Safety and feasibility of allogenic keratinocyte sheet application for deep second degree burn; SAFEALLOSHEET: phase I clinical trial.

AIMS: Deep second-degree burns often require autografting, but donor-site limitations highlight the need for alternative biological coverings. This study evaluated the safety and feasibility of allogeneic cultured keratinocyte sheets for acute burn wounds.

PATIENTS AND

METHODS

Five patients with 20-50% total body surface area burns were enrolled. A 60 cm2 wound site in each patient received the sheet, while the remaining areas were treated with standard autologous grafts. Patients were followed for 6 months. Primary endpoints were safety and feasibility; secondary endpoints included graft take, wound closure time, and scar quality assessed by Vancouver Scar Scale (VSS) and Patient and Observer Scar Assessment Scale (POSAS). Histopathology was performed at baseline and 6 months.

RESULTS

No serious adverse events occurred; only minor, self-limited reactions were observed. Keratinocyte sheets demonstrated near-complete take without immune responses. Wound closure occurred within 1 month in two patients and by 3 months in the others. POSAS patient scores improved from 28.4 ± 9.8 to 19.2 ± 6.0, and observer scores from 21.2 ± 3.8 to 14.2 ± 5.1. VSS decreased from 5.0 ± 2.1 to 3.6 ± 2.4. Histology confirmed favorable epithelialization.

CONCLUSIONS

Allogeneic keratinocyte sheets were safe, feasible, and improved healing and scar quality.

CLINICAL TRIAL REGISTRATION: Iranian Registry of Clinical Trials (IRCT), https://irct.ir/trial/62833; identifier is IRCT20080728001031N31.