Regenerative Medicine’s Fountain of YouthCompanies / BioTech Jan 24, 2016 - 04:04 AM GMT
Aubrey de Grey a biomedical gerontologist, predicted that the first person to live to a thousand has already been born. According to de Grey the key may lie in the field of regenerative medicine.
The Webster dictionary defines biological regeneration as “the restoration or the growth by an organism of organ or tissue, that have been lost, removed or injured.”
Dr. William Haseltine CEO of Human Genome Sciences, believes thatregenerative medicine is about assisting the body to heal itself. Dr. Haseltine coined the term "regenerative medicine," to describe the expected medical revolution that, in his view, could lead to human immortality.
Stanford Universities Dr. Helen Blau wrote that the goal of regenerative
medicine is to restore form and function to damaged tissues.
I think we can decide for ourselves that regenerative medicine means replacing, engineering or regenerating human cells, tissues or organs with the goal being to re-establish normality for conditions that currently are beyond repair.
“Cell therapy uses living cells as treatments. Its potential to cure or transform serious medical conditions lies in the nature of cells and their ability to interact with the body at levels of complexity many orders of magnitude greater than conventional drugs. Regenerative medicine is focused on the regeneration of tissues and organs using all the different therapeutic platform technologies available: small molecule drugs, biologics, medical devices and cells. Stem cell technologies, cell therapy and regenerative medicine are closely entwined and will ultimately transform the practice of medicine from today’s model of continual interventions to single
treatment cures.” Following Through: Realizing the Promise of Stem Cells, KPMG
Stem cells are the foundation for every organ and tissue in your body.
Stem cell research is paving, or leading the way for the hugely transformative and disruptive potential of regenerative medicine.
There are many different types of stem cells that come from different places in the body or are formed at different times in our lives.
All stem cells can self-renew – clone themselves - and differentiate, meaning they can develop into more specialized cells.
Embryonic stem cells
Embryonic stem cells are obtained from the inner cell mass of the blastocyst, a mainly hollow ball of cells that, in humans, forms three to five days after an egg cell is fertilized by a sperm. Embryonic stem cells are pluripotent, meaning they can give rise to every cell type in the fully formed body, but not the placenta and umbilical cord.
Tissue-specific stem cells
Tissue-specific stem cells (also referred to as somatic or adult stem cells) are more specialized than embryonic stem cells. Typically, these stem cells can generate different cell types for the specific tissue or organ in which they live.
Induced pluripotent stem cells
Induced pluripotent stem (iPS) cells are cells that have been engineered in the lab by converting tissue-specific (somatic/adult) cells, such as skin cells, into cells that behave like embryonic stem cells.
Treatments include both in vivo and in vitro procedures:
- In vivo - studies and trials performed inside the living body in order to stimulate previously irreparable organs to heal themselves
- In vito - treatments are applied to the body through implantation of a therapy studied inside the laboratory
Sernova Corp TSX.V – SVA
For the past 25 years, scientific laboratories around the world, with specialty trained experts in cell technologies, were learning the processes for how the body turns starting generalized stem cells into the mature functional cells.
Recent scientific advances have turned these scientists towards developing therapeutic cells to treat diseases such as Diabetes and Hemophilia. If successful these technologies have the ability to treat millions of patients unlike the currently available donor cells.
The ultimate goal of regenerative medicine for technologies that produce proteins or hormones as therapeutics, is to develop an unlimited supply of safe and efficacious therapeutic stem cells placed, in a simple procedure, within the body in a cell friendly and retrievable medical device, while being protected from immune system attack.
When the time came, Sernova Corp was determined to be in the forefront of such technologies with strong proof of concept on their therapeutic device with donor therapeutic cells within.
Knowing the importance of these developments, back in 2009, Sernova began working on, and patented, a proprietary, scalable, implantable medical device, their Cell Pouch™ that creates a natural environment for the survival and function of therapeutic cells.
The following examples are two diseases that regenerative medicine for technologies that produce proteins or hormones as therapeutics has the potential to cure and what the current state of treatment looks like.
Hemophilia A - Occurs in about 1 in 5,000 births. Currently, the number of people with hemophilia in the United States is estimated to be about 20,000, an estimated 400,000 people worldwide are living with hemophilia and only 25% receive adequate treatment.
Hemophilia is passed from parents to children. According to the U.S. Centers for Disease Control and Prevention, hemophilia occurs in approximately one in 5,000 live births. Even though this is an inherited disease, approximately one-third of the cases occur due to spontaneous gene mutation.
Hemophilia is a rare bleeding disorder in which blood doesn’t clot normally due to the lack of sufficient blood clotting factor. Clotting factor is a protein required for blood clotting to occur normally. These proteins work with platelets i.e. small blood cell fragments that form in the bone marrow, to help the blood clot.
There are several types of hemophilia, such as, hemophilia A, hemophilia B (commonly known as Christmas disease) and hemophilia C. Hemophilia A is the most common type of the disorder and is caused due to insufficient clotting factor VIII. Hemophilia A is four times more common than hemophilia B (US$2 billion market), and more than half of the patients with hemophilia A have a severe form of hemophilia.
Hemophilia A patients receive prophy-laxis factor replacement therapy. Prophylactic therapy (prevention therapy) involves three infusions of Factor VIII each week at the hospital at a cost of about $260,000 each year.
The broader hemophilia A&B market is US$10 billion and is expected to grow to US$13 billion by 2020.
The European Commission’s Horizon 2020 program has just awarded a $5.6M Euro ($8.5M CAD) grant to the HemAcure consortium. The consortium consists of Sernova Corp and five European academic and private partners to advance development of a GMP clinical grade Factor VIII releasing therapeutic cell product in combination with Sernova’s Cell Pouch(TM) for the treatment of severe hemophilia A.
The product being developed by the HemAcure consortium is expected to be highly disruptive to the current standard of care treatments for hemophilia A.
The reviewof the HemAcure grant proposal stated the following:
“Participation of the third country partner (Sernova Corp) is essential for carrying out the (program). This is justified by the fact that the partner in question is the one who possesses the technology that will be the basis of the whole proposal, and which will perform all the in vivo studies. Sernova uses a scalable, contract manufactured, proprietary patented worldwide implantable medical device (Cell Pouch) transplanted with therapeutic cells. (It) has been in development for more than six years and has shown success in multiple small and large animal preclinical models and is now in a clinical trial for another therapeutic indication. This Cell Pouch device is the only such device that when implanted under the skin is proven to become incorporated with blood vessel enriched tissue-forming chambers for the placement of therapeutic cells. This implies that the Canadian partner (Sernova) is an essential partner for the success of this project.”
HemAcure is the name of the consortium developing a product for hemophilia A. This project has received funding from the European Union's Horizon 2020 research and innovation program under grant agreement No 667421. The consortium members include the University Hospital Wurzburg (Coordinating Institute), Integrierte Management Systeme IMS e.K., Universita del Piemonte Orientale “Amedeo Avogadro,” Loughborough University, GABO:mi Gesellschaft für Ablauforganisation: milliarium mbH & Co. and Sernova Corp. The main objective of the HemAcure project is to develop and refine the tools and technologies for a novel ex vivo prepared cell based therapy within Sernova’s prevascularized Cell Pouch to treat this bleeding disorder that should ultimately lead to improved quality of life of the patients.
The World Diabetes Foundation estimates that there will be 438 million people with diabetes by the year 2030. The global market for products in the management of diabetes is on pace to grow to over $114 billion by 2018.
The top 10 companies producing diabetes medications raked in about $62 billion in global sales in 2014, up 5.1% from the previous year.
“Anti-diabetic products include glucose meters, lancets, test strips, continuous blood glucose meters, insulin, insulin pumps, syringes and other insulin delivery devices and anti-diabetic drugs. The bulk of product revenues come from three segments - test strips, insulin and anti-diabetic drugs - which will remain the largest sources of product revenues over the next ten years. The most significant growth, however, will come from the nascent segment of continuous blood glucose monitors, which provide significantly added clinical benefit at only a modestly higher cost compared to standard blood glucose meters.”Analyzing the Global Diabetes Market, researchandmarkets.com
From a recently published paper ‘Diabetes Is Reversed in a Murine Model by Marginal Mass Syngeneic Islet Transplantation Using a Subcutaneous Cell Pouch Device’ comes the following…
"The emerging field of cellular transplantation involving human-derived engineered stem cells is providing potential therapeutic treatment options to benefit far more patients than donor cells can provide, especially for diseases, such as type 1 diabetes. The future of these therapies, aside from manufacturing aspects to improve safety, depends on a suitable environment for the cells and cellular engraftment.
The current study demonstrates that the CP (Cell Pouch) placed in the subcutaneous space provides a suitable environment for therapeutic islets as effective as the renal subcapsular transplantation, at least in the murine model. Furthermore, in subsequent assessment, it has been shown that the CP scaled for human use can provide glucose control in large animal transplantation models of diabetes (Sernova unpubl. results).
Thus, the CP system placed subcutaneously also meets the requirements for scalable human islet transplantation. Further studies, which include evaluation in the clinic are now required to demonstrate that the CP can indeed serve as a potential alternative to clinical intraportal islet transplantation, and provide a vehicle for future placement of alternate cellular therapies in replacement and regenerative medicine. Indeed, the data presented herein in addition to Sernova's large animal data (unpublished) formed the experimental basis of a first-in-human trial using identical CP technology currently underway in patients at the University of Alberta."
Results from the afore mentioned first-in-human trial using SVA’s Cell Pouch(TM) were impressive…
“Encouraging early results up to 30 days post-islet transplant were presented at the International Pancreas and Islet Transplantation Congress in September, 2013. These results showed after implantation under the skin, the Cell Pouch is safe and biocompatible. Following islet transplantation, the islets living within a natural tissue matrix were supported with a rich supply of blood vessels, similar to the pancreas. Of further importance, the islets were shown to make insulin, somatostatin and glucagon – key hormones in the control of blood sugar levels. The study was conducted with Dr. James Shapiro as principal investigator at the University of Alberta Health Sciences Centre in Edmonton, Alberta.”
Let’s visit SVA’s website from where we get the following…
“In July, 2014 Sernova entered into an agreement with the University Health Network of Toronto (UHN) to gain access to worldwide, exclusive rights to certain patent-pending technologies. developed by distinguished UHN researchers, Dr. Cristina Nostro and Dr. Gordon Keller, for the advancement of insulin-producing stem cells for the treatment of patients with insulin-dependent diabetes.
A product development program has been designed to advance the technologies from preclinical proof-of-concept studies through to human testing on an expedited basis.
Sernova believes the proprietary product – insulin producing stem cells, protected locally from immune system attack and placed within Sernova’s prevascularized Cell Pouch(TM) – has the potential to provide a significant break-through in the quality of treatment for the tens of millions of people suffering from insulin-dependent diabetes, following successful preclinical and clinical testing. Such individuals could essentially be liberated from their current onerous regime of daily blood glucose testing and insulin administration delivered through injections or electronic means which is expected to materially improve their quality of life while also reducing short term and longer term health care costs.”
Harnessing the power of stem cells to repair or replace cells, tissues or organs that are damaged by trauma or disease means we are entering an era where treatments for some of the world's most devastating diseases are developed.
Many companies have stem cells, most even have the ability to manufacture them for various indications. In your author’s opinion, only Sernova Corp TSX.V - TSX has a proven safe and biocompatible therapeutic device to host these cells within the human body.
The transformational potential of stem cells, placed within Sernova’s prevascularized Cell Pouch(TM), to cure diabetes and hemophilia could:
- Treat diseases in a much better way than traditional drugs/treatments
- Significantly improve the quality of patient’s lives
- Offer a faster, more complete recovery with significantly fewer side effects or risk of complications
- Reduce the cost of healthcare
- Prevent premature mortality
- Bring significant indirect economic benefits not only to patients but society as a whole
Lab manufactured therapeutic stem cells hosted in the human body, in SVA’s prevascularized Cell Pouch(TM), monitoring, regulating, manufacturing and secreting the necessary hormones, factors and proteins to control diabetes and hemophilia is a milestone accomplishment.
So does Sernova have Ponce De Leon’s fabled Fountain of Youth? No of course not, but it would be hard to argue against my position that Sernova Corp., and the regenerative medicine sector as a whole, has taken a huge step along that road if upcoming human trials are successful.
It is an exciting time for regenerative medicine, the health care sector, patients, and yes investors, with many disruptive innovations on the near horizon.
Sernova Corp TSX.V - SXA is on my radar screen. Is it on yours?
If not, maybe it should be.By Richard (Rick) Mills
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