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

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.

Study Overview

• Status: Completed
• Conditions: Burns

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36688
      • University of South Alabama Department of Surgery
  • Arizona
    • Phoenix, Arizona, United States, 85008
      • Arizona Burn Center at Maricopa Integrated Health Systems
  • California
    • San Diego, California, United States, 92103-8896
      • University of California San Diego Regional Burn Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar Washington Hospital Center
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Grady Memorial Hospital
    • Augusta, Georgia, United States, 30909
      • JOSEPH M STILL RESEARCH FOUNDATION
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Richard M. Fairbanks Burn Center at Eskenazi Health
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Baton Rouge General Regional Burn Center
    • New Orleans, Louisiana, United States, 70112
      • University Medical Center
  • Maine
    • Portland, Maine, United States, 04102
      • Maine Medical Center
  • Maryland
    • Bethesda, Maryland, United States, 20889
      • Walter Reed National Military Medical Center Bethesda
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02114
      • Shriner's Boston
  • Mississippi
    • Jackson, Mississippi, United States, 39204
      • MS Burn & Reconstruction Center, Merit Health Central
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri Health Care
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Kansas City
    • Springfield, Missouri, United States, 65804
      • Mercy General Burn Center - Springfield
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19134
      • St. Christopher's Hospital for Children
  • Tennessee
    • Memphis, Tennessee, United States, 38103-3409
      • University of Tennessee Health Science Center
  • Texas
    • Fort Sam Houston, Texas, United States, 78234-7767
      • U.S.Army Institute of Surgical Research
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Healing	> 95% epithelialization with a contiguous layer of viable epithelium	Wound healing assessed at all study visits

Collaborators and Investigators

• Sponsor: Avita Medical

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: December 12, 2016
• First Submitted That Met QC Criteria: December 12, 2016
• First Posted (Estimate): December 14, 2016

Study Record Updates

• Last Update Posted (Actual): August 3, 2020
• Last Update Submitted That Met QC Criteria: July 31, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CTP004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No