Prospective Evaluation of the ReCell® Autologous Cell Harvesting Device For Specific Compassionate Use Cases

Completed

Conditions studied: Burns

In brief

This is a prospective uncontrolled observational study to evaluate clinical outcomes following use of the ReCell Autologous Cell Harvesting Device (ReCell) as an adjunct for closure (re-epithelialization) as a treatment of life-threatening wounds requiring grafting for closure, and associated skin graft donor sites, in patients who lack adequate available skin to harvest for conventional grafting. Treatment with the ReCell device may be performed as part of a single operative procedure, or multiple staged procedures as deemed clinically necessary. Adverse events associated with the use of the ReCell device/cell suspension will be documented. Subjects will be followed for 1 year following ReCell treatment.

Key facts

Study ID

NCT02992249

Run by

Avita Medical

People needed

100

Starts

2014-05-01

Expected to finish

2020-06-01

Last updated by the study team

2020-08-03

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The patient requires treatment of a life-threatening wound requiring grafting.
• Patient has inadequate available skin to harvest for conventional skin grafting.
• The treating investigator has determined 1) that there is no suitable alternative therapy that would be adequate to meet the patient's medical need; and 2) the risk associated with use of the ReCell device is no greater than the probable risk from the disease or condition.
• In the treating investigator's opinion and with consideration of the severity of the patient's health status, the patient has the potential to realize benefits from the application of the ReCell device.
• Patient is hemodynamically stable.
• The patient (or legal representative) is able to read and understand instructions and give informed consent.

You may not qualify if…

• The patient has active infection at the proposed ReCell treatment site.
• The patient is unable to follow the protocol.
• The patient has a known hypersensitivity to trypsin or Compound Sodium Lactate for Irrigation (Hartmann's) solution.

Where it is running

• University of South Alabama Department of Surgery — Mobile, Alabama, United States
• Arizona Burn Center at Maricopa Integrated Health Systems — Phoenix, Arizona, United States
• University of California San Diego Regional Burn Center — San Diego, California, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Grady Memorial Hospital — Atlanta, Georgia, United States
• Joseph M Still Research Foundation — Augusta, Georgia, United States
• Richard M. Fairbanks Burn Center at Eskenazi Health — Indianapolis, Indiana, United States
• Baton Rouge General Regional Burn Center — Baton Rouge, Louisiana, United States
• University Medical Center — New Orleans, Louisiana, United States
• Maine Medical Center — Portland, Maine, United States
• Walter Reed National Military Medical Center Bethesda — Bethesda, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Shriner's Boston — Boston, Massachusetts, United States
• MS Burn & Reconstruction Center, Merit Health Central — Jackson, Mississippi, United States
• University of Missouri Health Care — Columbia, Missouri, United States
• Children's Mercy Kansas City — Kansas City, Missouri, United States
• Mercy General Burn Center - Springfield — Springfield, Missouri, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• St. Christopher's Hospital for Children — Philadelphia, Pennsylvania, United States
• University of Tennessee Health Science Center — Memphis, Tennessee, United States
• U.S.Army Institute of Surgical Research — Fort Sam Houston, Texas, United States
• University of Texas Health Science Center at Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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