Cellularized Integra® for Burns
(Integra®-SC Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Integra®-SC for burns?
Integra, an artificial skin, has been shown to decrease the length of hospital stay for severely injured burn patients, especially those with multiple risk factors. It also provides protection against fluid loss and bacterial invasion, leading to functionally and aesthetically acceptable scar formation.12345
Is Cellularized Integra® safe for use in humans?
Integra, an artificial skin substitute, has been used in treating burns and has shown to be generally safe, though infections are a common complication. In a study, 42% of patients experienced infections, often involving bacteria like Pseudomonas aeruginosa and Staphylococcus aureus, suggesting that careful application and monitoring are important to reduce infection risks.24567
How does the treatment Integra®-SC differ from other treatments for burns?
Integra®-SC is unique because it is an artificial skin substitute that provides immediate full-thickness reconstruction for burns, using a collagen/glycosaminoglycane matrix and a silicon layer to protect tissue and promote the formation of a new dermis. This approach is particularly beneficial for massive burns where donor skin is limited, offering superior functional and cosmetic outcomes compared to traditional methods.23458
What is the purpose of this trial?
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.
Research Team
Marc G Jeschke, MD PhD
Principal Investigator
Hamilton Health Sciences Corporation
Eligibility Criteria
Adults with burns covering at least 5% of their body, needing surgery, and admitted within 120 hours after the burn can join. The trial is not for those with active cancer treatments, severe health conditions, certain infections (HIV, Hepatitis B/C, HTLV, Syphilis or West Nile Virus), burns only on face/hands or if pregnant.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Integra® or Integra®-SC applied to the wound surface after removal of temporary wound coverage
Follow-up
Participants are monitored for safety and effectiveness after treatment, including scar formation and wound healing
Treatment Details
Interventions
- Integra®-SC
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hamilton Health Sciences Corporation
Lead Sponsor
Sunnybrook Health Sciences Centre
Lead Sponsor
Stem Cell Network
Collaborator
Ontario Institute for Regenerative Medicine
Collaborator
AFP Innovation Fund
Collaborator