Status:
NOT_YET_RECRUITING
A Phase I, Single-blind, Randomized Study of the Safety and Efficacy of Cellularized Integra® Using Autologous Burn-derived Stem Cells
Lead Sponsor:
Hamilton Health Sciences Corporation
Collaborating Sponsors:
AFP Innovation Fund
Ontario Institute for Regenerative Medicine
Conditions:
Burns
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 tissu...
Eligibility Criteria
Inclusion
- Aged ≥ 18 years.
- Total body surface area (TBSA) ≥ 5%.
- Full-thickness burn requiring operative procedures.
- Admitted ≤ 120 hours following burn.
- Injury location includes a contralateral area.
Exclusion
- All participants meeting any of the following exclusion criteria at baseline will be excluded from participation in this study:
- Patients who are moribund.
- Known infection with any of the following: Human Immunodeficiency Virus (HIV), Hepatitis B, Hepatitis C, Human T-lymphotropic Virus (HTLV), Syphilis, or West Nile Virus.
- Injury location limited to face and/or hands.
- Pregnancy.
- Active cancer and currently undergoing treatment.
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT05344521
Start Date
February 1 2024
End Date
February 1 2027
Last Update
December 15 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2