Transplantation of Cultivated Corneal Epithelial Sheet in Patients With Ocular Surface Disease

NCT ID: NCT01123044

Last Updated: 2011-07-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2012-09-30

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.

Conditions

Eye Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

corneal stem cell transplant

Group Type: EXPERIMENTAL

conservative

Intervention Type: BIOLOGICAL

Undergo autologous transplantation of limbal epithelial cells cultured on amniotic membrane

conservative medical therapy

Group Type: NO_INTERVENTION

conservative

Intervention Type: BIOLOGICAL

Undergo autologous transplantation of limbal epithelial cells cultured on amniotic membrane

Medical Therapy

Intervention Type: PROCEDURE

Under usual care treatment

Interventions

conservative

Undergo autologous transplantation of limbal epithelial cells cultured on amniotic membrane

Intervention Type: BIOLOGICAL

Medical Therapy

Under usual care treatment

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Malaysia

OTHER_GOV

Sponsor Role: lead

Responsible Party

Clinical Research Centre

Locations

Hospital Kuala Lumpur

Kuala Lumpur, Kuala Lumpur, Malaysia

Countries

Malaysia

Facility Contacts

Umapathy

Role: primary

thiagesw@yahoo.com

Other Identifiers

CT 09-01

Identifier Type: -

Identifier Source: org_study_id