Feasibility of Obtaining ADRCs From Discarded Thermal Burn Eschar Tissue Using Investigational Celution® System

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to assess the logistical and biological feasibility of preparing ADRCs from adipose tissue excised during standard-of-care burn wound excision using the Celution® System for autologous, same-day application to the burn wound.

Detailed Description
-----------------
This study is a non-interventional clinical study. Adipose tissue excised as part of usual care of burn wound that would otherwise be discarded will be collected for processing and analysis. Target population includes patients with a burn injury that requires surgery in which fat excision of approximately 100 g (or more) is anticipated. The scope of the study includes: Fat tissue collected from tangential or fascial excision will be manually prepared for processing within the investigational Celution® System Adipose tissue will be processed using the investigational Celution® System. ADRC yield and viability will be evaluated using a NucleoCounter® device Age, gender, weight, height, location/severity/%TBSA of burn, time/date of burn injury, current stage of health will be collected Operational details such as start and stop time of tissue excision, adipose tissue preparation and Celution® processing, cell counting and dose preparation will be collected. In addition, weight of excised tissue prior to and after preparation, weight of adipose tissue processed by Celution Device and ADRC yield and viability will be recorded. Several samples will be collected and sent to a central microbiology laboratory for microbiological testing.

Official Title
-----------------
Feasibility of Obtaining Adipose Derived Regenerative Cells (ADRCs) From Discarded Thermal Burn Eschar Tissue Using Investigational Celution® System for Autologous Treatment of Thermal Burn Injury (The FAST Trial)

Conditions
-----------------
Thermal Burn

Intervention / Treatment
-----------------
* Device: Celution Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Males or females ≤ 80 years of age Admission to hospital for acute burn injury Planned escharectomy anticipated to yield at least 100 g adipose tissue according to the treating surgeon's clinical judgment. Exclusion Criteria Known history of HIV infection, or has active Hepatitis B or active Hepatitis C infection Pre-existing condition requiring current use of immunosuppressive medication or systemic steroids Cancer requiring chemotherapy or radiation within previous 12 months

Ages Eligible for Study
-----------------
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Celution Device|Non-interventional evaluation of Celution Device preparation of ADRCs from thermal burn eschar tissue that would normally be discarded.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Logistical Feasibility of Preparing ADRCs from discarded eschar tissue | Examine various parameters including time to assess how processing of adipose tissue using Celution Device could be integrated into standard-of-care thermal burn wound excision | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cell Characterization | Cell viability, cell yield, non-DNA-based cell phenotype, microbiology | 1 day |