Feasibility of Obtaining ADRCs From Discarded Thermal Bur... | NCT02362386

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

NCT02362386

Sponsor

Cytori Therapeutics

Status

Completed

Last Update Posted

Apr 5, 2016Estimated

Enrollment

17Actual

Phase

Not provided

Conditions

Thermal Burn

Interventions

Celution Device

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015

Primary Completion Date

Feb 2016Actual

Completion Date

Feb 2016Actual

First Submitted Date

Feb 9, 2015

First Submission Date that Met QC Criteria

Feb 9, 2015

First Posted Date

Feb 12, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2016

Last Update Posted Date

Apr 5, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

17Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Celution Device	Device	Non-interventional evaluation of Celution Device preparation of ADRCs from thermal burn eschar tissue that would normally be discarded.

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

80 Years

Standard Ages

ChildAdultOlder 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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Steven Kesten, MD	Cytori Therapeutics, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Arizona Burn Center at Maricopy Integrated Health Systems		Phoenix	Arizona	85008	United States
UC San Diego Medical Center