<h1>Safety Approach</h1>

<h1>Safety Approach</h1>

<li>Safety and security is essentially important when setting up a system related to Medicine and Health. Taking the famous quote of Hippocrates “Primum non necere – First, do not harm” into attention, we have designed our system based on this principle by implementing body’s similar biological properties and non-reactive systems. Besides having the ability to manually terminate the system, we have also invented a safety mechanism in the possible course of adverse effects. Additionally, new ideas and editions have arised for our project’s safety as well as a future plan which will improve the systems security features and the potential of its application.</li>

<li>Safety and security is essentially important when setting up a system related to Medicine and Health. Taking the famous quote of Hippocrates “Primum non necere – First, do not harm” into attention, we have designed our system based on this principle by implementing body’s similar biological properties and non-reactive systems. Besides having the ability to manually terminate the system, we have also invented a safety mechanism in the possible course of adverse effects. Additionally, new ideas and editions have arised for our project’s safety as well as a future plan which will improve the systems security features and the potential of its application.</li>

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First of all, autologous proteins and genes present in the body have been used to maximize the safety of our project. Our body has a nature which reacts to foreign substances coming from the outside. As a consequence, harmful systemic reactions can have a high potential of occurrence and threaten one’s life. To avoid such conditions, we have selected several natural proteins present in our body for the clot dissolving processes of our system and antioxidant reactions such as tissue plasminogen activator or superoxide dismutase.

First of all, autologous proteins and genes present in the body have been used to maximize the safety of our project. Our body has a nature which reacts to foreign substances coming from the outside. As a consequence, harmful systemic reactions can have a high potential of occurrence and threaten one’s life. To avoid such conditions, we have selected several natural proteins present in our body for the clot dissolving processes of our system and antioxidant reactions such as tissue plasminogen activator or superoxide dismutase.

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<li>Secondly, our project intends to use autologous cells obtained from the patient. This will prevent adverse effects of cell therapy or cell replacement which is similar to organ transplantation. Auto-immune reactions may damage patient’s health and should be taken into account. Autologous eukaryotic cell engineering allows us to manipulate the body conditions easily and inhibits possible natural body system interference.</li>

<li>Secondly, our project intends to use autologous cells obtained from the patient. This will prevent adverse effects of cell therapy or cell replacement which is similar to organ transplantation. Auto-immune reactions may damage patient’s health and should be taken into account. Autologous eukaryotic cell engineering allows us to manipulate the body conditions easily and inhibits possible natural body system interference.</li>

<li>For clinical use and application, we are required to add new features in order to manage and monitor our therapy. To make this possible, we have designed our parts under tetracycline regulatory operon which interacts with the tetracycline antibiotic. This interaction results in the inhibition of our desired proteins production. Therefore clinician may use this as an advantage to stop the treatment when necessary. In the section of our Future Plan, considering the need of a treatment control, we also propose to add a feature into our design which will measure the quality and process of our treatment; hence helping us to establish a safe treatment.</li>

<li>For clinical use and application, we are required to add new features in order to manage and monitor our therapy. To make this possible, we have designed our parts under tetracycline regulatory operon which interacts with the tetracycline antibiotic. This interaction results in the inhibition of our desired proteins production. Therefore clinician may use this as an advantage to stop the treatment when necessary. In the section of our Future Plan, considering the need of a treatment control, we also propose to add a feature into our design which will measure the quality and process of our treatment; hence helping us to establish a safe treatment.</li>

<li>During the progression of our design, we became aware that tissue plasminogen activator (tPA) is actually an anticoagulant used in clinics frequently. Therefore, this may predispose the risk of interference with other medications yet also increase the risk of some complications such as spontaneous bleeding. However, by adding the monitoring features and enhancing the stabilization of our part’s local effects, we can forestall these adverse effects. tPA is modelled to determine the amount of protein transported to the outside of cells. We plan to compare this with the minimal amount that is required to result in the body being adversely effected. According to our predictions, the engineered cells would synthesize enough protein to dissolve the clot we target; but this effect will remain local. Despite our results, we are still in need of extra data to analyze how synthetic tPA and other medications will behave. Nevertheless, this information can only be obtained from clinical trials.</li>

<li>During the progression of our design, we became aware that tissue plasminogen activator (tPA) is actually an anticoagulant used in clinics frequently. Therefore, this may predispose the risk of interference with other medications yet also increase the risk of some complications such as spontaneous bleeding. However, by adding the monitoring features and enhancing the stabilization of our part’s local effects, we can forestall these adverse effects. tPA is modelled to determine the amount of protein transported to the outside of cells. We plan to compare this with the minimal amount that is required to result in the body being adversely effected. According to our predictions, the engineered cells would synthesize enough protein to dissolve the clot we target; but this effect will remain local. Despite our results, we are still in need of extra data to analyze how synthetic tPA and other medications will behave. Nevertheless, this information can only be obtained from clinical trials.</li>

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