Richard (Rick) Mills
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As a general rule, the most successful man in life is the man who has the best information
The promise of regenerative medicine is to treat disease and injury by replacing, regenerating or rejuvenating various parts of the human body that have been damaged by chronic disease, traumatic injury, heart attack, stroke, or aging. Treatments include both in vivo (studies and trials performed inside the living body) and in vitro (treatments applied to the body through implantation of a therapy studied inside the laboratory) procedures.
After many years of research the potential for regenerative medicine to redress the increasing prevalence of degenerative chronic diseases and acute injuries is beginning to receive huge scientific and public interest.
And no wonder! Look at some of the things we can already do…
- Spina bifida suffers can now receive a bladder grown from their own cells.
- Researchers have bioengineered a human liver that can be implanted into mice.
- Heart disease affects the valves of the heart causing them to fail, we’ve already successfully grown heart valves from human cells.
- Researchers have regenerated kidney tissue that is able to clear metabiolites, reabsorb nutrients and produce urine both in vitro and in vivo in rats.
- Surgeons can now implant a tiny telescope within the eye helping restore some of the vision lost to end-stage age-related macular degeneration (AMD).
- A material developed from the small intestines of pigs - small intestinal submucosa (SIS) - is used for everything from reconstructing ligaments, closing hard-to-heal wounds and treating incontinence.
- Less complex organs such as the bladder and the trachea have been constructed from a patient's cells and scaffolds and successfully transplanted.
- Tissue-engineered vascular grafts for heart bypass surgery and cardiovascular disease treatment are at the pre-clinical trial stage.
- New approaches to revitalizing worn-out body parts include removing all of the cells (decellularization) from an organ, and infusing new cells (recellularization) to integrate into the existing matrix and restore full functionality.
“The first crop of simple stem cell therapies for regenerative medicine has reached widespread availability in the developed world. "Simple," because these therapies are on the level of transfusions. In most cases stem cells are obtained from the patient, then grown in a cell culture and the greatly expanded number of cells injected back into the body. New medicine doesn't get much simpler than that in this day and age. This is merely the start of a revolution in medicine, however, one will grow to become as large and as influential on health as the advent of blood transfusion or the control of common infectious diseases…Research continues, with a tone of excitement coming from the scientific community. They know they are onto something big.” Fightaging.org, Stem Cells, Regenerative Medicine, and Tissue Engineering
Some ongoing studies:
- Diabetics treated with stem cell therapies that grow new insulin making cells.
- Researchers are developing strategies to deliver proteins directly to the brain of stroke patients to stimulate stem cells and promote tissue repair.
- Halting the progression of ALS, amyotrophic lateral sclerosis (also known as Motor Neuron disease and Lou Gehrig’s disease) and multiple sclerosis (MS).
- Regrowing muscles in soldiers who were wounded in an explosion.
- Restoration of Factor VIII in hemophiliacs.
- The potential benefits of genetically enhanced stem cells in healing severe heart attacks.
It has to be pretty clear by now that regenerative medicine, although still in the early stages, is in the process of changing the practice of medicine.
These therapies will not only change healthcare, but will also lead to commercial success for the company and success in the market for investors.
One regenerative medicine company that’s currently off investors radar screens is Sernova Corp. (TSX-V: SVA, OTCQB: SEOVF, FSE: PSH).
However, with all Sernova has going on for it, the academic partnerships and R&D alliances, the company will begin to attract serious market attention, and possibly big pharma attention, in 2017.
Sernova Corp. is a clinical stage regenerative medicine company developing their Cell Pouch System™ for the treatment of chronic debilitating metabolic diseases such as diabetes, blood disorders including hemophilia and other diseases treated through replacement of proteins or hormones missing or in short supply within the body.
Sernova Corp. has developed the subcutaneous Cell Pouch™ and has specifically designed it to overcome the issues with previous implanted devices for cell transplantation.
Sernova’s implantable prevascularized macro-encapsulated Cell Pouch™ is a versatile and scalable, first-in-class medical device made entirely of FDA approved materials. The Cell Pouch System™ provides a natural “organ-like” environment rich in tissue matrix and micro-vessels. This is the ideal environment for therapeutic cells to thrive which then release proteins and/or hormones as required.
Sernova’s extensive preclinical safety and efficacy studies have shown this device to be both safe and effective, while being sparing of islets, supporting its design and function. The Cell Pouch™ being thin and typically smaller than a business card, fits easily under the skin with virtually no visibility.
Sernova Corp.’s Cell Pouch™, using human donor islet cells to produce insulin, should begin formal U.S. Food and Drug Administration (FDA) directed clinical testing in Type I/II diabetes early in 2017.
Phase I clinical human testing with porcine-derived islets and formal human studies using stem cell-derived islet cells will follow.
Sernova has entered into partnerships with the University of Toronto (a stem cell-derived diabetes technology licensing/alliance), Harvard University and the University of Chicago.
Sernova has also entered into R&D alliances with leading regenerative medicine and disease-specific organizations like the University of Toronto-affiliated Centre for Commercialization of Regenerative Medicine and the Juvenile Diabetes Research Foundation.
Sernova’s Cell Pouch™ potential is not limited to just islet cell transplantation in diabetes. Sernova has an R&D collaboration ongoing to develop cell therapies for treating hemophilia A (already funded from the European Commission’s Horizon 2020 program), and a separate alliance with the University of British Columbia focused on thyroid disorders.