Ignite Creation Date:
2024-07-17 @ 11:13 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06489028
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-25
Brief Title:
Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Therapy-resistant CVU Phase III
Sponsor:
RHEACELL GmbH Co KG
Organization:
RHEACELL GmbH Co KG
Study Overview
Official Title:
A Pivotal Randomized Placebo-controlled Double-blind Multicenter International Phase III Clinical Trial to Investigate the Efficacy and Safety of Allo-APZ2-CVU on Wound Healing of Therapy-Resistant Non-Healing Chronic Venous Ulcers CVU
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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 and safety of allo-APZ2-CVU administered topically on therapy-resistant non-healing CVUs compared to placebo
Detailed Description:
This is a pivotal randomized placebo-controlled double-blind multicenter international phase III clinical trial to investigate the efficacy and safety of the IMP allo-APZ2-CVU on wound healing in patients with therapy-resistant non-healing CVU
The allogeneic IMP allo-APZ2-CVU contains skin-derived ABCB5-positive dermal mesenchymal stromal cells isolated from skin tissue of healthy donors and stored in a donor cell bank
Patients will be randomized to be treated with allo-APZ2-CVU or placebo The patients will undergo treatment with the IMP on Day 0 V3 and will be followed up for efficacy for 18 weeks V4 until V14 Three safety follow-up visits will be performed at Month 6 V15 Month 10 V16 and Month 16 V17
The wound healing process will be documented by standardized photography
The wound size measurement will start at the first Screening Visit V1 and will be measured at each following on-site visit
Pain will be assessed using a numerical rating scale and quality of life will be investigated with standardized and validated questionnaires
The allogeneic IMP allo-APZ2-CVU contains skin-derived ABCB5-positive dermal mesenchymal stromal cells isolated from skin tissue of healthy donors and stored in a donor cell bank
Patients will be randomized to be treated with allo-APZ2-CVU or placebo The patients will undergo treatment with the IMP on Day 0 V3 and will be followed up for efficacy for 18 weeks V4 until V14 Three safety follow-up visits will be performed at Month 6 V15 Month 10 V16 and Month 16 V17
The wound healing process will be documented by standardized photography
The wound size measurement will start at the first Screening Visit V1 and will be measured at each following on-site visit
Pain will be assessed using a numerical rating scale and quality of life will be investigated with standardized and validated questionnaires
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