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

Cytori Therapeutics

Status: Completed

Conditions: Thermal Burn

Treatments: Device: Celution Device

Study type: Observational

Funder types: Industry

Identifiers

NCT02362386

The FAST Study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: Under 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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