Corneal DiseasePhase 1/2NCT02148016
Corneal Epithelium Repair and Therapy Using Autologous Limbal Stem Cell Transplantation
A Phase 1/2 study testing LSCs and amniotic membrane (Modified Technique), Amniotic membrane only (Traditional Technique) and PRK, LSCs, and amniotic membrane (Modified Technique) in people with Corneal Disease and Pterygium, run by Sun Yat-sen University at 1 site in China.
Trial summary
Corneal disease is a leading cause of blindness in the world. A shortage of corneal donor tissue has prevented many patients from regaining vision. Additionally, refractive error such as myopia is a major cause of impaired visual function worldwide. Read more about this study
- Who is it for?
- Ages 10 to 70 years
- Conditions the study is for
- Corneal Disease, Pterygium, Myopia
- What is being tested?
- LSCs and amniotic membrane (Modified Technique), Amniotic membrane only (Traditional Technique) and PRK, LSCs, and amniotic membrane (Modified Technique)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Dec 2012to Sep 2014
- 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 10 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Monocular corneal chemical injury or pterygium, or refractive error greater than +/- 2D
- Informed consent signed by patient or legal guardian
Who cannot join
- Patients with a history of corneal perforation or surgery
- Patients with other eye diseases
- Patients with a history of severe cardiovascular, liver, kidney, endocrine, and hematopoietic disease, diabetes, or immune deficiency disorders
- Pregnant or lactating women
- Patients who are participating in other clinical trials
- Patients with a history of mental illness who are unable to give informed consent or follow up according to the study protocol.
Trial locations and contacts
1 site in 1 country.
Ying Lin, MD, PhD contact
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou
Yizhi Liu, MD, PhD
About this study
Corneal disease is a leading cause of blindness in the world. A shortage of corneal donor tissue has prevented many patients from regaining vision. Additionally, refractive error such as myopia is a major cause of impaired visual function worldwide. Although refractive error is correctable by procedures that modify the refractive power of the cornea, these procedures often weaken corneal integrity and have risk of complications. This study aims to evaluate the safety and efficacy of corneal surface epithelium repair and regeneration in the treatment of corneal surface diseases and refractive error using autologous limbal stem cell transplantation.
Read the detailed description
The corneal surface is comprised of a unique type of non-keratinized epithelial cell. These cells are arranged in an orderly fashion, which is essential for vision by maintaining the transparency of the visual axis.
Chemical injury and pterygia may damage the limbus, the zone between the cornea and the bulbar conjunctiva, and cause limbal stem cell (LSC) deficiency. They represent major treatable causes of vision loss worldwide. A shortage of corneal donor tissue prevents many patients from regaining vision, necessitating new treatment strategies to circumvent this limitation. Transplantation of stem cells represents an appealing therapeutic strategy in regenerative medicine, and the use of endogenous stem cells provides a possible solution to the problem of immune rejection.
Currently, LASIK (laser-assisted in situ keratomileusis) is the most commonly performed laser vision correction procedure in the world (over 10 million surgeries each year); however, it has a major disadvantage in that it weakens corneal integrity and structure and predisposes to complications such as keratectasia or keratoconus (bulging of the cornea) and vision loss. An alternative is photo-refractive keratectomy (PRK), which removes the corneal epithelium and anterior stroma while minimizing the incidence of keratectasia or keratoconus. The primary drawbacks of PRK are that it requires a longer recovery time (the corneal epithelium must regenerate from the patient's own LSCs) and may result in blurry vision and pain due to corneal pain nerve fiber exposure after removal of the epithelium. Coverage of exposed corneal stroma tissue immediately after surgery with LSC-derived corneal epithelial cells will solve this key bottleneck and make laser eye surgery safer and more comfortable for millions of people.
It is known that corneal renewal and repair are mediated by stem cells in the limbus. Autologous LSC transplantation has been reported previously (Rama et al.). However, mouse feeder cells were required to expand LSCs in culture. We have successfully developed a feeder-free, chemically defined medium in which to expand LSCs. These expanded LSCs can repair and regenerate corneal surfaces (Ouyang et al., in press).
Hypothesis: The trial will demonstrate whether a new technique, transplantation of LSCs expanded from limbal tissue of the uninjured eye, can improve the visual function of patients with unilateral corneal ocular surface disease. In addition, it will show whether there is more rapid recovery and improved visual outcomes following PRK if expanded LSCs are used to cover the cornea. The study will also compare the incidence of complications and characterize visual outcomes in patients treated with the new technique versus the control technique.
- Conditions
- Corneal Disease, Pterygium, Myopia, Hyperopia
- Being tested
- LSCs and amniotic membrane (Modified Technique), Amniotic membrane only (Traditional Technique), PRK, LSCs, and amniotic membrane (Modified Technique), PRK only (Traditional Technique), Levofloxacin
- Keywords
- Corneal disorders, Chemical injury, Pterygium, Refractive error, Myopia, Hyperopia, Cornea, Monocular, Transparent, Transplantation, Visual function
- Medical subject headings
- Corneal Diseases, Pterygium, Myopia, Hyperopia, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LSCs and amniotic membrane (Modified Technique)Procedure or surgery
Limbal stem cells (LSCs) from the contralateral eye will be harvested and expanded in feeder-free, chemically defined media for one week on a collagen-coated contact lens. The LSCs on contact lens will be transplanted onto a corneal surface in vivo, following removal of scar tissue due to chemical injury or pterygium. The contact lens will then be covered with amniotic membrane to secure it in place.
The eye will be treated with antibiotics (levofloxacin) and steroids (betamethasone), and then patched.
Amniotic membrane only (Traditional Technique)Procedure or surgery
Amniotic membrane alone will be used to cover the corneal surface, after removal of scar tissue from a chemical injury or pterygium.
PRK, LSCs, and amniotic membrane (Modified Technique)Procedure or surgery
Limbal stem cells (LSCs) from the contralateral eye will be harvested and expanded in feeder-free, chemically defined media for one week on a collagen-coated contact lens. The LSCs on contact lens will be transplanted onto a corneal surface in vivo, following photo-refractive keratectomy (PRK). The contact lens will then be covered with amniotic membrane to secure it in place.
The eye will be treated with antibiotics (levofloxacin) and steroids (betamethasone), and then patched.
PRK only (Traditional Technique)Procedure or surgery
PRK alone will be performed.
LevofloxacinDrug
BetamethasoneDrug
Limbal stem cells (LSCs)Drug
| Study group | Role | What they receive |
|---|---|---|
| LSCs and amniotic membrane (Modified Technique) | Experimental | Limbal stem cells (LSCs) from the contralateral eye will be harvested and expanded in feeder-free, chemically defined media for one week on a collagen-coated contact lens. The LSCs on contact lens will be transplanted onto a corneal surface in vivo, following removal of scar tissue due to chemical injury or pterygium. The contact lens will then be covered with amniotic membrane to secure it in place.
The eye will be treated with antibiotics (levofloxacin) and steroids (betamethasone), and then patched. Receives: Procedure: LSCs and amniotic membrane (Modified Technique); Drug: Levofloxacin; Drug: Betamethasone |
| Amniotic membrane only (Traditional Technique) | Active comparator | Amniotic membrane alone will be used to cover the corneal surface, after removal of scar tissue from a chemical injury or pterygium. Receives: Procedure: Amniotic membrane only (Traditional Technique) |
| PRK, LSCs, and amniotic membrane (Modified Technique) | Experimental | Limbal stem cells (LSCs) from the contralateral eye will be harvested and expanded in feeder-free, chemically defined media for one week on a collagen-coated contact lens. The LSCs on contact lens will be transplanted onto a corneal surface in vivo, following photo-refractive keratectomy (PRK). The contact lens will then be covered with amniotic membrane to secure it in place.
The eye will be treated with antibiotics (levofloxacin) and steroids (betamethasone), and then patched. Receives: Procedure: PRK, LSCs, and amniotic membrane (Modified Technique); Drug: Levofloxacin; Drug: Betamethasone; Drug: Limbal stem cells (LSCs) |
| PRK only (Traditional Technique) | Active comparator | PRK alone will be performed. Receives: Procedure: PRK only (Traditional Technique) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite measure of visual function in eyes treated for corneal ocular surface disease.
Slitlamp examination, in addition to measurement of visual acuity and intraocular pressure.
Measured: up to 1 year
Composite measure of visual function in eyes after photo-refractive keratectomy (PRK)
Measured: up to 1 year
Secondary outcomes (1)
Incidence of transparency of the cornea
Anterior segment photography and OCT as well as pentacam photography will be performed post treatment on day 1, week 1, week 2, month 1, month 3, month 6, and year 1, in order to assess transparency and curvature of the cornea.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startDec 2012
- Primary completionJun 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Corneal DiseaseStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yizhi Liu, MD, PhD, Sun Yat-sen University
- Investigators
- Yizhi Liu, MD, PhD, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02148016
- Sponsor's protocol ID
- 2013SKL005
- Status last verified
- May 2014
- First submitted
- 19 May 2014
- Last updated
- 28 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Kolli S, Ahmad S, Mudhar HS, Meeny A, Lako M, Figueiredo FC. Successful application of ex vivo expanded human autologous oral mucosal epithelium for the treatment of total bilateral limbal stem cell deficiency. Stem Cells. 2014 Aug;32(8):2135-46. doi: 10.1002/stem.1694.
PubMed 24590515Zakaria N, Possemiers T, Dhubhghaill SN, Leysen I, Rozema J, Koppen C, Timmermans JP, Berneman Z, Tassignon MJ. Results of a phase I/II clinical trial: standardized, non-xenogenic, cultivated limbal stem cell transplantation. J Transl Med. 2014 Mar 3;12:58. doi: 10.1186/1479-5876-12-58.
PubMed 24589151Vazirani J, Basu S, Kenia H, Ali MH, Kacham S, Mariappan I, Sangwan V. Unilateral partial limbal stem cell deficiency: contralateral versus ipsilateral autologous cultivated limbal epithelial transplantation. Am J Ophthalmol. 2014 Mar;157(3):584-90.e1-2. doi: 10.1016/j.ajo.2013.11.011. Epub 2013 Nov 19.
PubMed 24269851Wu Z, Zhou Q, Duan H, Wang X, Xiao J, Duan H, Li N, Li C, Wan P, Liu Y, Song Y, Zhou C, Huang Z, Wang Z. Reconstruction of auto-tissue-engineered lamellar cornea by dynamic culture for transplantation: a rabbit model. PLoS One. 2014 Apr 4;9(4):e93012. doi: 10.1371/journal.pone.0093012. eCollection 2014.
PubMed 24705327Konomi K, Satake Y, Shimmura S, Tsubota K, Shimazaki J. Long-term results of amniotic membrane transplantation for partial limbal deficiency. Cornea. 2013 Aug;32(8):1110-5. doi: 10.1097/ICO.0b013e31828d06d2.
PubMed 23615271Rama P, Matuska S, Paganoni G, Spinelli A, De Luca M, Pellegrini G. Limbal stem-cell therapy and long-term corneal regeneration. N Engl J Med. 2010 Jul 8;363(2):147-55. doi: 10.1056/NEJMoa0905955. Epub 2010 Jun 23.
PubMed 20573916Ouyang H, Xue Y, Lin Y, Zhang X, Xi L, Patel S, Cai H, Luo J, Zhang M, Zhang M, Yang Y, Li G, Li H, Jiang W, Yeh E, Lin J, Pei M, Zhu J, Cao G, Zhang L, Yu B, Chen S, Fu XD, Liu Y, Zhang K. WNT7A and PAX6 define corneal epithelium homeostasis and pathogenesis. Nature. 2014 Jul 17;511(7509):358-61. doi: 10.1038/nature13465. Epub 2014 Jul 2.
PubMed 25030175
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corneal Epithelium Repair and Therapy Using Autologous Limbal Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT02148016
- Acronym / sponsor ID
- 2013SKL005
- Conditions
- Corneal Disease, Pterygium, Myopia, Hyperopia
- Keywords
- Corneal disorders, Chemical injury, Pterygium, Refractive error, Myopia, Hyperopia, Cornea, Monocular
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 28 May 2014 (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.
Corneal disease is a leading cause of blindness in the world. A shortage of corneal donor tissue has prevented many patients from regaining vision. Additionally, refractive error such as myopia is a major cause of impaired visual function worldwide. Although refractive error is correctable by procedures that modify the refractive power of the cornea, these procedures often weaken corneal integrity and have risk of complications. This study aims to evaluate the safety and efficacy of corneal surface epithelium repair and regeneration in the treatment of corneal surface diseases and refractive error using autologous limbal stem cell transplantation.
Detailed description
The corneal surface is comprised of a unique type of non-keratinized epithelial cell. These cells are arranged in an orderly fashion, which is essential for vision by maintaining the transparency of the visual axis.
Chemical injury and pterygia may damage the limbus, the zone between the cornea and the bulbar conjunctiva, and cause limbal stem cell (LSC) deficiency. They represent major treatable causes of vision loss worldwide. A shortage of corneal donor tissue prevents many patients from regaining vision, necessitating new treatment strategies to circumvent this limitation. Transplantation of stem cells represents an appealing therapeutic strategy in regenerative medicine, and the use of endogenous stem cells provides a possible solution to the problem of immune rejection.
Currently, LASIK (laser-assisted in situ keratomileusis) is the most commonly performed laser vision correction procedure in the world (over 10 million surgeries each year); however, it has a major disadvantage in that it weakens corneal integrity and structure and predisposes to complications such as keratectasia or keratoconus (bulging of the cornea) and vision loss. An alternative is photo-refractive keratectomy (PRK), which removes the corneal epithelium and anterior stroma while minimizing the incidence of keratectasia or keratoconus. The primary drawbacks of PRK are that it requires a longer recovery time (the corneal epithelium must regenerate from the patient's own LSCs) and may result in blurry vision and pain due to corneal pain nerve fiber exposure after removal of the epithelium. Coverage of exposed corneal stroma tissue immediately after surgery with LSC-derived corneal epithelial cells will solve this key bottleneck and make laser eye surgery safer and more comfortable for millions of people.
It is known that corneal renewal and repair are mediated by stem cells in the limbus. Autologous LSC transplantation has been reported previously (Rama et al.). However, mouse feeder cells were required to expand LSCs in culture. We have successfully developed a feeder-free, chemically defined medium in which to expand LSCs. These expanded LSCs can repair and regenerate corneal surfaces (Ouyang et al., in press).
Hypothesis: The trial will demonstrate whether a new technique, transplantation of LSCs expanded from limbal tissue of the uninjured eye, can improve the visual function of patients with unilateral corneal ocular surface disease. In addition, it will show whether there is more rapid recovery and improved visual outcomes following PRK if expanded LSCs are used to cover the cornea. The study will also compare the incidence of complications and characterize visual outcomes in patients treated with the new technique versus the control technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LSCs and amniotic membrane (Modified Technique) | Experimental | Procedure: LSCs and amniotic membrane (Modified Technique), Drug: Levofloxacin, Drug: BetamethasoneLimbal stem cells (LSCs) from the contralateral eye will be harvested and expanded in feeder-free, chemically defined media for one week on a collagen-coated contact lens. The LSCs on contact lens will be transplanted onto a corneal surface in vivo, following removal of scar tissue due to chemical injury or pterygium. The contact lens will then be covered with amniotic membrane to secure it in place. The eye will be treated with antibiotics (levofloxacin) and steroids (betamethasone), and then patched. |
| Amniotic membrane only (Traditional Technique) | Active comparator | Procedure: Amniotic membrane only (Traditional Technique)Amniotic membrane alone will be used to cover the corneal surface, after removal of scar tissue from a chemical injury or pterygium. |
| PRK, LSCs, and amniotic membrane (Modified Technique) | Experimental | Procedure: PRK, LSCs, and amniotic membrane (Modified Technique), Drug: Levofloxacin, Drug: Betamethasone, Drug: Limbal stem cells (LSCs)Limbal stem cells (LSCs) from the contralateral eye will be harvested and expanded in feeder-free, chemically defined media for one week on a collagen-coated contact lens. The LSCs on contact lens will be transplanted onto a corneal surface in vivo, following photo-refractive keratectomy (PRK). The contact lens will then be covered with amniotic membrane to secure it in place. The eye will be treated with antibiotics (levofloxacin) and steroids (betamethasone), and then patched. |
| PRK only (Traditional Technique) | Active comparator | Procedure: PRK only (Traditional Technique)PRK alone will be performed. |
Who may qualify
- Ages
- 10 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Monocular corneal chemical injury or pterygium, or refractive error greater than +/- 2D
- Informed consent signed by patient or legal guardian
Key exclusion criteria (6 listed)
- Patients with a history of corneal perforation or surgery
- Patients with other eye diseases
- Patients with a history of severe cardiovascular, liver, kidney, endocrine, and hematopoietic disease, diabetes, or immune deficiency disorders
- Pregnant or lactating women
- Patients who are participating in other clinical trials
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 |
|---|---|---|
| LSCs and amniotic membrane (Modified Technique)Limbal stem cells (LSCs) from the contralateral eye will be harvested and expanded in feeder-free, chemically defined media for one week on a collagen-coated contact lens. The LSCs on contact lens will be transplanted onto a corneal surface in vivo, following removal of scar tissue due to chemical injury or pterygium. The contact lens will then be covered with amniotic membrane to secure it in place. The eye will be treated with antibiotics (levofloxacin) and steroids (betamethasone), and then patched. | Procedure or surgery | LSCs and amniotic membrane (Modified Technique) |
| Amniotic membrane only (Traditional Technique)Amniotic membrane alone will be used to cover the corneal surface, after removal of scar tissue from a chemical injury or pterygium. | Procedure or surgery | Amniotic membrane only (Traditional Technique) |
| PRK, LSCs, and amniotic membrane (Modified Technique)Limbal stem cells (LSCs) from the contralateral eye will be harvested and expanded in feeder-free, chemically defined media for one week on a collagen-coated contact lens. The LSCs on contact lens will be transplanted onto a corneal surface in vivo, following photo-refractive keratectomy (PRK). The contact lens will then be covered with amniotic membrane to secure it in place. The eye will be treated with antibiotics (levofloxacin) and steroids (betamethasone), and then patched. | Procedure or surgery | PRK, LSCs, and amniotic membrane (Modified Technique) |
| PRK only (Traditional Technique)PRK alone will be performed. | Procedure or surgery | PRK only (Traditional Technique) |
| Levofloxacin | Drug | LSCs and amniotic membrane (Modified Technique), PRK, LSCs, and amniotic membrane (Modified Technique) |
| Betamethasone | Drug | LSCs and amniotic membrane (Modified Technique), PRK, LSCs, and amniotic membrane (Modified Technique) |
| Limbal stem cells (LSCs) | Drug | PRK, LSCs, and amniotic membrane (Modified Technique) |
Primary outcome
Composite measure of visual function in eyes treated for corneal ocular surface disease.
Time frame: up to 1 year
Slitlamp examination, in addition to measurement of visual acuity and intraocular pressure.
Composite measure of visual function in eyes after photo-refractive keratectomy (PRK)
Time frame: up to 1 year
1 secondary outcome
Incidence of transparency of the cornea
Time frame: up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2014.
- Background: PubMed 24590515Kolli S, Ahmad S, Mudhar HS, Meeny A, Lako M, Figueiredo FC. Successful application of ex vivo expanded human autologous oral mucosal epithelium for the treatment of total bilateral limbal stem cell deficiency. Stem Cells. 2014 Aug;32(8):2135-46. doi: 10.1002/stem.1694.
- Background: PubMed 24589151Zakaria N, Possemiers T, Dhubhghaill SN, Leysen I, Rozema J, Koppen C, Timmermans JP, Berneman Z, Tassignon MJ. Results of a phase I/II clinical trial: standardized, non-xenogenic, cultivated limbal stem cell transplantation. J Transl Med. 2014 Mar 3;12:58. doi: 10.1186/1479-5876-12-58.
- Background: PubMed 24269851Vazirani J, Basu S, Kenia H, Ali MH, Kacham S, Mariappan I, Sangwan V. Unilateral partial limbal stem cell deficiency: contralateral versus ipsilateral autologous cultivated limbal epithelial transplantation. Am J Ophthalmol. 2014 Mar;157(3):584-90.e1-2. doi: 10.1016/j.ajo.2013.11.011. Epub 2013 Nov 19.
- Background: PubMed 24705327Wu Z, Zhou Q, Duan H, Wang X, Xiao J, Duan H, Li N, Li C, Wan P, Liu Y, Song Y, Zhou C, Huang Z, Wang Z. Reconstruction of auto-tissue-engineered lamellar cornea by dynamic culture for transplantation: a rabbit model. PLoS One. 2014 Apr 4;9(4):e93012. doi: 10.1371/journal.pone.0093012. eCollection 2014.
- Background: PubMed 23615271Konomi K, Satake Y, Shimmura S, Tsubota K, Shimazaki J. Long-term results of amniotic membrane transplantation for partial limbal deficiency. Cornea. 2013 Aug;32(8):1110-5. doi: 10.1097/ICO.0b013e31828d06d2.
- Background: PubMed 20573916Rama P, Matuska S, Paganoni G, Spinelli A, De Luca M, Pellegrini G. Limbal stem-cell therapy and long-term corneal regeneration. N Engl J Med. 2010 Jul 8;363(2):147-55. doi: 10.1056/NEJMoa0905955. Epub 2010 Jun 23.
- Background: PubMed 25030175Ouyang H, Xue Y, Lin Y, Zhang X, Xi L, Patel S, Cai H, Luo J, Zhang M, Zhang M, Yang Y, Li G, Li H, Jiang W, Yeh E, Lin J, Pei M, Zhu J, Cao G, Zhang L, Yu B, Chen S, Fu XD, Liu Y, Zhang K. WNT7A and PAX6 define corneal epithelium homeostasis and pathogenesis. Nature. 2014 Jul 17;511(7509):358-61. doi: 10.1038/nature13465. Epub 2014 Jul 2.
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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.
Ying Lin, MD, PhD contact
Yizhi Liu, MD, PhD principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LSCs and amniotic membrane (Modified Technique), Amniotic membrane only (Traditional Technique) and PRK, LSCs, and amniotic membrane (Modified Technique) in people with Corneal Disease and Pterygium, run by Sun Yat-sen University at 1 site in China.
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 2 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 28 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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.
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?
Contact Ying Lin, MD, PhD (lylytulip@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite measure of visual function in eyes treated for corneal ocular surface disease. (time frame: up to 1 year). The study lists 2 primary outcomes in all. 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 NCT02148016, which also lists 7 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 28 May 2014.