
- Normal Eyelid
- No cataract and retinal disease
- No ulcers and tumor in the mouth
Key exclusion criteria (6 listed)
- Severe Systemic infection
- History of acute phase of ocular and oral inflammation
- History of hyper sensibility or allergy to antibiotics or serum
- Women who are or may be pregnant
- Patients with infectious diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cultured autologous oral mucosal epithelial cell sheeta prospective study,Before and after self control | Other | experimental group |
Primary outcome
The area of reepithelialization of corneal epithelium
Time frame: 3 months
The preoperative status of the eye will be recorded on the basis of clinical drawings and pre-and post-operative photographs. These pictures will be sent to two corneal experts in order to evaluate the results. Judgement criterion: the results will be tested with a slit lamp: Normal: no epithelial loss; Mild: the area of epithelial loss <1/3; Moderate: the area of epithelial loss >1/3 <2/3; Severe: the area of epithelial loss> 2/3
2 secondary outcomes
Improvement of best correct visual acuity
Time frame: one year
Decrease of corneal neovascularization
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2017.
- Derived from this study: PubMed 41503585Zhang M, Zheng Y, Yao T, Wang L, Yu H, Wang Z. Impact of Smoking on the Efficacy of Human Autologous Oral Mucosal Epithelial Cell Sheet Transplantation for Treating Limbal Stem Cell Deficiency. Stem Cells Int. 2026 Jan 5;2026:3769266. doi: 10.1155/sci/3769266. eCollection 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing cultured autologous oral mucosal epithelial cell sheet in people with Limbal Stem Cell Deficiency, run by He Eye Hospital.
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 5 inclusion and 6 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 10 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The area of reepithelialization of corneal epithelium (time frame: 3 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 NCT03015779, which also lists 1 linked publication.
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 10 Jan 2017.