- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01123044
Transplantation of Cultivated Corneal Epithelial Sheet in Patients With Ocular Surface Disease (CLET)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Objectives:
Efficacy:
To determine the efficacy of cultivated corneal epithelial stem cells as a treatment for patients with severe ocular surface disorder.
The corneal limbal epithelial stem cell transplant (CLET) successful outcome will be measured by improvement of vision, maintenance of corneal re-epithelisation with absence of recurrence of surface disease and subjective improvement of symptoms.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Wilayah Persekutuan
-
Kuala Lumpur, Wilayah Persekutuan, Malaysia, 50586
- Hospital Kuala Lumpur
-
Contact:
- Umapathy
- Email: thiagesw@yahoo.com
-
Principal Investigator:
- Thiages Umapathy, Dr.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or non-pregnant females between 18 and 75 years of age.
- Written informed consent obtained from patient or parents/guardian.
Patients with unilateral limbal stem deficiency 2-12 months presenting with any of the following
- Conjunctivalisation
- Absence of limbal palisades of Vogts
- Chronic inflammation
- Persistent or recurrent corneal epithelial defect
Patients who had 2-12 months of conservative treatment. * Diagnostic criteria for limbal stem cell deficiency are as follows:
- Symptoms of decreased vision, redness, watering, photophobia and recurrent attacks of pain
- Triad of signs: conjunctivalisation, neovascularisation and chronic inflammation
- Stippled appearance of cunjunctivalised cornea with loss of palisades of Vogt
- Recurrent and persistent epithelial defects
- Superficial vascularisation, scarring, thick fibrovascular pannus, ulceration, melting and perforation
Exclusion Criteria:
Patients with any of the following are not eligible for enrollment into the study:
- Pregnant or nursing woman or women of childbearing potential except if post-menopausal, surgically sterile or using accepted method(s) of birth control or having negative pregnancy test.
- Participation in any drug trial in which the patient received an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the screening phase of this study.
- Those persons directly involved in the conduct of the study.
- Any history of severe infection such as hepatitis, renal, gastrointestinal, endocrine or neurological disease.
- Evidence of corneal stromal scarring, cataract, macular oedema or scarring, retinal detachment and conjunctival keratinisation
- Positive for HIV, Hepatitis B, C and VDRL
- History of Pulmonary tuberculosis, hepatitis B,
- History of alcohol or substance abuse
- History of malignancy within previous 5 years
- History of organ transplant
- Any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: corneal stem cell transplant
|
Undergo autologous transplantation of limbal epithelial cells cultured on amniotic membrane
|
NO_INTERVENTION: conservative medical therapy
|
Undergo autologous transplantation of limbal epithelial cells cultured on amniotic membrane
Under usual care treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement of vision at one week
Time Frame: One week
|
The primary efficacy variable will be improved visual acuity Vision will be assessed using ETDRS logMAR visual acuity measurements.
An improvement of > 1 line
|
One week
|
Improvement of vision at one month
Time Frame: One month
|
The primary efficacy variable will be improved visual acuity Vision will be assessed using ETDRS logMAR visual acuity measurements.
An improvement of > 1 line
|
One month
|
Improvement of vision at three month
Time Frame: Three month
|
The primary efficacy variable will be improved visual acuity Vision will be assessed using ETDRS logMAR visual acuity measurements.
An improvement of > 1 line
|
Three month
|
Improvement of vision at six month
Time Frame: Six month
|
The primary efficacy variable will be improved visual acuity Vision will be assessed using ETDRS logMAR visual acuity measurements.
An improvement of > 1 line
|
Six month
|
Improvement of vision at nine month
Time Frame: Nine month
|
The primary efficacy variable will be improved visual acuity Vision will be assessed using ETDRS logMAR visual acuity measurements.
An improvement of > 1 line
|
Nine month
|
Improvement of vision at twelve month
Time Frame: Twelve month
|
The primary efficacy variable will be improved visual acuity Vision will be assessed using ETDRS logMAR visual acuity measurements.
An improvement of > 1 line
|
Twelve month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
---|---|
Adverse events reporting, vital signs, and physical examinations.
|
To evaluate the safety and tolerability of transplantation of limbal epithelial cells cultured on amniotic membrane for a follow-up period of one year in patients.
Safety will be evaluated using adverse events reporting, vital signs, and physical examinations.
|
Maintenance of corneal re-epithelisation with absence of recurrence of surface disease
|
|
Subjective improvement of symptoms
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CT 09-01
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