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

Résumé fourni par la source

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. 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. 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. Allogeneic keratinocyte sheets were safe, feasible, and improved healing and scar quality. Iranian Registry of Clinical Trials (IRCT), https://irct.ir/trial/62833; identifier is IRCT20080728001031N31. Burn injuries that damage the deeper layers of the skin often require skin graft surgery. In this procedure, healthy skin is taken from another part of the patient’s body to cover the wound. However, in patients with large burns, there may not be enough healthy skin available for grafting. This has led researchers to look for alternative ways to temporarily or permanently cover burn wounds and help them heal. In this study, we investigated whether sheets of laboratory‑grown skin cells (called keratinocytes) from donors could safely help treat burn wounds. Keratinocytes are the main type of cells found in the outer layer of the skin and play an important role in skin repair. Five patients with moderate to severe burns affecting 20–50% of their body were included in the study. In each patient, a small burn area was treated with the donor keratinocyte sheet, while the rest of the wounds were treated with the standard skin graft method. Patients were monitored for six months. We found that the keratinocyte sheets were safe and did not cause serious side effects or immune reactions. The treated wounds healed over time, and the appearance of the healed skin improved during follow‑up. Tissue examination also showed healthy skin regeneration. Overall, our results suggest that donor‑derived keratinocyte sheets may be a safe and promising option to support healing in burn wounds, especially when there is limited healthy skin available for traditional grafting.

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