Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-30 @ 8:41 AM
Study NCT ID:
NCT01443559
Status:
SUSPENDED
Last Update Posted:
2015-07-17
First Post:
2011-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Xenogenic Keratoplasty From Porcine Cornea
Sponsor:
Xiamen University
Organization:
Study Overview
Official Title:
Phase I Study of Xenogenic Keratoplasty From Porcine Cornea in the Treatment of Infectious Corneal Ulcer
Status:
SUSPENDED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
there was not enough patients recruited in this study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
XKFPC
Brief Summary:
Acellular porcine cornea is a valid substitution for human cornea because of its similar biological structure, corneal superficial curvature and good histocompatibility toward human. Facing the lack of human cornea donor, it is hypothesised that using acellular lamellar porcine cornea as an alternative of lamellar human cornea to treat infectious corneal ulcer.
Detailed Description:
Acellular porcine cornea eligibility criteria:
1. fresh porcine cornea,
2. porcine cornea keeping transparent without scar, neovascularization or corneal ulcer,
3. porcine cornea keeping integrative corneal epithelium and endothelium,
4. acellular porcine cornea keeping transparent.
1. fresh porcine cornea,
2. porcine cornea keeping transparent without scar, neovascularization or corneal ulcer,
3. porcine cornea keeping integrative corneal epithelium and endothelium,
4. acellular porcine cornea keeping transparent.
Study Oversight
Has Oversight DMC:
True
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?: