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Trial registered on ANZCTR


Trial ID
ACTRN12607000211460
Ethics application status
Approved
Date submitted
13/04/2007
Date registered
17/04/2007
Date last updated
17/04/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Epithelial cell transfer for severe corneal disease
Scientific title
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
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Limbal stem cells deficiency 1738 0
Condition category
Condition code
Eye 1830 1830 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 1701 0
Treatment: Devices
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2561 0
A stable and healthy corneal epithelium. Indicators of a healthy cornea may include healing of a corneal ulcer or inhibition of conjunctivilisation.
Timepoint [1] 2561 0
Ocular health will be monitored twice weekly with the contact lense left over the affected eye, then weekly over the next 4-weeks, monthly over the next 6-months, then 6-monthly over the next two years.
Secondary outcome [1] 4413 0
Corneal epithelial integrity and re-surfacing.
Timepoint [1] 4413 0
Both parameters will be measured twice weekly for the first two weeks, weekly for the next 4-weeks, monthly for the next 6-months, then 6monthly for the following 2-3 years.

Eligibility
Key inclusion criteria
* patients with limbal stem cell deficiency diseases* patients capable of giving written informed consent and complying with the study protocol.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Current
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1979 0
University
Name [1] 1979 0
Inflammatory Diseases Research Unit, School of Medical Sciences, University of NSW
Address [1] 1979 0
Country [1] 1979 0
Australia
Primary sponsor type
University
Name
Inflammatory Diseases Research Unit, School of Medical Sciences, University of NSW
Address
Country
Australia
Secondary sponsor category [1] 1792 0
None
Name [1] 1792 0
none
Address [1] 1792 0
Country [1] 1792 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3676 0
UNSW
Ethics committee address [1] 3676 0
Ethics committee country [1] 3676 0
Australia
Date submitted for ethics approval [1] 3676 0
Approval date [1] 3676 0
26/03/2007
Ethics approval number [1] 3676 0
06290
Ethics committee name [2] 3677 0
SESAHS
Ethics committee address [2] 3677 0
Ethics committee country [2] 3677 0
Australia
Date submitted for ethics approval [2] 3677 0
Approval date [2] 3677 0
16/03/2007
Ethics approval number [2] 3677 0
07/025

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27804 0
Address 27804 0
Country 27804 0
Phone 27804 0
Fax 27804 0
Email 27804 0
Contact person for public queries
Name 10890 0
Dr Nick Di Girolamo
Address 10890 0
Inflammatory Diseases Research Unit
School of Medical Sciences
University of NSW
High Street
Kensington NSW 2052
Country 10890 0
Australia
Phone 10890 0
+61 2 93852538
Fax 10890 0
+61 2 93851389
Email 10890 0
n.digirolamo@unsw.edu.au
Contact person for scientific queries
Name 1818 0
Dr Nick Di Girolamo
Address 1818 0
Inflammatory Diseases Research Unit
School of Medical Sciences
University of NSW
High Street
Kensington NSW 2052
Country 1818 0
Australia
Phone 1818 0
+61 2 93852538
Fax 1818 0
+61 2 93851389
Email 1818 0
n.digirolamo@unsw.edu.au