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A Phase I, Single-blind, Randomized Study of the Safety and Efficacy of Cellularized Integra® Using Autologous Burn-derived Stem Cells — Integra®-SC  

Burns Clinical Trial

Official title:
A Phase I, Single-blind, Randomized Study of the Safety and Efficacy of Cellularized Integra® Using Autologous Burn-derived Stem Cells

Clinical Trial Summary

Burn injuries are one of the most severe skin injuries and lead to a complex wound healing response. When the skin is wounded, stem cells in the skin must respond fast to help repair the injured tissue. The damaged skin of burn patients contains cells that are still alive and have typical stem cell characteristics. Because stem cells are so important for wound healing, the investigators have combined them with an existing skin substitute, Integra®, to examine the potential wound healing benefits of these stem cells. This is an investigational treatment and a first in-human trial. The purpose of this study is to test the safety of using a patient's own stem cells combined with Integra®, which the investigators call Integra®-Stem Cells (Integra®-SC). The investigators hypothesize that Integra®-SC will result in improved wound healing, better scar quality, and decreased scar formation at one-year post-injury.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05344521
Study type Interventional
Source Hamilton Health Sciences Corporation
Contact Marc G Jeschke, MD PhD
Phone 905-521-2100
Email marc.jeschke@hhsc.ca
Status Not yet recruiting
Phase Phase 1
Start date February 2024
Completion date February 2027
View Details
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