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

Hamilton Health Sciences (HHS)

Status and phase: Not yet enrolling; Phase 1

Conditions: Burns

Treatments: Device: Integra®; Device: Integra®-SC

Study type: Interventional

Funder types: Other

Identifiers

NCT05344521

15229

Details and patient eligibility

About

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.

Enrollment: 29 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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29 participants in 2 patient groups

Control

Active Comparator group

Description:

After removal of the temporary wound coverage (allograft), Integra® is applied directly onto the wound surface.

Treatment:

Device: Integra®

Integra®-SC

Experimental group

Description:

After removal of the temporary wound coverage (allograft), Integra®-SC is applied to the contralateral area of the site where Integra® is applied.

Treatment:

Device: Integra®-SC