MULTINATIONAL, MULTICENTRE, PROSPECTIVE, LONG-TERM SAFETY AND EFFICACY FOLLOW-UP STUDY AFTER AUTOLOGOUS CULTIVATED LIMBAL STEM CELLS TRANSPLANTATION (ACLSCT) FOR RESTORATION OF CORNEAL EPITHELIUM IN PATIENTS WITH LIMBAL STEM CELL DEFICIENCY DUE TO OCULAR BURNS
Phase 4
Completed
- Conditions
- Corneal lesions with associated moderate to severe limbal stem cell defieciency due to ocular terms10030046
- Registration Number
- NL-OMON49307
- Lead Sponsor
- Holostem Terapie Avenzate S.r.l
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 4
Inclusion Criteria
All adult patients who completed the HOLOCORE core study and who consent to
roll over to the present extension study at the end of the HOLOCORE follow-up.
Exclusion Criteria
No specific exclusion criterion is considered for this study, except for
patients dropping out from the HOLOCORE study or withdrawing consent.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method