Status:
UNKNOWN
Cultivated Stem Cell Transplantation for the Treatment of Limbal Stem Cell Deficiency
Lead Sponsor:
Ethisch Comité UZ Antwerpen
Collaborating Sponsors:
Fund for Scientific Research, Flanders, Belgium
European Society of Cataract and Refractive Surgeons
Conditions:
Limbal Stem Cell Deficiency
Eligibility:
All Genders
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine whether cultivated stem cell transplantation is effective for the treatment of patients wtih corneal stem cell deficiency.
Eligibility Criteria
Inclusion
- Patients suffering from LSCD IIa and IIb. Those suffering from IIc may be included once inflammation has subsided and cornea can be staged as IIb.
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
- Women of child-bearing potential should use adequate contraception prior to study entry and for the duration of study participation
Exclusion
- Subjects who are pregnant or lactating
- Subjects who have sensitivity to drugs that provide local anesthesia
- Subjects suffering from active infection of the external eye
- Medical conditions that prohibit the use of systemic immunosuppression (in cases of allogenic transplantation)
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00845117
Start Date
July 1 2008
End Date
June 1 2014
Last Update
June 20 2013
Active Locations (1)
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1
University Hospital Antwerp
Antwerp, Edegem, Belgium, 2650