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

Completed

• Conditions: Thermal Burn

• Registration Number: NCT02362386
• Lead Sponsor: Cytori Therapeutics

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.

Study Timeline

• Study First Submitted: 2015-02-09
• Study First Submitted QC: 2015-02-09
• Study First Posted: 2015-02-12
• Study Start: 2015-06
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-04
• Last Update Posted: 2016-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Logistical Feasibility of Preparing ADRCs from discarded eschar tissue	1 day	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

Secondary Outcome Measures

Name	Time	Method
Cell Characterization	1 day	Cell viability, cell yield, non-DNA-based cell phenotype, microbiology

Trial Locations

Locations (4)

Arizona Burn Center at Maricopy Integrated Health Systems; 🇺🇸 Phoenix, Arizona, United States

UC San Diego Medical Center; 🇺🇸 San Diego, California, United States

University of Texas Medical Branch and Shriners Hospital for Children; 🇺🇸 Galveston, Texas, United States

University ofWashington/Harborview Medical Center; 🇺🇸 Seattle, Washington, United States