Graft of 3D bioprinted autologous minimally manipulated homologous adipose tissue for the treatment of diabetic foot ulcer.

Early human evidence such as case series or small samples is exploring possible benefits.

• Level A · Stronger Clinical Evidence
• Level B · Emerging clinical evidence with positive signals
• Level C · Early human research exploring benefits
• Level D · Scientific groundwork from lab and animal studies
• Emerging · Emerging topic under active research

Abstract (original English)

Introduction Adipose-derived stem cells are multipotent precursor cells with the ability to differentiate into cell lineages associated with the regeneration of tissues. Objective The authors investigated the efficacy of AMHAT with 3D bioprinting technology in DFU. Materials and methods Twenty patients were enrolled in a clinical prospective interventional pilot study. The primary endpoint was a reduction in the size of DFU, and the secondary endpoints were the epithelialization rate and amount of granulation of wound bed at weekly assessments. A bioprinter was used to produce AMHAT in the customized shape of DFU. The data were obtained using photography and computerized digital surface calculation. Results The mean wound size at the time of hospitalization was 7.529 cm2. All but one of the wounds were completely epithelialized at the ninth week. The mean wound areas decreased at weekly assessments for the first 7 weeks of treatment compared to the pre-application. When the mean decrease in the wound size was compared between consecutive weeks, there were decreases at each of the first 7 weeks. The mean time to the complete closure was 32.20±23.862 days. Conclusion These data indicate that AMHAT is beneficial in terms of ease of application, significant decrease in the wound surface area, no scarring compared to grafting, and full healing times.

Evidence level

Early human evidence such as case series or small samples is exploring possible benefits.

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