Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-03-03 @ 3:00 PM
Study NCT ID:
NCT02284360
Status:
COMPLETED
Last Update Posted:
2015-09-28
First Post:
2014-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Randomized Double-Blinded Placebo Controlled, Explorative Phase I Trial to Investigate the Safety and Tolerability of Two Different Doses of Topically Administered APOSEC™ in Healthy Male Subjects With Artificial Dermal Wounds
Sponsor:
Medical University of Vienna
Organization:
Study Overview
Official Title:
A Prospective Randomized Double-Blinded Placebo Controlled, Explorative Phase I Trial to Investigate the Safety and Tolerability of Two Different Doses of Topically Administered APOSEC™ in Healthy Male Subjects With Artificial Dermal Wounds
Status:
COMPLETED
Status Verified Date:
2015-09
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:
This is a prospective, single center, randomized, double-blinded, placebo-controlled, exploratory phase I clinical trial in healthy male subjects to investigate the safety and tolerability of the cytokine based gel APOSEC™. The proof of safety and tolerability of APOSEC™ is the primary objective. The secondary objective is to measure the extent of wound healing of APOSEC™.
Detailed Description:
APOSEC™ is a human product derived from lyophilized conditional medium of peripheral blood mononuclear cells (PBMC) following 24 hours cultivation after irradiation with 60Gy. The soluble factors produced by these factors (secretome) have regenerative functions and enhance wound healing due to the activation of signaling cascades involved in the cell migration, proliferation and cell survival. The product also possesses strong angiogenic properties as well in vivo and in vitro. APOSEC™ is intended for topical use only, to promote healing of wounds in association with standard wound care. Standard wound care includes initial debridement, avoidance and treatment of wound related infections and a non-weight-bearing regime to decrease the pressure on the wound.
The verum APOSEC™ is processed as lyophilisate and resuspended in Nugel for the final formulation. It will be compared with a placebo, a cell-free parallel produced cell-free control lyophilisate that is finally formulated in Nugel as well.
10 eligible healthy volunteers will consecutively be allocated to 2 different dose groups of APOSEC™ in a dose escalation scheme. The first 5 subjects in group A receive the low dose of APOSEC™ (12.5\*10\^6 lyophilized PBMC/mL), the subsequent 5 subjects in group B will receive the high dose of APOSEC™ (25\*10\^6 lyophilized PBMC/mL). Each volunteer will receive both Verum and Placebo on two artificial wounds on the inner upper non-dominant arm. The location of application of the Verum and Placebo (proximal or distal) is subjected to randomization.
The verum APOSEC™ is processed as lyophilisate and resuspended in Nugel for the final formulation. It will be compared with a placebo, a cell-free parallel produced cell-free control lyophilisate that is finally formulated in Nugel as well.
10 eligible healthy volunteers will consecutively be allocated to 2 different dose groups of APOSEC™ in a dose escalation scheme. The first 5 subjects in group A receive the low dose of APOSEC™ (12.5\*10\^6 lyophilized PBMC/mL), the subsequent 5 subjects in group B will receive the high dose of APOSEC™ (25\*10\^6 lyophilized PBMC/mL). Each volunteer will receive both Verum and Placebo on two artificial wounds on the inner upper non-dominant arm. The location of application of the Verum and Placebo (proximal or distal) is subjected to randomization.
Study Oversight
Has Oversight DMC:
False
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?: