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

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02362386
• Other study ID #: The FAST Study
• Status: Completed
• Phase: N/A
• First received: February 9, 2015
• Last updated: April 4, 2016
• Start date: June 2015
• Est. completion date: February 2016

Study information

• Verified date: April 2016
• Source: Cytori Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 80 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Burns
• Thermal Burn

Intervention

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

Locations

Country	Name	City	State
United States	University of Texas Medical Branch and Shriners Hospital for Children	Galveston	Texas
United States	Arizona Burn Center at Maricopy Integrated Health Systems	Phoenix	Arizona
United States	UC San Diego Medical Center	San Diego	California
United States	University ofWashington/Harborview Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Cytori Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Cell Characterization	Cell viability, cell yield, non-DNA-based cell phenotype, microbiology	1 day	Yes