ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12607000211460

Ethics application status

Approved

Date submitted

13/04/2007

Date registered

17/04/2007

Date last updated

15/11/2019

Date data sharing statement initially provided

15/11/2019

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

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Limbal stem cells deficiency

Condition category

Condition code

Eye

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]

Treatment: Devices

Comparator / control treatment

No comparator.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

A stable and healthy corneal epithelium. Indicators of a healthy cornea may include healing of a corneal ulcer or inhibition of conjunctivilisation.

Timepoint [1]

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]

Corneal epithelial integrity and re-surfacing.

Timepoint [1]

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

Sex

Both males and females

Can healthy volunteers participate?

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

Completed

Date of first participant enrolment

Anticipated

1/05/2007

Actual

29/10/2007

Date of last participant enrolment

Anticipated

Actual

27/09/2011

Date of last data collection

Anticipated

Actual

17/06/2013

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

University

Name [1]

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

Address [1]

Sydney 2052 NSW

Country [1]

Australia

Primary sponsor type

University

Name

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

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

none

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

UNSW

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/12/2006

Approval date [1]

26/03/2007

Ethics approval number [1]

06290

Ethics committee name [2]

SESAHS

Ethics committee address [2]

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

14/03/2007

Approval date [2]

16/03/2007

Ethics approval number [2]

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

Talks
1.	A contact lens-based technique for ocular surface reconstruction. 2nd Annual Stem Cells Symposium at UNSW. 28th Nov POWH, Sydney.
2.	A novel stem cell transplantation strategy to treat LSCD. Association for Research in Vision and Ophthalmology (ARVO). Special Interest Group. Ft Lauderdale, FL, USA 2-7th May 2009
3.	Stem cell transplantation for corneal blindness. UNSW, Sydney, Australia. 24-08-2009
4.	Stem cell therapy for corneal blindness. NSW Stem Cell Network Annual Symposium, Prince of Wales Hospital. 07-12-2009
5.	A contact lens-based technique for expansion and transplantation of autologous epithelial progenitors for ocular surface reconstruction. Australian Stem Cell Centre. Feb 3-5 2010, Kingscliff, Queensland, Australia
6.	Corneal stem cell transplantation. Veneto Eye Bank, Venice, Italy 08-06-2010
7.	Isolation and transplantation strategies for corneal stem cells. “Form and Function in Ocular Diseases Symposium”, Dalhousie University, Halifax, Canada. 02-10-2010
8.	Tissue-regenerating, vision-restoring corneal epithelial stem cells. Sydney University Australia. 10-11-2010
Published Papers
1.	Di Girolamo N, Watson S. Contact lens-based technique for expansion and transplantation of autologous epithelial progenitors for ocular surface reconstruction: crossover control. Transplantation. 2010;89(4):484-484.
2.	Bobba S, Chow S, Watson S, Di Girolamo N. Clinical outcomes of xeno-free expansion and transplantation of autologous ocular surface epithelial stem cells via contact lens delivery: a prospective case series. Stem Cell Res Therapy. 2015;6:23.
3.	Bobba S, Watson S, Di Girolamo N. Contact lens delivery of stem cells for restoring the ocular surface. (Chapter 9) In Biomaterials and Regenerative Medicine in Ophthalmology. 2nd Edition. Pp 219-239. Eds Traian Chirila and Damian Harkin. Woodhead Publishing, Sydney, 2016 ISBN9781845694432.
4.	Bobba S, Di Girolamo N. Contact lenses: a delivery device for stem cells to treat corneal blindness. Optom Vis Sci. 2016;93:412-418.

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Nick Di Girolamo

Address

Inflammatory Diseases Research Unit
School of Medical Sciences
University of NSW
High Street
Kensington NSW 2052

Country

Australia

Phone

+61 2 93852538

Fax

+61 2 93851389

n.digirolamo@unsw.edu.au

Contact person for scientific queries

Name

Dr Nick Di Girolamo

Address

Inflammatory Diseases Research Unit
School of Medical Sciences
University of NSW
High Street
Kensington NSW 2052

Country

Australia

Phone

+61 2 93852538

Fax

+61 2 93851389

n.digirolamo@unsw.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Cultured limbal tissue transplants	2012	https://doi.org/10.1111/j.1442-9071.2012.02877.x

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically