Ignite Creation Date:
2024-05-06 @ 8:28 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02742844
Status:
TERMINATED
Last Update Posted:
2020-07-07
First Post:
2016-04-07
Brief Title:
Clinical Trial to Investigate Efficacy and Safety of the IMP in Patients With Non Healing Wounds Originating From Ulcers
Sponsor:
RHEACELL GmbH Co KG
Organization:
RHEACELL GmbH Co KG
Study Overview
Official Title:
An Interventional Single Arm Phase IIIa Clinical Trial to Investigate the Efficacy and Safety of APZ2 on Wound Healing of Chronic Venous Ulcer CVU
Status:
TERMINATED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
COVID-19 pandemic and patient recruitment issues
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 and safety by monitoring occurring adverse events of the investigational medicinal product APZ2 after one single application on chronic venous leg ulcer wounds
Detailed Description:
This is an interventional single arm phase IIIa clinical trial to investigate the efficacy and safety of ABCB5 mesenchymal stem cells MSCs on wound healing in patients with chronic venous ulcer CVU Autologous MSCs will be isolated ex vivo from a small skin biopsy and will be expanded in vitro The IMP APZ2 containing the ABCB5 cells will then be applied on the wound surface of CVU under local anesthesia
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 APZ2 an additional follow-up visit at Month 12 post IMP application is included
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 APZ2 an additional follow-up visit at Month 12 post IMP application is included
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