EpiSC-Enhanced Composite Grafts for Skin Reconstruction

Full-thickness skin defects caused by burns, ulcers, scars, trauma, or other conditions can result in functional impairment, visible scarring, and substantial reconstructive challenges. Conventional split-thickness skin grafting is widely used for wound closure, but graft contraction, delayed vascularization, donor-site morbidity, and suboptimal scar quality may limit clinical outcomes.

Tissue-engineered skin combines a supporting matrix with viable cells to more closely reproduce the structure and function of native skin. Epidermal stem cells (EpiSCs) are of particular interest because of their potential roles in epithelial regeneration, angiogenesis, immune modulation, and extracellular matrix remodeling. However, conventional cell-based approaches may require prolonged in vitro culture and specialized facilities, limiting their routine clinical use.

In this study, the investigators used a standardized intraoperative cell isolation system to prepare an autologous EpiSC-enriched basal cell suspension from residual fragments of split-thickness skin graft obtained from the participant during surgery. The cell suspension was prepared and applied immediately without prolonged in vitro expansion.

In the standard-treatment group, the prepared wound bed was covered with an acellular dermal matrix followed by a split-thickness skin graft. In the cell-therapy group, the EpiSC-enriched suspension was first applied to the wound bed, followed by placement of the acellular dermal matrix. A second application of the cell suspension was then made to the surface of the matrix before the split-thickness skin graft was placed. Postoperative wound care was performed using the same general protocol in both groups.

The study was designed to evaluate whether adding an intraoperatively prepared autologous EpiSC-enriched cell suspension to conventional composite grafting could improve the quality of full-thickness wound repair.

Inclusion criteria

Patients requiring skin grafting for full-thickness skin defects caused by burns, ulcers, scars, or other conditions.

Wound area greater than 9 cm². Willing to participate in the clinical trial, provide written informed consent, and comply with follow-up requirements. For minors, consent was provided by a legal guardian.

Mentally capable of understanding and following medical instructions.

Exclusion criteria

Known allergy to trypsin or collagen. Acute systemic infection, uncontrolled severe disease, or serious organ dysfunction.

Planned pregnancy during the study period or within 6 months after skin grafting.

Malignant tumors, autoimmune diseases, or use of high-dose glucocorticoids, defined as ≥40 mg prednisone per day or an equivalent dose for ≥2 weeks.

Positive bacterial culture indicating wound infection. Limb vascular neuropathy. Expected inability to survive during the study period. Participation in another clinical study within the previous 12 weeks.