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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

Study acronym: Integra®-SC
StatusNot Yet Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
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.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Jun 2025 to Feb 2026
    • Start date: Jun 2023 to Feb 2024
    • Study completion date: Jun 2026 to Feb 2027
    • Collaborators: 2 to 3
    v6
  2. 3 versions Re-verified since Jan 19, 2023, no change to tracked fieldsv3-v5
  3. Lead sponsor: Sunnybrook Health Sciences Centre to Hamilton Health Sciences Corporationv2 Show 6 more changesShow less
    • Primary completion date: Apr 2024 to Jun 2025
    • Start date: May 2022 to Jun 2023
    • Enrollment target: 24 to 29
    • Study completion date: Apr 2025 to Jun 2026
    • Study site revised
    • Study title expanded, about 7 words
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05344521
Lead Sponsor Hamilton Health Sciences Corporation
Collaborators: AFP Innovation Fund, Ontario Institute for Regenerative Medicine, Stem Cell Network
Conditions
(from sponsor)		 Burns
Related terms Burns, Cicatrix
Enrollment 29 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov