Ignite Creation Date:
2024-05-06 @ 10:24 AM
Last Modification Date:
2024-10-26 @ 12:30 PM
Study NCT ID:
NCT03257098
Status:
COMPLETED
Last Update Posted:
2020-09-10
First Post:
2017-08-17
Brief Title:
Allogeneic ABCB5-positive Stem Cells for Treatment of CVU
Sponsor:
RHEACELL GmbH Co KG
Organization:
RHEACELL GmbH Co KG
Study Overview
Official Title:
An Interventional Single Arm Multicenter Phase IIIa Clinical Trial to Investigate the Efficacy and Safety of Allo-APZ2-CVU on Wound Healing of Chronic Venous Ulcer CVU
Status:
COMPLETED
Status Verified Date:
2020-09
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:
None
Brief Summary:
The aim of this clinical trial is to investigate the efficacy by monitoring the wound size reduction of Chronic Venous Ulcers and safety by monitoring adverse events of the medicinal product to be studied after two applications on the wound surface in patients with Chronic Venous Ulcers
Detailed Description:
This is an interventional single arm phase IIIa clinical trial to investigate the efficacy and safety of allogeneic ABCB5-positive mesenchymal stem cells MSCs on wound healing in patients with chronic venous ulcer CVU Allogeneic MSCs will be isolated ex vivo and will be expanded in vitro The IMP incorporating the ABCB5-positive MSCs will then be applied on the wound surface of CVU under local anesthesia on Day 0 and Week 61
Wound measurements from Visit V 2 and V9 will be used to determine the cell amount for the IMP treatments on V3 and V10 respectively
Patients are followed up for efficacy for 3 months which allows to distinguish actual wound healing from transient wound coverage
The wound healing process will be documented by standardized photography The wound size evaluation will start on the day of the first change of wound dressing The quality of the wound healing process will be assessed on the basis of formation of granulation tissue epithelialization and wound exudation
Pain will be assessed using a numerical rating scale and quality of life will be investigated with standardized and validated questionnaires To assess long-term safety of allo-APZ2-CVU three follow-up visits at Months 6 9 and 12 after the first IMP applications are included
Wound measurements from Visit V 2 and V9 will be used to determine the cell amount for the IMP treatments on V3 and V10 respectively
Patients are followed up for efficacy for 3 months which allows to distinguish actual wound healing from transient wound coverage
The wound healing process will be documented by standardized photography The wound size evaluation will start on the day of the first change of wound dressing The quality of the wound healing process will be assessed on the basis of formation of granulation tissue epithelialization and wound exudation
Pain will be assessed using a numerical rating scale and quality of life will be investigated with standardized and validated questionnaires To assess long-term safety of allo-APZ2-CVU three follow-up visits at Months 6 9 and 12 after the first IMP applications are included
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