Pterygium Clinical Trial
Official title:
Autologous ex Vivo Conjunctival Epithelial Cell Expansion for Ocular Surface
To evaluate the use of cultivated conjunctival epithelial equivalents for the treatment of ocular diseases
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.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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