Multinational, Multicenter, 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

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

Sponsors

Lead sponsor: Chiesi Farmaceutici S.p.A.

Collaborator: Cromsource

Source Chiesi Farmaceutici S.p.A.
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.

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 main HOLOCORE interventional clinical trial) is suspected to improve the success of keratoplasty in those patients candidate to receive this treatment but no data were collected in the three previous retrospective studies (HLSTM01, HLSTM02 and HLSTM04) on Holoclar, this follow-up study has been thought to observe the progress of the disease and to collect data on keratoplasty and evaluate the benefits of Holoclar in subsequent keratoplasty in patients treated once or two times with Holoclar.

All patients treated in the HOLOCORE clinical trial who consent to roll over to the present extension study at the end of the HOLOCORE will be observed for a follow-up period which may vary from a minimum of 12 month for the last patient to a maximum of 57 months for the first patient entered.

A total of approximately 70 patients is expected (all patients who completed the HOLOCORE study).

In case the last enrolled patient undergoes to Keratoplasty at the Last Visit of the Follow-up study, this will consequently lead to a prolongation of the study up to further 12 months for all patients.

The subjects will be enrolled and observed at the same investigational centers where they were recruited for the HOLOCORE clinical trial.

No drug will be administered for the scope of this study. Ophtalmological visits including pictures collection and quality of life evaluations will be performed every 6 months.

Overall Status Recruiting
Start Date December 13, 2017
Completion Date December 2021
Primary Completion Date December 2021
Study Type Observational
Primary Outcome
Measure Time Frame
Success of transplantation 1 year
Enrollment 70
Condition
Intervention

Intervention type: Procedure

Intervention name: Ophthalmologic examinations

Description: 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.

Arm group label: HOLOCORE Patients

Intervention type: Other

Intervention name: Digital pictures

Description: Digital pictures 2D to be taken at each visit

Arm group label: HOLOCORE Patients

Intervention type: Other

Intervention name: QoL Questionnaires

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

Arm group label: HOLOCORE Patients

Eligibility

Sampling method: Non-Probability Sample

Criteria:

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.

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Paolo Rama, MD Principal Investigator San Raffaele Hospital
Overall Contact

Last name: Clinical Trial Info

Phone: +39.0521 2791

Email: [email protected]

Location
facility status contact
Hospital San Raffaele Recruiting Paolo Rama, MD
Location Countries

Italy

Verification Date

February 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: HOLOCORE Patients

Description: 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

Acronym HOLOCORE-FU
Patient Data Undecided
Study Design Info

Observational model: Case-Only

Time perspective: Prospective

Source: ClinicalTrials.gov