Vericel Corp. (VCEL)

[lasers]

Session C-009 - Reconstruction
70 - Cultured Epidermal Autografts (CEA) for Coverage of Large Burn Wounds in Pediatric and Adult Patients, 1989-2015
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March 23, 2017, 10:00 - 12:00 PM Independence Ballroom
Authors
W. Hickerson, MD, FACS, T. McKeen, None, J. Fisher, None, A. Botto-van Bemden, PhD
The University of Tennessee, Memphis, TN; Vericel, Cambridge, MA
Abstract
Introduction: CEA have been used to treat severely burned patients in the United States (US) and internationally since 1988. In 1996, the FDA determined that manipulated autologous cell-based products, including CEA, require regulatory oversight, limiting commercialization of CEA by designating it a humanitarian use device (HUD). In 1999, an application for use of CEA was submitted to the FDA including information on 552 patients in the CEA Tissue Repair (GTR) database treated between 1989 and 1996. The application was approved in 2007, granting an indication for treatment of patients with deep dermal or full thickness burns of ≥30% total body surface area (TBSA). A condition of FDA approval was the creation of a tracking database (the CEA Medical Device Tracker [EMDT]) to collect information on all patients treated with CEA in the US. The objective of this analysis was to report the number of severely burned patients treated with CEA where the characteristics and outcomes of these patients were available.
Methods: Data collected included patient demographics, (gender, age, burn size [percentage of total body surface area (TBSA)]) and outcomes (survival at hospital discharge and final graft take). Source data were provided by the treating physician or attending burn team.
Results: As of June 2015, 953 patients were treated with CEA for severe burns (34% [325/953] pediatric; 66% [628/953] adult). The mean TBSA was 67.3% (SD 17.48), median graft take at discharge was 75%, and overall survival to discharge was 84% (804/953). Survival rates were similar for pediatric and adult patients (88.8% vs 81.7%, respectively).
Conclusions: Cultured epidermal autografts provide an alternative or adjunct to conventional split-thickness skin grafting for treating large burn wounds. The final median graft take of 75% and 84% overall survival rate provides optimism for continuing to use CEA in critically burned pediatric and adult patients.
Applicability of Research to Practice: We believe that this is the largest dataset of burn patients treated with CEA, including the largest dataset of pediatric patients, demonstrating the clinical benefit of using CEA for severely burned patients.

http://www.abstractsonline.com/pp8/#!/4303/presentation/88