Status:
COMPLETED
Follow-up Study After ACLSCT for Restoration of Corneal Epithelium in Patients With LSCD Due to Ocular Burns
Lead Sponsor:
Holostem s.r.l.
Collaborating Sponsors:
Cromsource
Conditions:
Limbal Stem Cell Deficiency Due to Ocular Burn
Eligibility:
All Genders
Brief Summary
This is a multinational, multicentre, prospective, non-pharmacological follow-up study of the clinical trial HOLOCORE. All patients transplanted with Holoclar in the HOLOCORE clinical trial who consen...
Detailed Description
HOLOCORE FOLLOW-UP prospective study offers the opportunity to collect long-term efficacy and safety data after one or two treatments with Holoclar. Moreover, since Holoclar (study drug used in the ma...
Eligibility Criteria
Inclusion
- All patients (adults and pediatrics) 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
- No specific exclusion criterion is considered for this study, except for patients dropping out from the HOLOCORE study or withdrawing consent.
Key Trial Info
Start Date :
December 13 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2023
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT03288844
Start Date
December 13 2017
End Date
March 31 2023
Last Update
May 26 2023
Active Locations (1)
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1
Hospital San Raffaele
Milan, Italy, 20100