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)

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.

Study Overview

• Status: Completed
• Conditions: Thermal Burn
• Intervention / Treatment: Device: Celution Device

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 Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85008
      • Arizona Burn Center at Maricopy Integrated Health Systems
  • California
    • San Diego, California, United States, 92103
      • UC San Diego Medical Center
  • Texas
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch and Shriners Hospital for Children
  • Washington
    • Seattle, Washington, United States, 98104
      • University ofWashington/Harborview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cell Characterization	Cell viability, cell yield, non-DNA-based cell phenotype, microbiology	1 day

Collaborators and Investigators

• Sponsor: Cytori Therapeutics
• Investigators: Study Director: Steven Kesten, MD, Cytori Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: February 9, 2015
• First Submitted That Met QC Criteria: February 9, 2015
• First Posted (Estimate): February 12, 2015

Study Record Updates

• Last Update Posted (Estimate): April 5, 2016
• Last Update Submitted That Met QC Criteria: April 4, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: The FAST Study