Ignite Creation Date:
2024-05-06 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 12:46 PM
Study NCT ID:
NCT03529877
Status:
COMPLETED
Last Update Posted:
2022-10-07
First Post:
2018-04-24
Brief Title:
Allogeneic ABCB5-positive Stem Cells for Treatment of Epidermolysis Bullosa
Sponsor:
RHEACELL GmbH Co KG
Organization:
RHEACELL GmbH Co KG
Study Overview
Official Title:
An Interventional Multicenter Single Arm Phase IIIa Clinical Trial to Investigate the Efficacy and Safety of Allo-APZ2-EB on Epidermolysis Bullosa EB
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this clinical trial is to investigate the efficacy by monitoring overall improvement of EB symptoms and safety by monitoring adverse events of three doses of allo-APZ2-EB administered intravenously to patients with recessive dystrophic epidermolysis bullosa RDEB
Detailed Description:
This is an interventional single arm non-randomized open label phase IIIa clinical trial to investigate the efficacy and safety of the IMP allo-APZ2-EB in patients with RDEB
Patients will undergo treatment with the IMP three repeated intravenous applications and will be followed up for efficacy for 12 weeks To assess long-term safety of allo-APZ2-EB one follow-up visit at Month 12 and one follow-up visit at Month 24 post IMP applications is included
Determination of the EB linked symptoms and quality of life will be assessed by using the EBDASI score the iscorEB the change in pain and itch perception and patients quality of life in EB The wound healing process will be documented by photography
Patients will undergo treatment with the IMP three repeated intravenous applications and will be followed up for efficacy for 12 weeks To assess long-term safety of allo-APZ2-EB one follow-up visit at Month 12 and one follow-up visit at Month 24 post IMP applications is included
Determination of the EB linked symptoms and quality of life will be assessed by using the EBDASI score the iscorEB the change in pain and itch perception and patients quality of life in EB The wound healing process will be documented by photography
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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