Clinical Trial

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

Study acronym: Integra®-SC

Not Yet Recruiting Phase 1

Record status

This record was last updated December 15, 2023 (before its estimated February 2026 completion). Its status may not reflect the trial's current state.

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.

Protocol Amendment History 5 amendments

This ClinicalTrials.gov record has been amended 5 times since 2022-04-21; most recent amendment 2023-12-11.

Trial Details

NCT Number	NCT05344521
Lead Sponsor	Hamilton Health Sciences Corporation Collaborators: AFP Innovation Fund, Ontario Institute for Regenerative Medicine, Stem Cell Network
Conditions	Burns
Enrollment	29 participants
Start Date	2024-02
Primary Completion	2026-02 (estimated)
Study Completion	2027-02 (estimated)
Updated on ClinicalTrials.gov	2023-12-15