CompletedNot Applicable

Follow-up Study After ACLSCT for Restoration of Corneal Epithelium in Patients With LSCD Due to Ocular Burns

Italy47 participantsStarted 2017-12-13

Plain-language 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 consent to participate will be enrolled in this prospective study and observed for at least 12 months.

Who can participate

SexALL

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Inclusion Criteria: * 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 Criteria: * No specific exclusion criterion is considered for this study, except for patients dropping out from the HOLOCORE study or withdrawing consent.

What they're measuring

Success of transplantation

Timeframe: 1 year

Trial details

NCT IDNCT03288844

SponsorHolostem s.r.l.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-03-31

View on ClinicalTrials.gov More Limbal Stem Cell Deficiency Due to Ocular Burn trials