The RELIEF clinical trial will test the safety of using ADRCs to help heal burn wounds and whether this would be a practical way to treat burns. This knowledge may help future burn patients, including members of our Armed Forces burned by improvised explosive devices or other enemy weapons.

Relief at a Glance

  • RELIEF is approved by the FDA to enroll up to 15 patients at up to 10 US clinical trial sites
  • RELIEF is funded by BARDA, a part of the US Department of Health and Human Services (for more information on BARDA see our “Other Resources” page)

  • Patients who meet study requirements and who agree to participate in the study will be enrolled into one of two arms
    • ADRC-treatment plus Standard Care
      • During their standard burn surgery patients will also undergo a small liposuction in which the surgeon will collect about half a cup of their fat tissue for preparation of ADRCs which will be delivered by intravenous injection.
      • There will be no other changes to the care and treatment that the patient would otherwise have at the burn center if they were not participating in the study
    • Control: Standard Care only
      • Patients will undergo the standard care at the burn center at which they are treated without the liposuction or ADRC injection
    • Patients enrolled in the RELIEF Trial will be assigned to these two arms at random using a 2:1 randomization such that two patients will be enrolled in the ADRC arm for every patient enrolled in the control arm
      • Selection into the two arms will be random (like throwing dice)
    • Patients in both groups will be asked questions about their skin graft healing (for example: How itchy is it? How painful?) at different times over a year following treatment. The Study Investigators will also perform non-invasive, non-painful measurements of key properties of skin such as how flexible it is, how well it works, and how discolored it is.
    • The study will pay for travel costs for the patient to return to the burn center for study-related reasons after they have been discharged from hospital

Details on some of the key endpoints of the RELIEF study can be found here.