This trial is active, not recruiting.

Condition limbal stem cell deficiency
Treatment cultivated limbal stem cell graft transplantation
Phase phase 1/phase 2
Sponsor Ethisch Comité UZ Antwerpen
Collaborator Fund for Scientific Research, Flanders, Belgium
Start date July 2008
End date June 2014
Trial size 21 participants
Trial identifier NCT00845117, EC 7/28/153


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
The cornea is debrided of all superficial fibrovascular tissue and the cultivated stem cell graft is glued onto the cornea.
cultivated limbal stem cell graft transplantation
A limbal biopsy taken from the contralateral good eye in cases of unilateral disease or from a living related or cadaveric donor in cases of bilateral disease. The limbal stem cells from the biopsy are cultivated until a sheet of cells measuring approximately 12mm in diameter is obtained. This is then ready for transplantation onto the diseased eye.

Primary Outcomes

Visual Acuity
time frame: Just before surgery and upto 1 years after surgery
time frame: Just before surgery and upto 1 years after surgery
time frame: Just before surgery and upto 1 years after surgery
time frame: Just before surgery and upto 1 years after surgery

Secondary Outcomes

Prolonged subsequent corneal graft survival time
time frame: 1 year post corneal transplant

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - 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 Criteria: - 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)

Additional Information

Official title Cultivated Stem Cell Transplantation for the Treatment of Limbal Stem Cell Deficiency
Principal investigator Nadia Zakaria, MBBS, PhD
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by University Hospital, Antwerp.