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Sponsors and Collaborators: |
Singapore National Eye Centre Biomedical Research Council National Medical Research Council Singapore Eye Research Institute |
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Information provided by: | Singapore National Eye Centre |
ClinicalTrials.gov Identifier: | NCT00346450 |
To evaluate the use of cultivated conjunctival epithelial equivalents for the treatment of ocular diseases
Condition | Intervention | Phase |
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Pterygium Ocular Surface Disease Stevens Johnson Syndrome Chemical Injury |
Procedure: Cultivated conjunctival transplantation |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Autologous Ex Vivo Conjunctival Epithelial Cell Expansion for Ocular Surface |
Estimated Enrollment: | 80 |
Study Start Date: | October 2001 |
Estimated Study Completion Date: | December 2009 |
Ex-vivo autologous conjunctiva expansion on human amniotic membrane (HAM), followed by clinical transplantation surgery
Preparation of HAM. Human amniotic membrane (HAM) prepared for human use will be obtained from the Singapore Eye Bank. HAM will be rapidly thawed in a 37oC water bath, and washed with phosphate buffered saline. The amniotic epithelium will be removed using a combination of Dispase digestion and mechanical scraping. Complete removal of the amniotic epithelial cells will be confirmed by microscopy. The HAM is then placed on a culture plate, with the basement-membrane side up, and incubated with DMEM at 37oC in an atmosphere of 5% CO2 and 95% air overnight before use.
Ex-vivo expansion of conjunctival cells on HAM. A forniceal conjunctival biopsy will be performed in patients undergoing pterygium surgery. The tissue will be cultured on the HAM either as a cell suspension or as explants, with the methods described above. The media is changed every 2 days and the culture is maintained for 2-3 weeks. The cells will form a confluent sheet and begin to stratify and differentiate. The tissue will then be raised to an air-liquid interface to promote differentiation.
Histological analysis. The conjunctival epithelial cell sheets on the amniotic membrane will be examined by light microscopy. Samples of the tissue will be fixed and processed with the use of standard histological procedures and stained with H&E and PAS reagents. Electron microscopic examination will be carried for the tissue. The sections will also be subjected to immunohistochemical analysis for cytokeratin markers.
Clinical Transplantation of cultivated conjunctival epithelial cells on HAM
Preparation of cultivated conjunctival cells on amniotic membrane Patients with various ocular surface disorders will be selected for the initial series of transplantations. All patients will undergo full counselling for informed consent for the procedures. A forniceal conjunctival biopsy will be performed on the contralateral healthy eye. PI will perform the transplantations of autologous conjunctival sheet grown on human amniotic membrane in these patients. The diseased area will be excised using the standard surgical technique. The defect will be covered with the sheet of cultured conjunctival cells on the HAM with the epithelial side up. The graft is secured to the adjacent conjunctiva with interrupted 8/0 vicryl sutures. A planotherapeutic bandage contact lens is placed to protect the tissue from lid trauma. Topical steroid and antibiotic eyedrops will be administered daily to reduce the ocular inflammation. Survival of conjunctiva on the amniotic membrane will be closely monitored and patients will be followed-up at 3 monthly intervals up to one year. During these visits, these patients will have anterior segment photographs taken and fluorescein staining to monitor the progress of healing.
Transplantations may also be carried out on selected patients with ocular surface disease, for example, ocular cicatricial pemphigoid, Stevens Johnson syndrome and alkali injury. For these severe conditions, this procedure may prove to be an important adjunct to other procedures, such as limbal stem cell transplantation. If the initial study is successful, a randomised clinical trial comparing this procedure with conventional conjunctival autografting and conventional amniotic membrane transplantation will be planned. Therefore if found to be successful, transplantation of cultured conjunctival cells on HAM may eventually be used as a primary procedure or as an adjunctive procedure for these visually debilitating conditions.
Ages Eligible for Study: | 21 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Leonard P Ang, FRCS | 65-98430823 | leopk@pacific.net.sg |
Contact: Donald T Tan, FRCS | 65-63228333 | snecdt@pacific.net.sg |
Singapore | |
Singapore National Eye Centre | Recruiting |
Singapore, Singapore, 168751 | |
Contact: Leonard P Ang, FRCS 65-98430823 leopk@pacific.net.sg | |
Contact: Donald T Tan, FRCS 65-63228333 snecdt@pacific.net.sg | |
Principal Investigator: Leonard P Ang, FRCS | |
Principal Investigator: Donald T Tan, FRCS | |
Sub-Investigator: Roger Beuerman, PhD | |
Sub-Investigator: Phuc T Do, MD |
Principal Investigator: | Leonard P Ang, FRCS | SNEC, NUS |
Principal Investigator: | Donald T Tan, FRCS | SNEC, SERI, NUS |
Study ID Numbers: | R198/24/2000 |
Study First Received: | June 29, 2006 |
Last Updated: | June 29, 2006 |
ClinicalTrials.gov Identifier: | NCT00346450 History of Changes |
Health Authority: | Singapore: Health Sciences Authority |
Culture Conjunctiva transplantation pterygium ocular surface |
Mouth Diseases Erythema Skin Diseases, Vesiculobullous Skin Diseases Stomatitis Eye Diseases |
Stevens-Johnson Syndrome Pterygium of the Conjunctiva Stomatognathic Diseases Pterygium Conjunctival Diseases |
Mouth Diseases Erythema Disease Stomatitis Skin Diseases Skin Diseases, Vesiculobullous Eye Diseases |
Conjunctival Diseases Pathologic Processes Syndrome Stevens-Johnson Syndrome Erythema Multiforme Stomatognathic Diseases Pterygium |