Clinical trial NCT02362386: Feasibility of Obtaining ADRCs From Discarded Thermal Burn Eschar Tissue Using Investigational Celution® System
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thermal Burn
Lead sponsor: Cytori Therapeutics
Sponsor class: INDUSTRY
First posted: 2015-02-12
Enrollment: 17
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Target population includes patients with a burn injury that requires surgery in which fat excision of approximately 100 g (or more) is anticipated

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.

Eligibility criteria: Inclusion Criteria

1. Males or females ≤ 80 years of age
2. Admission to hospital for acute burn injury
3. Planned escharectomy anticipated to yield at least 100 g adipose tissue according to the treating surgeon's clinical judgment.

Exclusion Criteria

1. Known history of HIV infection, or has active Hepatitis B or active Hepatitis C infection
2. Pre-existing condition requiring current use of immunosuppressive medication or systemic steroids
3. Cancer requiring chemotherapy or radiation within previous 12 months

Primary outcomes:
measure: Logistical Feasibility of Preparing ADRCs from discarded eschar tissue
timeFrame: 1 day
Secondary outcomes:
measure: Cell Characterization
timeFrame: 1 day
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Burn Center at Maricopy Integrated Health Systems
state: Arizona
city: San Diego
country: United States
facility: UC San Diego Medical Center
state: California
city: Galveston
country: United States
facility: University of Texas Medical Branch and Shriners Hospital for Children
state: Texas
city: Seattle
country: United States
facility: University ofWashington/Harborview Medical Center
state: Washington
Study officials:
affiliation: Cytori Therapeutics, Inc.
name: Steven Kesten, MD
role: STUDY_DIRECTOR
References: