What makes Aril® different?
Under the guidance of clinical and industry experienced experts, Aril manufacturer Seed Biotech’s core competency is based on a novel decellularization and stabilization process. Seed Biotech is uniquely able to prepare highly variable biological materials to deplete biomaterials of cell and cellular contents without imparting unintentional alterations to the extracellular matrix comprised of soluble and non-soluble bioactive constituents. Aril® processing eliminates potentially inflammation-causing cells of the chorion and epithelium, with greater than 95% reduction in DNA.
Risks for Transmission from Residual Donor DNA
There is inherent delay from the time a communicable disease first presents itself, to the time it is regarded as a risk to the general population, and finally to the time it achieves national/global awareness. Clinical presentation of the disease with symptoms will occur in addition to events of transmission where presentations of symptoms have not been observed. Prior to awareness and national recognition of the risk, donors could potentially suffer or carry such diseases and therefore, even through required and exhaustive screening and testing measures, the time factor and state of knowledge limits what can reasonably be anticipated from the effectiveness of such measures.
Challenge of the time delay in disease transmission, awareness, and recognition
It is likely we will occasionally if not continually have to face the challenge of not having the proper tools to detect diseases in tissue donors, even once awareness and recognition, and more importantly the need, occurs. We face this exact challenge currently in association with prion based disease transmission and even with the implementation of best and required practice, we know that our efforts are inadequate to detect if and when donors have disease causing cellular prion proteins. Without any additional options available, there is only one pathway to mitigate theses clinically relevant risks.
As such, Seed Biotech purifies donated tissue materials depleting them of cell and cellular contents and batch verifies the material as suitable for use. In contrast to current leading manufacturers of human placental tissue products that intentionally provide product configurations that retain donor devitalized cells, Seed Biotech has established and recognizes the criticality to employing an effective decellularization process to donated human tissues intended for further use as a raw material in clinically used products, and believes there are no other production methods available to achieve a comparable and acceptable safety profile for such products nor a clinical advantage for doing so.1
Seed Biotech believes they will continue to be differentiated from competitors that DO employ decellularization production methods because this novel process technology was developed to achieve normalization of a highly variable starting material consistently to a pre-established required state of purity without alteration or loss to the quality of the native extracellular matrix material.
Residual DNA Impacts Performance
Exacerbated or chronic inflammation and undesirable fibroblast activity are potential additional consequences of implantation of product containing non-self low molecular weight peptides.2,3,4,5 The presence of residual genetic DNA of donor cells in allograft tissues would be anticipated to have an additive effect on normal inflammation occurring as a part of the natural wound healing process. Additionally, it has been shown that the presence of residual DNA is correlated with increased fibroblast activity, which is recognized to be associated with fibrotic tissue formation.
Measurement Metrics of Clinical Benefit Potential
Seed Biotech does not neglect clinically relevant properties regarded to be related to the quality and effectiveness of the end products. The knowledge regarding the mechanisms of action of tissue products were equally prioritized during the development of the process methods and process and product development approach Seed Biotech uses for the manufacture of tissue as a raw material. The process was verified to preserve the surface chemistry, architecture, composition, geometry, and organization of the extracellular matrix (ECM) of the material.
Evaluation of paired samples of native and Seed Biotech processed human placental tissue demonstrate the process does not induce alterations to the structure, composition, chemistry and organization of human placental tissue ECM. Evaluations focused on much more than showing just preservation of the ECM soluble constituents, but more importantly, post process preservation of the numerous critical properties of the ECM. These properties are recognized as critical to cell activity and tissue cascades, including the material interface (surface chemistry and surface morphology), structure, composition, and organization are critical drivers of cell activity.5,6,7,8,9,10,11 The ECM of connective tissues acts as a reservoir of bioactive peptides including TIMPS, growth factors, cytokines, and glycosaminoglycan’s and the basement membrane interface acts as a substrate that supports cellular adhesion, transplanar migration and proliferation. When the ECM origin is a neotenic or juvenile biological connective tissue, such as placental tissue, and effective preparation and preservation occurs, inherent properties unique to neotenic tissues can be used for potential clinical benefit.6,11
Seed Biotech innovations are driven by a focus on improving clinical outcomes, specifically reduction in undesirable secondary clinical symptoms common to surgical intervention, such as infection and loss of ROM fibrosis, and improving frequency and extent of quality tissue regeneration vs. fibrotic tissue post-surgery, and vascular tissue injury. There are numerous considerations incorporated into the design of Aril® -- from product shape to packaging – each intended to maximize suitability for use, potential for clinical benefit, and above all safety.