Cultivated Stem Cell Transplantation for the Treatment of Limbal Stem Cell Deficiency
Phase 1
- Conditions
- Limbal Stem Cell Deficiency
- 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
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
- 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
University Hospital Antwerp🇧🇪Antwerp, Edegem, Belgium