NCT02362386

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

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 17 (actual)
• Sponsor: Cytori Therapeutics · Industry
• Sex: All
• Age: 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Thermal Burn

Interventions

Type	Name	Description
DEVICE	Celution Device	Non-interventional evaluation of Celution Device preparation of ADRCs from thermal burn eschar tissue that would normally be discarded.

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2015-02-12
• Last updated: 2016-04-05

Locations

4 sites across 1 country: United States