Ignite Creation Date:
2024-05-06 @ 10:31 AM
Last Modification Date:
2024-10-26 @ 12:32 PM
Study NCT ID:
NCT03288844
Status:
COMPLETED
Last Update Posted:
2023-05-26
First Post:
2017-09-18
Brief Title:
Follow-up Study After ACLSCT for Restoration of Corneal Epithelium in Patients With LSCD Due to Ocular Burns
Sponsor:
Holostem Terapie Avanzate srl
Organization:
Holostem Terapie Avanzate srl
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HOLOCORE-FU
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2015-001344-11 | EUDRACT_NUMBER | None | None |