Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Phase I, Single-blind, Randomized Study of the Safety and Efficacy of Cellularized Integra® Using Autologous Burn-derived Stem Cells
Sponsor: Hamilton Health Sciences Corporation
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
29
Start Date
2024-02
Completion Date
2027-02
Last Updated
2023-12-15
Healthy Volunteers
No
Conditions
Interventions
Integra®
A commercially available dermal bovine matrix that is widely used for wound and burn care, Integra® Dermal Regeneration Template licensed device (Medical Device Active License Listing No. 229).
Integra®-SC
A combination of Integra® incorporated with 5,000-20,000 cells/cm2 of autologous burned derived stem cells.
Locations (1)
Hamilton General Hospital
Hamilton, Ontario, Canada