Limbal Stem Cell Deficiency Clinical Trial
— LECTOfficial title:
Cultivated Stem Cell Transplantation for the Treatment of Limbal Stem Cell Deficiency
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.
Status | Active, not recruiting |
Enrollment | 21 |
Est. completion date | June 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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) |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | University Hospital Antwerp | Antwerp | Edegem |
Lead Sponsor | Collaborator |
---|---|
Ethisch Comité UZ Antwerpen | Agentschap voor Innovatie door Wetenschap en Technologie, European Society of Cataract and Refractive Surgeons, Fund for Scientific Research, Flanders, Belgium |
Belgium,
Zakaria N, Koppen C, Van Tendeloo V, Berneman Z, Hopkinson A, Tassignon MJ. Standardized limbal epithelial stem cell graft generation and transplantation. Tissue Eng Part C Methods. 2010 Oct;16(5):921-7. doi: 10.1089/ten.TEC.2009.0634. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual Acuity | Just before surgery and upto 1 years after surgery | Yes | |
Primary | Conjunctivalization | Just before surgery and upto 1 years after surgery | Yes | |
Primary | Vascularization | Just before surgery and upto 1 years after surgery | Yes | |
Primary | Epithelialization | Just before surgery and upto 1 years after surgery | Yes | |
Secondary | Prolonged subsequent corneal graft survival time | 1 year post corneal transplant | No |
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