Clinical trial NCT01123044: Transplantation of Cultivated Corneal Epithelial Sheet in Patients With Ocular Surface Disease
Official title: Transplantation of Cultivated Corneal Epithelial Sheet in Patients With Ocular Surface Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Eye Injury
Lead sponsor: Ministry of Health, Malaysia
Sponsor class: OTHER_GOV
First posted: 2010-05-14
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to assess if transplantation of cultivated corneal epithelial stem cells could restore vision in patients with severe ocular surface disorder with a favourable safety profile that warrants further comparative study.

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.

Eligibility criteria: Inclusion Criteria:

1. Male or non-pregnant females between 18 and 75 years of age.
2. Written informed consent obtained from patient or parents/guardian.
3. 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
4. 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:

1. 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.
2. 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.
3. Those persons directly involved in the conduct of the study.
4. Any history of severe infection such as hepatitis, renal, gastrointestinal, endocrine or neurological disease.
5. Evidence of corneal stromal scarring, cataract, macular oedema or scarring, retinal detachment and conjunctival keratinisation
6. Positive for HIV, Hepatitis B, C and VDRL
7. History of Pulmonary tuberculosis, hepatitis B,
8. History of alcohol or substance abuse
9. History of malignancy within previous 5 years
10. History of organ transplant
11. 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.

Primary outcomes:
measure: Improvement of vision at one week
timeFrame: One week
measure: Improvement of vision at one month
timeFrame: One month
measure: Improvement of vision at three month
timeFrame: Three month
measure: Improvement of vision at six month
timeFrame: Six month
measure: Improvement of vision at nine month
timeFrame: Nine month
measure: Improvement of vision at twelve month
timeFrame: Twelve month
Secondary outcomes:
measure: Adverse events reporting, vital signs, and physical examinations.
measure: Maintenance of corneal re-epithelisation with absence of recurrence of surface disease
measure: Subjective improvement of symptoms
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
state: Wilayah Persekutuan
Study officials:
References: