Cultivated Stem Cell Transplantation for the Treatment of Limbal Stem Cell Deficiency

Phase 1

• Conditions: Limbal Stem Cell Deficiency
• Interventions: Procedure: Cultivated limbal stem cell graft transplantation

• Registration Number: NCT00845117
• Lead Sponsor: Ethisch Comité UZ Antwerpen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2009-02-17
• Study First Submitted QC: 2009-02-17
• Study First Posted: 2009-02-18
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-19
• Last Update Posted: 2013-06-20
• Primary Completion: 2014-06
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 21

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Limbal Stem Cell Transplant	Cultivated limbal stem cell graft transplantation	The cornea is debrided of all superficial fibrovascular tissue and the cultivated stem cell graft is glued onto the cornea.

Primary Outcome Measures

Name	Time	Method
Visual Acuity	Just before surgery and upto 1 years after surgery
Vascularization	Just before surgery and upto 1 years after surgery
Epithelialization	Just before surgery and upto 1 years after surgery
Conjunctivalization	Just before surgery and upto 1 years after surgery

Secondary Outcome Measures

Name	Time	Method
Prolonged subsequent corneal graft survival time	1 year post corneal transplant

Trial Locations

Locations (1)

University Hospital Antwerp; 🇧🇪 Antwerp, Edegem, Belgium