Autologous ex Vivo Conjunctival Epithelial Cell Expansion for Ocular Surface Transplantation
1 other identifier
interventional
80
1 country
1
Brief Summary
To evaluate the use of cultivated conjunctival epithelial equivalents for the treatment of ocular diseases
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2001
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2003
CompletedFirst Submitted
Initial submission to the registry
June 29, 2006
CompletedFirst Posted
Study publicly available on registry
June 30, 2006
CompletedJanuary 13, 2010
January 1, 2010
June 29, 2006
January 11, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Epithelialisation
Graft integrity
Resolution of inflammation
Visual acuity
Complications
Secondary Outcomes (1)
Degree of scarring
Interventions
Eligibility Criteria
You may qualify if:
- Patients with ocular surface disorders, e.g. primary pterygium, scheduled for elective surgical excision
- Indications for surgery will be the presence of ocular surface symptoms in the affected eye, loss of visual acuity from visual axis obscuration or irregular astigmatism, or cosmesis.
- Only one eye of a patient will be eligible for study entry.
- Patients who are adult males and females who are aged 21 or older, and are considered mentally sound
- Patients who are willing to undergo long-term follow-up, as outlined in this protocol
- Patients who have signed an informed consent form that has been approved by the SNEC Ethics Committee.
You may not qualify if:
- Patients less than 21 years of age
- Patients who are incapable, either by law or of mental state, of giving consent in their own right
- Patients who are either unable or unwilling to keep scheduled appointments and adhere to the other aspects of the protocol
- Patients who are pregnant or breastfeeding
- Patients with a history of drug allergy
- Patients who have received an investigational drug within 28 days preceding surgery
- Patients with intraocular pressure over 21 mmHg or history of ocular hypertension or glaucoma
- Patients who are documented to be steroid responders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Singapore National Eye Centrelead
- International Stem Cell Forumcollaborator
- National Medical Research Council (NMRC), Singaporecollaborator
- Singapore Eye Research Institutecollaborator
Study Sites (1)
Singapore National Eye Centre
Singapore, 168751, Singapore
Related Publications (2)
Ang LP, Tan DT, Beuerman RW, Lavker RM. Development of a conjunctival epithelial equivalent with improved proliferative properties using a multistep serum-free culture system. Invest Ophthalmol Vis Sci. 2004 Jun;45(6):1789-95. doi: 10.1167/iovs.03-1361.
PMID: 15161841RESULTAng LP, Tan DT, Phan TT, Li J, Beuerman R, Lavker RM. The in vitro and in vivo proliferative capacity of serum-free cultivated human conjunctival epithelial cells. Curr Eye Res. 2004 May;28(5):307-17. doi: 10.1076/ceyr.28.5.307.28677.
PMID: 15287367RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leonard P Ang, FRCS
SNEC, NUS
- PRINCIPAL INVESTIGATOR
Donald T Tan, FRCS
SNEC, SERI, NUS
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
June 29, 2006
First Posted
June 30, 2006
Study Start
October 1, 2001
Study Completion
December 1, 2003
Last Updated
January 13, 2010
Record last verified: 2010-01