Ignite Creation Date:
2024-05-06 @ 7:38 AM
Last Modification Date:
2024-10-26 @ 11:51 AM
Study NCT ID:
NCT02577861
Status:
COMPLETED
Last Update Posted:
2022-04-01
First Post:
2015-10-15
Brief Title:
Efficacy and Safety of Autologous Cultivated Limbal Stem Cells Transplantation ACLSCT for Restoration of Corneal Epithelium in Patients With Limbal Stem Cell Deficiency
Sponsor:
Holostem Terapie Avanzate srl
Organization:
Holostem Terapie Avanzate srl
Study Overview
Official Title:
Multinational Multicentre Prospective Open-label Uncontrolled Clinical Trial to Assess the Efficacy and Safety of Autologous Cultivated Limbal Stem Cells Transplantation ACLSCT for Restoration of Corneal Epithelium in Patients With Limbal Stem Cell Deficiency Due to Ocular Burns HOLOCORE
Status:
COMPLETED
Status Verified Date:
2022-03
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
Brief Summary:
The purpose of this trial is to confirm the efficacy of Holoclar at one year after the first treatment in patients suffering from moderate to severe LSCD Limbal Stem Cell Deficiency secondary to ocular burns In case of failure of the treatment and upon clinical indication of the Principal Investigator a second transplant with Holoclar will be offered if eligibility will be confirmed The efficacy of two treatments with Holoclar at one year after the last treatment will be also evaluated All patients will be followed-up for 12 months after each implant to determine the treatment efficacy by an Independent Assessor
Detailed Description:
This is a multinational multicentre prospective open label uncontrolled clinical trial
Patients will be screened according to the Study Inclusion and Exclusion criteria and will be candidates for the ACLSCT if all eligibility criteria are met
Patients then will undergo limbal biopsy for the collection of limbal stem cells for product manufacturing The confirmation of the eligibility criteria is followed by a roll-in phase of approximately 6 months At the end of the roll-in period Holoclar will be implanted through a specific surgical procedure
After ACLSCT efficacy assessments will be performed at 1 3 6 9 and 12 months for both first and second treatment the latter only when applicable One year after the transplantation efficacy will be adjudicated by two independent assessors primary and key secondary endpoints and the study completion will be reached when 1 year of follow-up after the last transplant in the last patient will be accomplished
Patients will be screened according to the Study Inclusion and Exclusion criteria and will be candidates for the ACLSCT if all eligibility criteria are met
Patients then will undergo limbal biopsy for the collection of limbal stem cells for product manufacturing The confirmation of the eligibility criteria is followed by a roll-in phase of approximately 6 months At the end of the roll-in period Holoclar will be implanted through a specific surgical procedure
After ACLSCT efficacy assessments will be performed at 1 3 6 9 and 12 months for both first and second treatment the latter only when applicable One year after the transplantation efficacy will be adjudicated by two independent assessors primary and key secondary endpoints and the study completion will be reached when 1 year of follow-up after the last transplant in the last patient will be accomplished
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| 2014-002845-23 | EUDRACT_NUMBER | None | None |