Oral Presentation ANZBA Annual Scientific Meeting 2025

Real-World Success in Acute Full-thickness Wounds Using the Next-Generation Autologous Cell Harvesting Device (23004)

Carmen Flores 1 , Katie Bush 2
  1. Trauma and Acute Care Surgery, University Medical Center of Southern Nevada, Las Vegas, Nevada, United States
  2. Medical Affairs, AVITA Medical, Valencia, California, United States

Introduction:
The RECELL® Autologous Cell Harvesting Device (ACHD) enables point-of-care preparation of an autologous skin cell suspension (ASCS) from a small split-thickness skin sample, allowing treatment at expansion ratios up to 1:80. This significantly reduces donor site morbidity and has demonstrated clinical efficacy in burns and full-thickness wounds,1-4 with accelerated re-epithelialization compared to grafting alone.5-6

In 2024, a next-generation ACHD (NG-ACHD) was FDA-approved, offering improved standardization of ASCS preparation. This work presents preclinical data supporting biological equivalence of ASCS prepared with NG-ACHD versus ACHD and initial clinical outcomes when NG-ACHD was used in the treatment of acute full-thickness non-thermal injuries.

Methods:
Split-thickness skin samples (0.006–0.008”) harvested from full-thickness surgical discards were processed with ACHD or NG-ACHD (n=21 per group). Cell yield, viability, phenotype, aggregation, and regenerative capacity in a 3D skin model were assessed. Non-inferiority testing, including paired analyses, compared outcomes using ACHD as the reference. Additionally, a case series of trauma patients treated with NG-ACHD-prepared ASCS was analyzed for wound types, application methods, and clinical outcomes.

Results:
ASCS prepared with NG-ACHD was non-inferior to ACHD for all evaluated attributes. Both devices yielded high proportions of non-apoptotic (~80%) and single (~95%) cells with comparable phenotype profiles. NG-ACHD produced more consistent outcomes in total cell yield and total live cell yield with less inter-sample variability. In vitro, both ASCS types supported mature, stratified epidermis formation. Initial clinical cases treated with NG-ACHD included various acute full-thickness non-thermal injuries managed with ASCS in conjunction with meshed autograft. All patients demonstrated excellent graft take and wound closure.

Conclusions:
NG-ACHD produces ASCS comparable in quality to the original device. Early clinical experience in trauma wound management suggests excellent outcomes, supporting broader use of this next-generation technology.

  1. Sood R, Roggy DE, Zieger MJ, Nazim M, Hartman BC, Gibbs JT. A comparative study of spray keratinocytes and autologous meshed split-thickness skin graft in the treatment of acute burn injuries. Wounds. 2015;27(2):31-40.
  2. Holmes Iv JH, Molnar JA, Carter JE, et al. A Comparative Study of the ReCell® Device and Autologous Spit-Thickness Meshed Skin Graft in the Treatment of Acute Burn Injuries. J Burn Care Res. 2018;39(5):694-702. doi:10.1093/jbcr/iry029
  3. Holmes JH 4th, Molnar JA, Shupp JW, et al. Demonstration of the safety and effectiveness of the RECELL® System combined with split-thickness meshed autografts for the reduction of donor skin to treat mixed-depth burn injuries. Burns. 2019;45(4):772-782. doi:10.1016/j.burns.2018.11.002
  4. Henry S, Mapula S, Grevious M, et al. Maximizing wound coverage in full-thickness skin defects: A randomized-controlled trial of autologous skin cell suspension and widely meshed autograft versus standard autografting. J Trauma Acute Care Surg. 2024;96(1):85-93.
  5. Navarro FA, Stoner ML, Park CS, Huertas JC, Lee HB, Wood FM, Orgill DP. Sprayed keratinocyte suspensions accelerate epidermal coverage in a porcine microwound model. J Burn Care Rehabil. 2000 Nov-Dec;21(6):513-8.
  6. Collins ML, Williams D, Pierson BE, et al. Wound Healing and Scar Patterning After Addition of Autologous Skin Cell Suspension to Meshed Grafts. J Surg Res. Published online September 13, 2024. doi:10.1016/j.jss.2024.08.006