CompletedPhase 1ACTRN12607000211460

Epithelial cell transfer for severe corneal disease

To improve the success in ocular surface reconstruction, with an autologous ocular surface epithelial transfer technique for patients suffering corneal stem cell deficiency diseases using therapeutic contact lenses as the carrier


Sponsor

Inflammatory Diseases Research Unit, School of Medical Sciences, University of NSW

Enrollment

30 participants

Start Date

Oct 29, 2007

Study Type

Interventional

Conditions

Summary

We have developed a unique transfer technique which utilizes cells cultured on a therapeutic contact lens and propose that this may be a potentially novel treatment strategy for patients suffering severe corneal disease where corneal epithelial wound healing is not properly regulated, possibly as a consequence of stem cell damage, stem cell failure or stem cell depletion. Currently, patients are treated by grafting foreign or autologous stem cells that are cultured in the presence of animal products or by using techniques which involve growing ocular stem cells on amniotic membrane (foreign biological material) then transferring these cells along with the amniotic membrane to the damaged cornea. Our proposed system would be entirely autologous.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether transplanting epithelial cells can help treat severe corneal disease and restore vision. This study is open to both men and women aged 18 and older. Participation involves a cell transplant procedure followed by regular eye examinations to track healing and vision improvement.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

A limbal tissue biopsy will be harvested from patients suffering unilateral or bilateral limbal stem cells deficiency diseases and placed in tissue culture on a therapeutic contact lenses (Lotrafilcon

A limbal tissue biopsy will be harvested from patients suffering unilateral or bilateral limbal stem cells deficiency diseases and placed in tissue culture on a therapeutic contact lenses (Lotrafilcon A or B; CIBA Vision) in the presence of autologous serum. The cell loaded contact lens will then be placed over the defected eye to allow cell s to be transfered. The device (contact lenses) will remain on the ocular surface for no longer than 21-days. The ocular surface will be reviewed regularly for corneal epithelial reconstruction particularly over the first 6-months. If after one year, the epithelium is healthy and stable, patients will be reviewed at less regular intervals over the next 2-years.


Locations(1)

Australia

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ACTRN12607000211460