None listed
Conditions
Brief 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.
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 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
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.
Sponsors
Inflammatory Diseases Research Unit, School of Medical Sciences, University of NSW
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients with limbal stem cell deficiency diseases* patients capable of giving written informed consent and complying with the study protocol.
Exclusion criteria
* patients with corneal perforationpatients with autoimmune disease (e.g rheumatoid arthritis, MOoren's ulcer, lupus etc)*active bacterial, fungal, or amoebic ulcers*vitamin A deficiency* pregnant or lactating women* viral infections.
Outcome results
None listed