Unilateral Limbal Stem Cell InsufficiencyPhase 1NCT01377311
The Application of Cultured Cornea Stem Cells in Patients Suffering From Corneal Stem Cell Insufficiency
A Phase 1 study testing Transplant of cultured limbal stem cells on cornea in people with Unilateral Limbal Stem Cell Insufficiency, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Name of the project：The application of cornea stem cells cultured on amniotic membrane in patients suffering from corneal stem cell insufficiency Purpose: To develop the technique of using ex vivo expansion of autologous limbal stem cell cultured on amniotic membrane for treatment of patients suffering from limbal… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Unilateral Limbal Stem Cell Insufficiency
- What is being tested?
- Transplant of cultured limbal stem cells on cornea
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2008to Apr 2010
- Phase
- Phase 1
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- unilateral limbus defect larger than 180 degrees
- repeated corneal epithelial ulcer, loss of visual acuity or neovascularization due to limbal stem cell insufficiency
- no improvement after medical intervention for more than 6 months
- the patient is willing to receive surgery and postoperative follow up
Who cannot join
- bilateral limbus defect
- limbal stem cell insufficiency does not induce repeated corneal epithelial ulcer, loss of visual acuity or neovascularization
- corneal neovascularization deeper than 1/2 depth of surface matrix
- peripheral surface matrix is less than 200um thick
- no corneal reflex was induced by fiber less than 5mm length measured by Cocet-Bonnet esthesiometer
- improvement under medication
Show all 14Show fewer
- perisurgical follow up less than 6 months
- unable to be long term followed up postoperatively
- glaucoma patients underwent glaucoma surgery, under medication, IOP > 21mmHg
- glaucoma patients underwent glaucoma surgery, under medication, IOP < 21mmHg, optic disc depression > 90%
- severe incomplete eyelid closure
- severe dye eye syndrome, Schirmer test 5 min < 3 mm
- contralateral eye limbus tissue cannot be obtained, or unable to be cultured
- pregnant
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital, department of Ophthalmology
Taipei, 10047
About this study
Official title: Phase 1 Study of Cornea Stem Cells Cultured on Amniotic Membrane Transplanted on Patients Suffering From Corneal Stem Cell Insufficiency
Name of the project：The application of cornea stem cells cultured on amniotic membrane in patients suffering from corneal stem cell insufficiency
Purpose: To develop the technique of using ex vivo expansion of autologous limbal stem cell cultured on amniotic membrane for treatment of patients suffering from limbal stem cell insufficiency
Read the detailed description
Materials and Methods:
- Patients suffering from unilateral limbal stem cell insufficiency will be chosen. Make sure those volunteers understand the benefits and risk factors of the operation.
- Prepare human amniotic membrane, and culture the membrane at37°C，5% CO2，95% room air.
- One month before transplantation, take 1-2mm2 of limbal tissues from the healthy eye, and culture the limbal tissue on amniotic membrane with 1.5 ml supplemental hormonal epithelial medium (in 5%的 fetal calf serum)
- Keep culturing the cells in Dulbecco's modified Eagle's medium/Ham's F12 (1:1 ratio), added with 5 % dimethyl sulfoxide, 2 mg/ml human epidermal growth factor ,5 ug/ml insulin, 0.5 ug/ml hydrocortisone, 50 ug/ml gentamicin, 1.25 ug/ml amphotericin B, 5% autoserum。Two to three weeks later, transplantation will be performed after the cells reaches 2-3 cm2
- Remove the abnormal surface tissue on the lesion cornea, transplant the amniotic membrane with cultured limbal stem cells on the denuded cornea. Cover with contact lens after operation, and apply topical antibiotics and steroids.
- Postoperatively, observe the patients for one week. After discharge, follow up the patients one week, two week, one month, two months, three months, six months and one year later.
- Pictures will be taken and the extent of corneal epithelium regeneration, visual acuity, and complications will be recorded during follow-up visits.
- The investigators plan to collect 20 patients from 1 July,2007 to 30, June, 2010
- Being tested
- Transplant of cultured limbal stem cells on cornea
- Keywords
- limbal stem cell, amniotic membrane, ex vivo expansion of autologous limbal stem cell, unilateral limbal stem cell insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transplant of cultured limbal stem cells on corneaProcedure or surgery
Remove the abnormal surface tissue on the lesion cornea, transplant the amniotic membrane with cultured limbal stem cells on the denuded cornea. Cover with contact lens after operation, and apply topical antibiotics and steroids.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients suffering from unilateral limbal stem cell insufficiency. Remove the abnormal surface tissue on the lesion cornea, transplant the amniotic membrane with cultured limbal stem cells on the denuded cornea. Cover with contact lens after operation, and apply topical antibiotics and steroids. Receives: Procedure: Transplant of cultured limbal stem cells on cornea |
What is being measured
The primary outcome is the main question the study is designed to answer.
The extent of corneal epithelium regeneration
Measured: one week, two week, one month, two months, three months, six months and one year later
Secondary outcomes (2)
visual acuity
Measured: one week, two week, one month, two months, three months, six months and one year later
complications
Measured: one week, two week, one month, two months, three months, six months and one year later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2011 (estimated)
- Study startJul 2008
- Primary completionApr 2010
- Study completionApr 2010
Why it stopped: We didn't use this tech in patient.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Limbal Stem Cell InsufficiencyStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Wei-Li Chen, MD, PhD, Principal investigator, National Taiwan University Hospital, department of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01377311
- Sponsor's protocol ID
- 32MD02
- Status last verified
- Jun 2011
- First submitted
- 21 Apr 2011
- Last updated
- 21 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Cornea Stem Cells Cultured on Amniotic Membrane Transplanted on Patients Suffering From Corneal Stem Cell Insufficiency
- ClinicalTrials.gov ID
- NCT01377311
- Acronym / sponsor ID
- 32MD02
- Keywords
- limbal stem cell, amniotic membrane, ex vivo expansion of autologous limbal stem cell, unilateral limbal stem cell insufficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We didn't use this tech in patient.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 21 Jun 2011 (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.
Name of the project：The application of cornea stem cells cultured on amniotic membrane in patients suffering from corneal stem cell insufficiency
Purpose: To develop the technique of using ex vivo expansion of autologous limbal stem cell cultured on amniotic membrane for treatment of patients suffering from limbal stem cell insufficiency
Detailed description
Materials and Methods:
- Patients suffering from unilateral limbal stem cell insufficiency will be chosen. Make sure those volunteers understand the benefits and risk factors of the operation.
- Prepare human amniotic membrane, and culture the membrane at37°C，5% CO2，95% room air.
- One month before transplantation, take 1-2mm2 of limbal tissues from the healthy eye, and culture the limbal tissue on amniotic membrane with 1.5 ml supplemental hormonal epithelial medium (in 5%的 fetal calf serum)
- Keep culturing the cells in Dulbecco's modified Eagle's medium/Ham's F12 (1:1 ratio), added with 5 % dimethyl sulfoxide, 2 mg/ml human epidermal growth factor ,5 ug/ml insulin, 0.5 ug/ml hydrocortisone, 50 ug/ml gentamicin, 1.25 ug/ml amphotericin B, 5% autoserum。Two to three weeks later, transplantation will be performed after the cells reaches 2-3 cm2
- Remove the abnormal surface tissue on the lesion cornea, transplant the amniotic membrane with cultured limbal stem cells on the denuded cornea. Cover with contact lens after operation, and apply topical antibiotics and steroids.
- Postoperatively, observe the patients for one week. After discharge, follow up the patients one week, two week, one month, two months, three months, six months and one year later.
- Pictures will be taken and the extent of corneal epithelium regeneration, visual acuity, and complications will be recorded during follow-up visits.
- The investigators plan to collect 20 patients from 1 July,2007 to 30, June, 2010
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Transplant of cultured limbal stem cells on corneaPatients suffering from unilateral limbal stem cell insufficiency. Remove the abnormal surface tissue on the lesion cornea, transplant the amniotic membrane with cultured limbal stem cells on the denuded cornea. Cover with contact lens after operation, and apply topical antibiotics and steroids. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- unilateral limbus defect larger than 180 degrees
- repeated corneal epithelial ulcer, loss of visual acuity or neovascularization due to limbal stem cell insufficiency
- no improvement after medical intervention for more than 6 months
- the patient is willing to receive surgery and postoperative follow up
Key exclusion criteria (14 listed)
- bilateral limbus defect
- limbal stem cell insufficiency does not induce repeated corneal epithelial ulcer, loss of visual acuity or neovascularization
- corneal neovascularization deeper than 1/2 depth of surface matrix
- peripheral surface matrix is less than 200um thick
- no corneal reflex was induced by fiber less than 5mm length measured by Cocet-Bonnet esthesiometer
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 |
|---|---|---|
| Transplant of cultured limbal stem cells on corneaRemove the abnormal surface tissue on the lesion cornea, transplant the amniotic membrane with cultured limbal stem cells on the denuded cornea. Cover with contact lens after operation, and apply topical antibiotics and steroids. | Procedure or surgery | 1 |
Primary outcome
The extent of corneal epithelium regeneration
Time frame: one week, two week, one month, two months, three months, six months and one year later
2 secondary outcomes
visual acuity
Time frame: one week, two week, one month, two months, three months, six months and one year later
complications
Time frame: one week, two week, one month, two months, three months, six months and one year later
Results and safety
The study was stopped early (reason given: We didn't use this tech in patient.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2011.
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, MD, PhD principal investigator
National Taiwan University Hospital, department of Ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Transplant of cultured limbal stem cells on cornea in people with Unilateral Limbal Stem Cell Insufficiency, run by National Taiwan University Hospital at 1 site 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 14 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: stopped early, as of the sponsor's last update on 21 Jun 2011. 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 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.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: We didn't use this tech in patient.). 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 extent of corneal epithelium regeneration (time frame: one week, two week, one month, two months, three months, six months and one year later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jun 2011.