Limbal Stem Cell DeficiencyNCT02149732
Clinical Trial on the Effect of Autologous Oral Mucosal Epithelial Sheet Transplantation
A study testing cultivated oral mucosal epithelial sheet transplantation in people with Limbal Stem Cell Deficiency and Stevens-johnson Syndrome, run by Seoul National University Hospital at 2 sites in South Korea.
Trial summary
To investigate the effect of ocular surface reconstruction and assess the safety in cultivated oral mucosal epithelial cell sheet transplantation (COMET) regarding patients with cicatricial change of ocular surface. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Limbal Stem Cell Deficiency, Stevens-johnson Syndrome, Ocular Cicatricial Pemphigoid
- What is being tested?
- cultivated oral mucosal epithelial sheet transplantation
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 2 sitesSouth Korea
- Study dates
- May 2014to Dec 2016
- Phase
- Expanded access
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patient with eye which has limbal stem cell deficiency and conjunctivalization of cornea
- patient who shows no improvement after limbal tissue or amniotic membrane transplantation, or who has difficulty in receiving long-term immunosuppressive treatment
- patient who agree this clinical trial
- patient with the eyes in which best corrected visual acuity is less than counting finger
- patient who is older than sixteen year old
Who cannot join
- patient who has relevant corneal transparency
- patient who is on the pregnancy or has a plan of pregnancy within 1 year
- patient who has corneal infection
- patient who has diagnosis of HBV, HCV, HIV, syphilis
- patinet who has past medial history of antinal, myocardial infarction, heart failure, arrhythmia, brain stroke, cerebrovascular disease
- patient who has malignancy
- patient who shows hypersensitivity to bovine protein.
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
- Available
Seoul National University Hospital
Seoul, Seoul, 110-744
Mee Kum Kim, MD, PhD, 82-10-6277-0798, kmk9@snu.ac.kr
Dong Hyun Kim, MD, 82-10-3737-0975, amidfree@gmail.com
- Available
Seoul National Unversity Hospital
Seoul, Seoul, 110-744
Mee Kum Kim, MD, PhD, 82-10-6277-0798, kmk9@snu.ac.kr
About this study
Official title: An Investigator-initiated Trial (IIT) on the Effect of Autologous Oral Mucosal Epithelial Sheet Transplantation in Corneal Limbal Deficiency Patients
To investigate the effect of ocular surface reconstruction and assess the safety in cultivated oral mucosal epithelial cell sheet transplantation (COMET) regarding patients with cicatricial change of ocular surface.
Read the detailed description
Interventional study for treatment of patients with cicatricial change of ocular surface.
Single Group: (Limbal stem cell deficiency group)
Treatment: After cultivating autologous Oral mucosal epithelial cell sheet, the sheet will be transplanted to the ocular surface of the patients
Inclusion criteria
- patient with eye which has limbal stem cell deficiency and conjunctivalization of cornea
- patient who shows no improvement after limbal tissue or amniotic membrane transplantation, or who has difficulty in receiving long-term immunosuppressive treatment
- patient who agree this clinical trial
- patient with the eyes in which best corrected visual acuity is less than counting finger
- patient who is older than sixteen year old
Exclusion criteria
- patient who has relevant corneal transparency
- patient who is on the pregnancy or has a plan of pregnancy within 1 year
- patient who has corneal infection
- patient who has diagnosis of HBV, HCV, HIV, syphilis
- patinet who has past medial history of antinal, myocardial infarction, heart failure, arrhythmia, brain stroke, cerebrovascular disease
- patient who has malignancy
- patient who shows hypersensitivity to bovine protein.
Primary outcome Epithelization of corneal surface (6 months after cell sheet transplantation)
Secondary outcome Visual acuity (6 months after cell sheet transplantation)
- Conditions
- Limbal Stem Cell Deficiency, Stevens-johnson Syndrome, Ocular Cicatricial Pemphigoid, Chemical Burn
- Being tested
- cultivated oral mucosal epithelial sheet transplantation
- Keywords
- Limbal stem cell deficiency, Cultivated oral mucosal cell sheet transplantation, Ocular surface reconstruction
- Medical subject headings
- Limbal Stem Cell Deficiency, Stevens-Johnson Syndrome, Pemphigoid, Benign Mucous Membrane, Burns, Chemical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cultivated oral mucosal epithelial sheet transplantationBiological
Autologous cultivated oral mucosal epithelial cell sheet transplantation using oral mucosal adult stem cells in the patients with intractable corneal limbal deficiency
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (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.
- More trials run by Seoul National 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea
- Responsible party
- Sponsor
- Investigators
- Mee Kum Kim, MD, PhD, Principal investigator, Department of Ophthalmology, Seoul National University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02149732
- Sponsor's protocol ID
- COMET trial
- Other IDs
- MKKim
- Status last verified
- Apr 2016
- First submitted
- 14 May 2014
- Last updated
- 20 Apr 2016
- Results posted
- No
Publications
Nishida K, Yamato M, Hayashida Y, Watanabe K, Yamamoto K, Adachi E, Nagai S, Kikuchi A, Maeda N, Watanabe H, Okano T, Tano Y. Corneal reconstruction with tissue-engineered cell sheets composed of autologous oral mucosal epithelium. N Engl J Med. 2004 Sep 16;351(12):1187-96. doi: 10.1056/NEJMoa040455.
PubMed 15371576
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator-initiated Trial (IIT) on the Effect of Autologous Oral Mucosal Epithelial Sheet Transplantation in Corneal Limbal Deficiency Patients
- ClinicalTrials.gov ID
- NCT02149732
- Acronym / sponsor ID
- COMET trial
- Conditions
- Limbal Stem Cell Deficiency, Stevens-johnson Syndrome, Ocular Cicatricial Pemphigoid, Chemical Burn
- Keywords
- Limbal stem cell deficiency, Cultivated oral mucosal cell sheet transplantation, Ocular surface reconstruction
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea
- Study start
- May 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 29 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.
To investigate the effect of ocular surface reconstruction and assess the safety in cultivated oral mucosal epithelial cell sheet transplantation (COMET) regarding patients with cicatricial change of ocular surface.
Detailed description
Interventional study for treatment of patients with cicatricial change of ocular surface.
Single Group: (Limbal stem cell deficiency group)
Treatment: After cultivating autologous Oral mucosal epithelial cell sheet, the sheet will be transplanted to the ocular surface of the patients
Inclusion criteria
- patient with eye which has limbal stem cell deficiency and conjunctivalization of cornea
- patient who shows no improvement after limbal tissue or amniotic membrane transplantation, or who has difficulty in receiving long-term immunosuppressive treatment
- patient who agree this clinical trial
- patient with the eyes in which best corrected visual acuity is less than counting finger
- patient who is older than sixteen year old
Exclusion criteria
- patient who has relevant corneal transparency
- patient who is on the pregnancy or has a plan of pregnancy within 1 year
- patient who has corneal infection
- patient who has diagnosis of HBV, HCV, HIV, syphilis
- patinet who has past medial history of antinal, myocardial infarction, heart failure, arrhythmia, brain stroke, cerebrovascular disease
- patient who has malignancy
- patient who shows hypersensitivity to bovine protein.
Primary outcome Epithelization of corneal surface (6 months after cell sheet transplantation)
Secondary outcome Visual acuity (6 months after cell sheet transplantation)
Study design
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- patient with eye which has limbal stem cell deficiency and conjunctivalization of cornea
- patient who shows no improvement after limbal tissue or amniotic membrane transplantation, or who has difficulty in receiving long-term immunosuppressive treatment
- patient who agree this clinical trial
- patient with the eyes in which best corrected visual acuity is less than counting finger
- patient who is older than sixteen year old
Key exclusion criteria (7 listed)
- patient who has relevant corneal transparency
- patient who is on the pregnancy or has a plan of pregnancy within 1 year
- patient who has corneal infection
- patient who has diagnosis of HBV, HCV, HIV, syphilis
- patinet who has past medial history of antinal, myocardial infarction, heart failure, arrhythmia, brain stroke, cerebrovascular disease
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 |
|---|---|---|
| cultivated oral mucosal epithelial sheet transplantationAutologous cultivated oral mucosal epithelial cell sheet transplantation using oral mucosal adult stem cells in the patients with intractable corneal limbal deficiency | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2016.
- Background: PubMed 15371576Nishida K, Yamato M, Hayashida Y, Watanabe K, Yamamoto K, Adachi E, Nagai S, Kikuchi A, Maeda N, Watanabe H, Okano T, Tano Y. Corneal reconstruction with tissue-engineered cell sheets composed of autologous oral mucosal epithelium. N Engl J Med. 2004 Sep 16;351(12):1187-96. doi: 10.1056/NEJMoa040455.
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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.
Mee Kum Kim, MD, PhD principal investigator
Department of Ophthalmology, Seoul National University College of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cultivated oral mucosal epithelial sheet transplantation in people with Limbal Stem Cell Deficiency and Stevens-johnson Syndrome, run by Seoul National University Hospital at 2 sites in South Korea.
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 7 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 20 Apr 2016. 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 South Korea. 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 Mee Kum Kim, MD, PhD (82-10-6277-0798, kmk9@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02149732, 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 20 Apr 2016; AzTrials last refreshed its copy on 8 Nov 2026.