The second section of Tony Robbins’ latest book, Life Force (coauthored by Peter Diamandis, MD and Robert Hariri, MD, PhD) takes us through the state of the art of regenerative medicine. Presently, patients needing organ transplant have to wait for someone to die before a donated organ can be harvested. Unfortunately, donated organs are frequently not in good enough shape after the death of the donor. Even if they are acceptable, then there’s the risk of organ rejection so a lifetime of immunosuppressant drugs follows.
There are hundreds of thousands of scientists dedicated to changing this rather primitive story and improve patients’ circumstances and outcomes. Robbins highlights a few top people leading the way.
Fueled by a passion to save her own daughter’s life Martine Rothblatt founded the biotech firm United Technologies and is a major player in pioneering organ regeneration. Environmentally conscious and cognizant of the carbon footprint these efforts could leave, in 2018, she had UT’s 140,000 square foot headquarters rebuilt as the largest zero-carbon-footprint building in the world. She also had the vision to back the design and manufacture of all battery-powered helicopter drones to deliver organs without the use of fuel or noise pollution.
Harvard geneticist George Church, PhD, founder of eGenesis is working to make transplant organs more readily available through xenotransplantation (transplanting modified pig organs to humans). eGenesis cofounder Luhan Yang figured out how to edit out viruses in the pig genome. The virus-free pig organs have been successfully transplanted into primates at Massachusetts General.
At the Salk Institute of California scientists working under Juan Carlos Izpisua Belmont are meanwhile cultivating human organs inside pigs via human stem cells. Mass General’s Chief of Transplant Surgery, Dr. James Markmann said, “Everybody sees we’re at a turning point.”
Routine pig-to-human transplants could truly transform healthcare beyond simply increasing supply. Organs would go from a product of chance … to the product of a standardized manufacturing process… Organ transplants would no longer have to be emergency surgeries, requiring planes to deliver organs and surgical teams to scramble at any hour. Organs from pigs can be harvested on a schedule and surgeries planned for exact times. A patient admitted with kidney failure could get a kidney the next day, eliminating the need for large dialysis centers. Hospital ICU beds will no longer be taken up by patients waiting for a heart transplant.Sarah Zhang, The Atlantic
Eric Lagasse, PhD, from the University of Pittsburgh, founded the startup LyGenesis to repurpose a patient’s lymph nodes. Over the last decade he has discovered that these cellular factories of infection fighting T cells can be repurposed as bioreactors. By injecting or engrafting a lymph node with liver cells, the cells will grow and multiply into mini livers to assist in filtering out toxins for partially functioning livers. LyGenesis is in Phase 2 clinical trial with these mini-livers in patients with end-stage liver disease. LyGenesis plans to utilize the same process to create mini-pancreases.
Inventor and engineer Dean Kamen was given an $80 million grant by the Obama Administration to put all the existing regenerative science together and create an industry to manufacture replacement human organs at scale. Kamen named the company Advanced Regenerative Manufacturing Institute (ARMI) which today has 170 member organizations contributing to this end game. Right before COVID-19 hit the U.S., Kamen and his engineers had their first prototype machine.
In a demonstration of how far they’ve come, Kamen said they dropped a frozen vial of pluripotent stem cells (iPSCs) in one end of the completely sealed machine. Three weeks later a three-inch-segment of freshly grown bone and ligament came out the other end. It was of high enough quality to be used in the repair of an ankle. The next goal is to produce fully functional pediatric hearts in 40 days. They plan to have pediatric hearts available for clinical trial by 2024. Kamen believes within this decade ARMI will be able to manufacture replacement human organs from scratch. Wow!
Immunotherapy (boosting our immune system with living cellular medicines) is a welcome alternative to chemotherapy and other cancer fighting interventions but chemo is still the last line of defense in solid cancers. This too will likely be changing, thanks in part to the work of Dr. Carl H. June and his colleagues at the University of Pennsylvania. In 2010 they treated a terminal leukemia patient with CAR T cells, (Chimeric Antigen Receptor T cells) an infusion of the patient’s own T-cells that had been genetically modified with neutered HIV virus.
Almost nobody thought it would work but at the 11th hour, this patient rallied from treatment and the intense cytokine storm that followed it and emerged cancer free. CAR T therapy has since been approved by the FDA for acute lymphoblastic leukemia in children and most recently to treat non-Hodgkin’s lymphoma. In 2019 Medicare unveiled a coverage plan for these very costly CAR T cell therapies.
While not everyone survives or escapes the sometimes damaging after effects of CAR T therapy, it is saving lives and improving the quality of life for hundreds of thousands. The outlook is promising for CAR T cell therapies to improve and perhaps one day replace chemotherapy as the standard of care for solid tumors. June calls it immuno-oncology. There are currently more than 600 clinical trials using CAR T cells.
Incisionless brain surgery is also disrupting the regenerative healthcare space with the use of Focused Ultrasound. After 20 years of research and development the FDA approved focused ultrasound for the treatment of Essential Tremor in 2016 and Tremor Dominant Parkinson’s in 2019. The Israeli medical device company Insightec’s technology has relieved tremors and joint stiffness in 80% of these patients without surgery or general anesthesia. Precision Ultrasound doesn’t cure the underlying conditions, the speech problems or cognitive decline but it does improve critical movement allowing patients to live a better quality of life.
Focused Ultrasound is also treating brain cancers. By lowering the power and injecting micro bubbles into the bloodstream, the molecular commotion pulls cells apart and temporarily opens the blood brain barrier so chemotherapy drugs can get through. With the FDA’s approval to open the blood brain barrier completely, Insightec scientists believe they can make significant strides in not only brain cancer but Parkinson’s and Alzheimer’s as well. There is evidence that opening the blood brain barrier allows the immune system to get into the brain, detect the plaque build-up and destroy it.
One of the final chapters in this section is about Gene Therapy and CRISPR (gene editing) to cure disease. Ever since The Human Genome Project was completed in 2003, gene sequencing has been not only possible but faster and cheaper. With these individualized genomic maps, precise cellular intervention has become possible. Gene therapy replaces defective or missing DNA inside a cell while CRISPR repairs DNA inside the cell. Stem cell therapies replace the cell entirely. There are 2,500 gene therapy clinical trials that have either been approved, are in progress or have already been completed.
There are many stories interlaced within these chapters to illustrate the power, progress and setbacks of these new therapies. The most promising one documents a cure for hereditary blindness with a single stem cell injection to the back of the eye. In another, gene therapy is being used to repair heart damage by reprogramming fibroblast cells (cells in the heart that produce scar tissue when the heart is over-stressed) in mice to produce new heart muscle. Tenaya Therapeutics, which went public in late 2021, is working to reprogram fibroblasts in human patients to restore cardiac function post heart attack.
In the final chapter of section 2, Robbins introduces us to Turkish genius Osman Kibar, founder of the startup Biosplice. In a nutshell, Osman has figured out how to reset the signals to our body’s own stem cells via something called the Wnt Pathway. As we age, the Wnt pathway loses connection with the progenitor stem cells left behind after we’re born, the cells meant to regenerate damaged tissue. Using proprietary small molecules, Biosplice has gathered a decade of evidence that they can potentially restore the health of any tissue with a single injection.
After securing 8 patents in virtual stealth mode, they are in Stage 3 Clinical Trial for Lorecivivint a molecular therapy that restores degenerative disease in rats and may prove to be an effective treatment for osteoarthritis by stopping the degradation of cartilage and regrowing lost cartilage. In November 2021, Biosplice entered its molecular cancer therapy drug Cirtuvivint into a Phase 1 Trial for advanced stage (castration resistant) prostate cancer, non small cell lung cancer and colorectal cancer.
I’ve been reading and writing since yesterday and am stopping now. I’ll provide more coverage on Life Force in a day or so. We are living in an incredible time! Heartfelt thanks to all the scientists, researchers and dedicated doctors who labor every day to make the world a better place. Heroes one and all. ❤️