Ignite Creation Date:
2024-05-06 @ 4:24 PM
Last Modification Date:
2024-10-26 @ 2:09 PM
Study NCT ID:
NCT04971161
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2021-06-07
Brief Title:
Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of CVU Phase IIb
Sponsor:
RHEACELL GmbH Co KG
Organization:
RHEACELL GmbH Co KG
Study Overview
Official Title:
A Randomized Placebo-Controlled Double-blind Dose-Ranging Multicenter Phase IIb Clinical Trial to Investigate the Efficacy and Safety of Allo-APZ2-CVU on Wound Healing of Therapy-Resistant Chronic Venous Ulcer CVU
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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 CVUs and safety by monitoring adverse events AEs of three dose groups of the investigational medicinal product IMP allo-APZ2-CVU topically administered on target wounds of patients with CVU compared to placebo
Detailed Description:
This is a randomized placebo-controlled double-blind dose-ranging multicenter phase IIb clinical trial to investigate the efficacy and safety of the IMP allo-APZ2-CVU on wound healing in patients with therapy-resistant 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 dose 1 dose 2 dose 3 or placebo 50 patients per dose group 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 Two safety follow-up visits will be performed at Month 6 V15 and Month 10 V16 An additional visit V17 will be performed to follow up on target wounds of all patients who reached the primary endpoint ie wound was closed at V13 and V14 at Month 16 at least
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
Patients will be randomized to be treated with allo-APZ2-CVU dose 1 dose 2 dose 3 or placebo 50 patients per dose group 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 Two safety follow-up visits will be performed at Month 6 V15 and Month 10 V16 An additional visit V17 will be performed to follow up on target wounds of all patients who reached the primary endpoint ie wound was closed at V13 and V14 at Month 16 at least
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?:
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-510162-27-00 | CTIS | None | None |
| U1111-1301-6596 | REGISTRY | None | None |
| 2020-004960-24 | EUDRACT_NUMBER | None | None |