NCT05344521 - A Phase I, Single-blind, Randomized Study of the Safety and Efficacy of Cellularized Integra® Using Autologous Burn-derived Stem Cells | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

February 29, 2024

Primary Completion Date

February 28, 2026

Study Completion Date

February 28, 2027

Conditions

Burns

Interventions

DEVICE

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).

DEVICE

Integra®-SC

A combination of Integra® incorporated with 5,000-20,000 cells/cm2 of autologous burned derived stem cells.

Trial Locations (1)

L8L 2X2

Hamilton General Hospital, Hamilton