Safety and Feasibility of ADRCs Treatment To Patients With Thermal Wounds

Summary

Participation Requirements

Description

The RELIEF Trial is a prospective, open-label, parallel group, usual care controlled, multi-center randomized (2:1, active: usual care alone) safety and feasibility study targeting thermal burns. Subjects will have at least one deep partial or full thickness burn wounds of > 250 cm2 that is to be au...

The RELIEF Trial is a prospective, open-label, parallel group, usual care controlled, multi-center randomized (2:1, active: usual care alone) safety and feasibility study targeting thermal burns. Subjects will have at least one deep partial or full thickness burn wounds of > 250 cm2 that is to be autografted with a split thickness meshed skin graft (STSG). Subjects randomized to ADRCs will undergo small volume fat harvest (100 to 150 mL) performed at initiation of general anesthesia for scheduled burn surgery followed by intravenous delivery of ADRCs within 4 hours following surgery. The lipoaspirate will be processed in the Celution® System to isolate and concentrate ADRCs. Following informed consent and initial screening assessments, eligible subjects will undergo pre-operative testing. On the procedure day, subjects will be randomized to ADRCs (with usual care) or usual care alone. Low volume lipoharvest will only be performed on subjects randomized to ADRCs in order to obtain 100-150 mL lipoaspirate, which will then be transferred to the Celution® System for processing to isolate and concentrate ADRCs for same-day administration. All treatment will be delivered in a total volume of 10 mL which will be delivered by slow intravenous administration into a peripheral vein. Following surgery, subjects will be evaluated at first dressing change, day 10 (±2) (only if wound dressing change planned) and weeks 2 (±3 days), 3 (±3 days), 4 (±3 days), 8 (±7 days), 12 (±14 days), 26 (±14 days), and 52(±21 days). The 1st 5 subjects enrolled in active treatment will be observed for adverse events over a 7 day period. If no SAEs occur during that period, for that individual subject, the next subject enrolled in active treatment may be entered with the same 7 day observation period. The safety results of the first 5 subjects will be reviewed by the DMC and their evaluation will be used in conjunction with the clinical data collected to date, and if appropriate, to potentially remove the staggering approach to the study. Enrollment after the first 5 subjects may continue only after the DMC has completed its safety review and recommends continuation.

Tracking Information