Thermal Burn Clinical Trial
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)
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.
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.
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Observational Model: Case-Only, Time Perspective: Prospective
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