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

NCT03288844 | Completed

• 2 other identifiers: CCD-GPLSCD01-03-FU2015-001344-11
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

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

Conditions

Limbal Stem Cell Deficiency Due to Ocular Burn

Keywords

LSCD, Holoclar, follow-up

Outcome Measures

Primary Outcomes (1)

• Success of transplantation

  Transplantation will be considered with a clinically-relevant success if the severity of superficial corneal neo-vascularization will be judged as not exceeding one quadrant of invasion (without central cornea involvement) by the investigator and the degree of Epithelial defect as 'None' or 'Trace', respectively.

  1 year

Study Arms (1)

HOLOCORE Patients

Patients who completed the main HOLOCORE clinical trial will undergo to Ophthalmologic examinations, Digital pictures collection and QoL questionnaires (NEI VFQ 25 and EQ-5D-3L/Y) will be performed/administered at each study visit

Procedure: Ophthalmologic examinations; Other: Digital pictures; Other: QoL Questionnaires

Interventions

Ophthalmologic examinations PROCEDURE

epithelial defects assessment by fluorescein staining; superficial corneal neo-vascularization assessment; ocular tonometry; slit lamp examination; conjunctival (both bulbar and limbal) inflammation assessment; corneal sensitivity; central cornea involvement (for opacity or central CNV); Best-Corrected Visual Acuity; evaluation of symptoms.

HOLOCORE Patients

Digital pictures OTHER

Digital pictures 2D to be taken at each visit

HOLOCORE Patients

QoL Questionnaires OTHER

Quality of Life (NEI VFQ 25 and EQ-5D-3L/Y) questionnaires will be submitted at each visit

HOLOCORE Patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All eligible patients who entered the core HOLOCORE study will be asked consent to roll over into this extension study before their inclusion. Approximately 70 patients will be enrolled in this study. Safety population: all patients entering the study. The adult safety population will be used to explore efficacy. Efficacy data collected on paediatric population will be only listed.

You may qualify if:

• 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.

Sponsors & Collaborators

• Holostem s.r.l.: lead
• Cromsource: collaborator

Study Sites (1)

Hospital San Raffaele

Milan, 20100, Italy

Location

Study Officials

• Graziella Pellegrini, Professor

  Holostem s.r.l.

  STUDY DIRECTOR

• Paolo Rama, MD

  Fondazione I.R.C.C.S. Policlinico San Matteo, Pavia, Italy

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: September 20, 2017
• Study Start: December 13, 2017
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: May 26, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)