Toxicological Analysis of a New Fibrin-Derived Dermal Scaffold (Dermoturk); Acellular and Combined with Stem Cells Forms

Abstract

Objective: We aimed to reveal the toxicological analysis of the newly developed fibrin-derived scaffold forms (DermoTurk) before human studies. Material and Methods: 42 male Albino Wistar rats were used. Two of them were used to produce mesenchymal and epidermal stem cells. Forty rats were divided into five groups, each consisting of 8 rats; the acellular scaffold applied group as Group-1, the mesenchymal stem cells added scaffold used group as Group-2, the MSCs and epidermal stem cells-added scaffold applied group as Group-3, MSCs- and epidermal stem cells-added scaffold applied outbred group as Group-4 and control as Group-5. The changing of laboratory tests in the groups was evaluated five days before application and on the 7th and 40th days. After the autopsy performed on the 40th day of the study, rats’ organs and scaffold implanted skin area were evaluated histologically. All the results of the groups were compared. SPSS 22.0 was used for analyses. P <0.05 was accepted as statistically significant. Results: There were no differences between the groups in terms of laboratory results. Histologically, a mild-grade foreign body reaction against the DermoTurk was found in all groups; this reaction was less in groups 3 and 4 with the richest stem cells. Conclusion: This study revealed that DermoTurk is safe in rats. It could be an important alternative to skin substitutes, with stem cells or alone. Human studies for clinical efficacy should be carried out.