Ignite Creation Date:
2024-05-06 @ 10:44 AM
Last Modification Date:
2024-10-26 @ 12:34 PM
Study NCT ID:
NCT03339973
Status:
TERMINATED
Last Update Posted:
2020-06-29
First Post:
2017-10-11
Brief Title:
Allogeneic ABCB5-positive Stem Cells for Treatment of PAOD
Sponsor:
RHEACELL GmbH Co KG
Organization:
RHEACELL GmbH Co KG
Study Overview
Official Title:
A Randomised Placebo-controlled Double-blind Interventional Multicenter Phase IIIa Clinical Trial to Investigate the Efficacy and Safety of Allo-APZ2-PAOD for the Treatment of Peripheral Arterial Occlusive Disease PAOD
Status:
TERMINATED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Very slow recruitment of patients and the current COVID-19 pandemic situation
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 Peripheral Arterial Occlusive Disease-related clinically relevant ulcers and safety by monitoring adverse events of one dose of allo-APZ2-PAOD administered intramuscularly into an affected lower leg of patients with Peripheral Arterial Occlusive Disease
Detailed Description:
This is an interventional randomised placebo-controlled double-blind phase IIIa clinical trial to investigate the efficacy and safety of allo-APZ2-PAOD for the treatment of Peripheral Arterial Occlusive Disease patients with non-healing ulcers The allogeneic investigational product allo-APZ2-PAOD contains skin-derived ABCB5-positive mesenchymal stem cells isolated from skin tissue of healthy donors and stored in a donor cell bank
Patients are followed up for efficacy for 12 weeks by clinical visits at the clinical trial sites to monitor wound healing The wound healing process of all relevant ulcers will be documented by standardized photography and the quality of the wound healing process will be assessed
Pain will be assessed using a numerical rating scale and quality of life will be investigated with a standardized and validated questionnaire To assess long-term safety of allo-APZ2-PAOD three follow-up visits at Months 6 9 and 12 post IMP applications are included An unblinded external Independent Data Monitoring Committee IDMC will continuously monitor safety throughout the study
Patients are followed up for efficacy for 12 weeks by clinical visits at the clinical trial sites to monitor wound healing The wound healing process of all relevant ulcers will be documented by standardized photography and the quality of the wound healing process will be assessed
Pain will be assessed using a numerical rating scale and quality of life will be investigated with a standardized and validated questionnaire To assess long-term safety of allo-APZ2-PAOD three follow-up visits at Months 6 9 and 12 post IMP applications are included An unblinded external Independent Data Monitoring Committee IDMC will continuously monitor safety throughout the study
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