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Differentiating Factors of ELAD

Differentiating Factors of ELAD

Unlike other investigational therapies developed for acute liver failure in the past, we believe ELAD holds a unique combination of attributes:

• Biologically active. ELAD is a biologically active system that is designed to replicate many liver functions. The functional unit of the liver, the hepatocyte, is thought to be responsible for 500 or more biologic processes necessary for human life. Moreover, many processes of the liver occur at ever fluctuating rates in continuing response to the liver’s constantly changing biologic environment. As a result, we believe that an acellular solution to liver failure is unlikely to effectively replace lost liver function. Therefore a cellular approach, capable of replicating key biologic processes performed by a human hepatocyte, may be able to provide the requisite flexibility and breadth of function to sufficiently supplement liver function and improve survival in patients with acute liver failure.

• Human cellular allogenic therapy. ELAD is an allogeneic cell therapy based on our human C3A cells which confer a considerable advantage over animal cell (xenogeneic) therapies. Given the widespread availability of animal tissues, much work has been done on the use of animal liver cells, often derived from pigs, to treat humans with liver failure.  While immunological risk is always present in cellular therapy, the use of non-human animal tissues presents greater immunological risk compared to human cellular therapy. Humans possess naturally occurring antibodies that react with antigens on porcine cell surfaces. These antibodies can mount an immediate attack in the presence of porcine cells, causing these cells to rapidly lose function and die. Moreover, repeated treatments with a porcine cell may cause subsequent immune responses to become increasingly severe. The infusion of porcine enzymes into a patient’s blood stream also poses immunologic risk. We are not aware of any FDA-approved non-human animal-based cellular therapy for use in patients.

• Immortal C3A cells. Our C3A cells used in ELAD are derived from a human hepatoblastoma and are immortal. The cells retain many key functions of normal hepatocytes and they can be expanded and can survive a session of ELAD therapy often without needing to be replaced during treatment. Primary hepatocytes are the main cell in the liver and deteriorate rapidly when removed from the body. Hepatocytes cannot be grown outside the body as they de-differentiate and die in a short period of time because they cannot be expanded ex-vivo using current methodologies.  Hepatocytes are currently not suitable for a cellular regenerative approach or an ex-vivo cellular treatment approach, such as the ELAD System, which requires large amounts of hepatocytes.

• Commercially scalable. We have developed a proprietary, scalable production process to further development of our C3A cell line in our production facility in Shandong Jinan High-tech Zone. Each patient set of four cartridges contains a total of about 440 grams of cells and is grown in a production process that takes about six weeks. The process is very carefully controlled and is performed under ultra clean conditions to avoid contamination in our cGMP compliant production plant. The process is scalable by modular units.

• Minimal manipulation needed by site. Prior to shipment, ELAD cartridges are put into a dormant state and have up to 60 hours to be administered. When the hospital receives the cartridges, they are unpacked by our ELAD Specialists on site, placed on the bedside unit, flushed with saline and are ready to proceed with the patient therapy. Our immortalized C3A cells can remain metabolically active for the duration of anticipated patient therapy, often without the need for replacement, enhancing ease-of-use at the time of treatment and reducing the associated cost-of goods.