Technology

    Sernova's Cell Pouch System™


    Sernova’s Cell Pouch System™ is a novel implantable and scalable medical device which forms a natural environment in the body for the housing and long-term survival and function of therapeutic cells. These therapeutic cells release necessary proteins or hormones missing from the body to treat chronic diseases as an alternative to daily administration of drugs.

    Sernova’s Cell Pouch System™ combined with therapeutic cells can provide a convenient, safe and effective long-term therapeutic option for patients with chronic disease who seek to improve their quality of life. The Cell Pouch™ has been contract manufactured according to strict regulatory guidelines (ISO13485 specifications), and it is currently in clinical trials in patients with diabetes.


    Safety

    The Cell Pouch™ is manufactured from medical-grade FDA approved materials and is biocompatible and safe as demonstrated in multiple preclinical studies and ISO10993 biocompatibility studies.

    Efficacy

    The Cell Pouch™, when transplanted with insulin producing islets, has demonstrated efficacy in three different small and large animal transplantation models (isograft, autograft and allograft) of diabetes, where animals achieved sustained glucose control.

    Convenience

    The Cell Pouch™ for humans is approximately the size of a business card and is placed under the skin in a simple procedure. Both the implantation of the Cell Pouch™ and transplantation of islets have been demonstrated in the clinic to be rapid procedures. Transplanted islets within the Cell Pouch System™ can produce insulin naturally through a feedback system linking glucose levels to the release of insulin; this may reduce or eliminate the need for insulin injections



    Immune Protection

    Immune protection of cells within the Cell Pouch System™


    Sernova has multiple options for protection of cells within the Cell Pouch from immune system attack. The cells can be protected using medications that protect the cells from immune attack. There are polymer encapsulation technologies to protect the cells from the immune system. There are also developing methodologies to make cells unrecognizable to the immune system. These latter two technologies may not require medications to protect the cells from the immune system.

    As one example below is a summary of microencapsulation technology to protect the cells within the Cell Pouch

    • The Cell Pouch™ is an implantable, scalable device, consistently shown capable of housing islets within a natural tissue matrix supported by microvessels
    • Microencapsulated cells are housed in a polymer sphere with pores to keep out immune cells but allowing the flow of nutrients and insulin
    • Microvessels within the Cell Pouch™ associate with encapsulated cells
    • This approach is expected to reduce or eliminate the need for anti-rejection drugs and provide a safe environment for unlimited sources of cells
    • Preclinical Safety, encapsulated islet survival and efficacy have been shown in a large animal immune competent diabetes model within the Cell Pouch™
    • The Cell Pouch, which creates an ideal vascularized tissue environment for cells plus local microencapsulation of cells within the Cell Pouch is expected to provide a non-toxic platform for the treatment of chronic diseases.

    Indications

    Chronic debilitating diseases such as diabetes, parathyroid hormone deficiency, haemophilia and Parkinson’s disease result from the lack of cellular production of a certain protein or hormone. Current treatments to replace these factors often do not maintain the appropriate levels of the factors resulting in a lack of sustained efficacy, and may lead to serious and life-threatening side-effects.



    Diabetes

    • Diabetes currently affects 246 million people worldwide. By 2025, it is expected to affect 380 million people (JDRF Canada)
    • The World Health Organization indicates five to ten percent of the health budget of a typical nation is spent on diabetes (WHO)
    • Approximately 10% of patients with diabetes are insulin-dependent (Type 1) (National Health Services, UK)
    • Approximately 27% of Type 2 patients take insulin injections to control their diabetes (American Diabetes Association)
    • Over 300, 000 Canadians live with Type 1 diabetes. Diabetes and its complications cost the Canadian economy more than $17.4 billion a year (JDRF Canada)
    • There are approximately 23.6 million patients with diabetes in the U.S., where healthcare costs for the treatment of diabetes exceeds $150 billion per year ( National Institute of Diabetes and Digestive and Kidney Diseases ) )
    • 92 million patients live with diabetes in China (BBC News, UK)
    • The standard of care for patients with reduced or missing critical hormones or proteins, such as insulin, is monitoring and trying to maintain appropriate levels through frequent injections. Chronic irregular swings in levels of these can result in serious acute and chronic side effects.
    A person living with diabetes

    The body’s blood sugar levels are controlled by islets in the pancreas which can release insulin in response to elevated sugar levels. Insulin then works to bring the sugar levels back to normal levels as the cells take up and use the sugar to function.

    In Diabetes, blood sugar rises to an abnormally high level because either the insulin producing islets become damaged or lost or because the cells in the body become insensitive to insulin.

    Diabetes has reached epidemic proportions around the world. Current treatments do not cure the disease but work to help control sugar levels to a certain degree.

    The current standard of care of patients with insulin dependent diabetes is insulin injections or insulin delivered through insulin pumps. Both of these do not produce tight control of glucose levels. Replacement of insulin producing islets through cell transplantation can be a feasible long-term treatment option, especially if the donor islets are protected locally from immune system attack.



    Haemophilia

    A person living with haemophilia

    Haemophilia A is the most common form of haemophilia and results from a deficiency of clotting Factor VIII to a level of less than 1% of the normal blood concentration. Haemophiliacs have prolonged bleeding which in areas such as the brain can be fatal or inside joints can be permanently debilitating. Approximately 20,000 people in the United States have the moderate or severe form of haemophilia A, as well as approximately 2,500 in Canada and 10,000 in Europe. Though there is no cure for haemophilia A, it is currently controlled with regular injections of recombinant clotting Factor VIII. Annual costs for the treatment of the disease may range from $60,000 to $260,000 per patient for a total cost of between $2-4 billion per year in North America and Europe.

    Development of a product capable of producing an effective level of Factor VIII within the Cell Pouch™ environment has the potential to provide haemophilia A patients with better protection against dangerous episodes of excessive bleeding and greatly reduce annual therapy costs.

    In September, 2013, Sernova and Medicyte GmbH have entered into a Material Transfer Agreement (MTA) to jointly evaluate the use of Medicyte's upcyte® cells in Sernova's Cell Pouch™ for the treatment of patients with haemophilia A.



    Other Indications

    Sernova’s technology may also provide a natural, safe and effective environment for the treatment of numerous chronic diseases such as haemophilia, human growth hormone deficiency, parathyroid hormone deficiency and Parkinson’s disease.



    Clinical Study

    Sernova is conducting a Phase I/II clinical study in subjects with diabetes; measures of safety and efficacy are the primary and secondary endpoints.