Ignite Creation Date:
2024-05-06 @ 10:27 AM
Last Modification Date:
2024-10-26 @ 12:30 PM
Study NCT ID:
NCT03267784
Status:
COMPLETED
Last Update Posted:
2020-09-10
First Post:
2017-08-17
Brief Title:
Allogeneic ABCB5-positive Stem Cells for Treatment of DFU Malum Perforans
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-DFU on Wound Healing of Diabetic Neuropathic Ulcer DFU
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 surface area reduction of Diabetic Foot Ulcers and safety by monitoring adverse events of two doses of the allogeneic investigational medicinal product allo-APZ2-DFU topically administered to the wound matrix of patients with diabetic neuropathic ulcer
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 diabetic neuropathic ulcer Allogeneic MSCs will be isolated ex vivo and will be expanded in vitro The Investigational medicinal product IMP containing the ABCB5-positive MSCs will then be applied two times at Visit 3 and six weeks later at Visit 10 on the wound surface of DFU
Patients are followed up for efficacy for a period of three months starting after the first IMP application which allows to distinguish actual wound healing from transient wound coverage
The wound healing process will be documented by standardized photography The wound size reduction evaluation will start two weeks after the first IMP application 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-DFU three follow-up visits at Months 6 9 and 12 after the first IMP application are included
Patients are followed up for efficacy for a period of three months starting after the first IMP application which allows to distinguish actual wound healing from transient wound coverage
The wound healing process will be documented by standardized photography The wound size reduction evaluation will start two weeks after the first IMP application 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-DFU three follow-up visits at Months 6 9 and 12 after the first IMP application 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