Comparative Analysis of Commercially Available Extracellular Matrix Soft Tissue Bioscaffolds

Decellularized extracellular matrix (dECM) products are widely established for soft tissue repair, reconstruction, and reinforcement. These regenerative biomaterials mimic native tissue ECM with respect to structure and biology and are produced from a range of tissue sources and species. Optimal source tissue processing requires a balance between removal of cellular material and the preservation of structural and biological properties of tissue ECM. Despite the widespread clinical use of dECM products there is a lack of comparative information on these products. This study provides a comparative analysis of 12 commercially available dECM products. One group of products consisted of materials intended for dermal repair including ovine forestomach matrix (OFMm), porcine peritoneum (PPN), porcine placenta (PPC), and porcine small intestinal submucosa (SISu). The second group, intended for load-bearing reconstruction, consisted of material derived from ovine forestomach matrix (OFMo), porcine urinary bladder matrix (UBM), porcine small intestinal submucosa (SISb and SISz), human dermis (ADM), porcine dermis (PADM), and fetal/neonatal bovine dermis (BADM). A minimally processed product consisting of human placental tissue was included as a control. Products were compared histologically and by agarose gel electrophoreses to assess structural features and decellularization. Structurally, some dECM products showed a well-preserved collagen architecture with a broad porosity distribution, whereas others showed a significantly altered structure compared with native tissue. Decellularization varied across the products. Some materials surveyed (OFMm, PPN, PPC, OFMo, UBM, SISz, ADM, PADM, and BADM) were essentially devoid of nuclear bodies (mean count of <5 cells per high-powered field [HPF]), whereas others (SISu and SISb) demonstrated an abundance of nuclear bodies (>50 cells per HPF). Pathology assessment of the products demonstrated that OFMm, OFMo, and PADM had the highest qualitative assessment score for collagen fiber orientation and arrangement, matrix porosity, decellularization efficiency, and residual vascular channels scoring 10.5 ± 0.8, 12.8 ± 1.0, and 9.7 ± 0.7 out of a maximum total score of 16, respectively. This analysis of commercially available dECM products in terms of their structure and cellularity includes 12 different commercial materials. The findings highlight the variability of the products in terms of matrix structure and the efficacy of decellularization. Impact Statement The comparative analysis of 12 commercially available decellularized extracellular matrix (dECM) products reveals a spectrum of structural integrity and decellularization efficacy crucial for soft tissue repair and reconstruction. Although some dECM materials exhibit well-preserved collagen architecture and minimal cellularity, others display significant alterations and residual cellular components. Notably, products derived from ovine forestomach matrix, porcine peritoneum, and porcine placenta demonstrate optimal decellularization and structural fidelity, promising improved clinical outcomes. This study underscores the imperative for comprehensive assessments of dECM products, shedding light on their variable quality and potential implications for tissue regeneration. Such insights lay the groundwork for informed clinical decision-making and advancements in regenerative medicine.