Thermal BurnNCT02362386
Feasibility of Obtaining ADRCs From Discarded Thermal Burn Eschar Tissue Using Investigational Celution® System
An observational study of Thermal Burn, run by Cytori Therapeutics at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Thermal Burn
- What is being tested?
- Celution Device
- Type of treatment
- Medical device
- How many people
- 17 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2015to Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Texas Medical Branch and Shriners Hospital for Children
Galveston, Texas, 77555
Arizona Burn Center at Maricopy Integrated Health Systems
Phoenix, Arizona, 85008
UC San Diego Medical Center
San Diego, California, 92103
University ofWashington/Harborview Medical Center
Seattle, Washington, 98104
About this study
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)
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.
Read the 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.
- Conditions
- Thermal Burn
- Being tested
- Celution Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Celution DeviceDevice
Non-interventional evaluation of Celution Device preparation of ADRCs from thermal burn eschar tissue that would normally be discarded.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (1)
Cell Characterization
Cell viability, cell yield, non-DNA-based cell phenotype, microbiology
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2015 (estimated)
- Study startJun 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thermal BurnStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cytori Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Kesten, MD, Study director, Cytori Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02362386
- Sponsor's protocol ID
- The FAST Study
- Status last verified
- Apr 2016
- First submitted
- 9 Feb 2015
- Last updated
- 5 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02362386
- Acronym / sponsor ID
- The FAST Study
- Conditions
- Thermal Burn
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Cytori TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 12 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Celution DeviceNon-interventional evaluation of Celution Device preparation of ADRCs from thermal burn eschar tissue that would normally be discarded. | Device | – |
Primary outcome
Logistical Feasibility of Preparing ADRCs from discarded eschar tissue
Time frame: 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
1 secondary outcome
Cell Characterization
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Kesten, MD study director
Cytori Therapeutics, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thermal Burn, run by Cytori Therapeutics at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Logistical Feasibility of Preparing ADRCs from discarded eschar tissue (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2016.