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)
1 other identifier
observational
17
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2015
Shorter than P25 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2015
CompletedFirst Posted
Study publicly available on registry
February 12, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedApril 5, 2016
April 1, 2016
8 months
February 9, 2015
April 4, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Cell Characterization
1 day
Interventions
Non-interventional evaluation of Celution Device preparation of ADRCs from thermal burn eschar tissue that would normally be discarded.
Eligibility Criteria
Target population includes patients with a burn injury that requires surgery in which fat excision of approximately 100 g (or more) is anticipated
You may qualify if:
- Males or females ≤ 80 years of age
- Admission to hospital for acute burn injury
- Planned escharectomy anticipated to yield at least 100 g adipose tissue according to the treating surgeon's clinical judgment.
You may not qualify if:
- Known history of HIV infection, or has active Hepatitis B or active Hepatitis C infection
- Pre-existing condition requiring current use of immunosuppressive medication or systemic steroids
- Cancer requiring chemotherapy or radiation within previous 12 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Arizona Burn Center at Maricopy Integrated Health Systems
Phoenix, Arizona, 85008, United States
UC San Diego Medical Center
San Diego, California, 92103, United States
University of Texas Medical Branch and Shriners Hospital for Children
Galveston, Texas, 77555, United States
University ofWashington/Harborview Medical Center
Seattle, Washington, 98104, United States
Biospecimen
Adipose tissue and adipose derived regenerative cells (ADRCs) will be obtained for microbiological testing and for non-DNA-based cell characterization.
Study Officials
- STUDY DIRECTOR
Steven Kesten, MD
Cytori Therapeutics, Inc.
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2015
First Posted
February 12, 2015
Study Start
June 1, 2015
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
April 5, 2016
Record last verified: 2016-04