A question we get asked all the time is, Why would regenerative, adult stem cell therapy not be allowed in the U.S.? In our opinion, the answer boils down to two factors. First, adult stem cells will compete with highly profitable, multi-billion- dollar pharmaceutical interests. Second, the patent landscape around adult stem cells is cloudy, and no one is particularly interested in spending in excess of $1 billion to get a cell drug approved with no patent protection. In our opinion, academia and industry with vested interests in ethically controversial embryonic cells actively attack and discount the efficacy of adult stem cells due to their conflicts of interestfearing the loss of research grants and patent royalties.
I have personally experienced the power of my own adult stem cells and am six years post-therapy for disabling rheumatoid arthritis. -Dr. Stanley Jones
Why do adult stem cells make economic sense? The average care for a chronically ill patient can cost well in excess of $100,000 annually. Many conditions can be treated with stem cells for $20,000 a year, and in some cases, the results can last for years. For orthopedic conditions, like osteoarthritis of the knee, a simple stem cell shot costing under $5,000 can regrow cartilage and prevent, or postpone, the need for knee replacement surgery or knee orthoscopic knee surgery, which can cost up to $50,000 and $30,000, respectively.
Once cellular therapy becomes part of mainstream medicine, these cost savings will help salvage the Medicare budget. Congress is now becoming aware of the benefits in saving and improving lives, with potentially enormous cost savings. In 2016, Senator Mark Kirk (R-Ill.) introduced legislation to make cellular therapy a reality. A reality that will save billions of dollars in the approval process for a stem cell treatment to make it to market and cut the time in half.
A number of our physicians also support adult stem cell therapy being made available to all who need it in the U.S. One of those physicians is Dr. Stanley Jones, Chief Medical Officer of Celltex Therapeutics in Houston, Texas. Dr. Jones, a stem cell patient himself says:
I have personally experienced the power of my own adult stem cells and am six years post-therapy for disabling rheumatoid arthritis. I am no longer taking medication and I feel great. I am proud to report that Celltex continues to improve quality of life for our clients, and we are more encouraged now than ever to fight for legislation that provides a new regulatory pathway for autologous stem cell therapies in the United States. We have seen great results in our clients, and we know other stem cell companies whose clients are seeing the same amazing results with no observed side effects. What a tragedy that we have to travel outside of our great nation! We need to keep the momentum moving forward so one day Americans can have the right to access our own stem cells in our own country.
The Wichita Eagle Beacon ran a story about Ryan Benton, a Duchene’s Muscular Dystrophy patient. Ryan received umbilical cord tissue-derived mesenchymal stem cell treatment, also considered adult stem cells, following the FDA’s approval of his doctors application for a single patient, investigational new drug for compassionate use. The stem cell technology utilized in Ryans treatment was developed by renowned stem cell scientist Neil H. Riordan, Ph.D. Dr. Riordan is the founder and president of the Stem Cell Institute in Panama City, Panama and Medistem Panama, which provides cell harvesting and banking services for their US-based cGMP laboratory partner. Ryan recently celebrated his 30th birthday, and he says he feels the stem cell treatments have dramatically slowed down the progression of his disease since his first treatment at 22-years-old.
Congress Takes Action On Cellular Therapy
In March 2016, the Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act was introduced to the senate by Sen. Mark Kirk (R-Ill.) Sen. Kirk knows first-hand what it means to be disabled after suffering a stroke in 2012. He also knows that cellular therapy is the only treatment that can repair stroke damage.
We must continue to promote regenerative and personalized medicine, which is why I worked so hard along with my colleagues on the Energy and Commerce Committee to pass the 21st Century Cures Act.– Congressman Joe Barton
This is a shining example of bi-partisan, bi-cameral legislation. Sen. Kirk is joined by the fellow Senators Joe Manchin (D-WV) and Susan Collins (R-ME) as well as House Representatives Mike Coffman (R-CO), Mark Takai (D-HI) and Morgan Griffith (R-VA) as co-sponsors.
Cellular therapies are proving to be safer and more effective than drugs for many conditions, but they should not have to face the same drug approval pathway, typically lasting 10 years and costing more than $1 billion on average. This legislation would cut this time and cost in half. Once phase-2 trials are complete showing safety and signs of efficacy, a five year conditional approval period allowing broader patient access would commence, culminating in approval and insurance coverage if safety and efficacy goals are met.
How Patients Can Support Stem Cell Legislation
Patients are constituents, and we can all make sure our congressional representatives also support the REGROW Act. San Antonian Stefanie Cowley, a multiple sclerosis patient, adult stem cell recipient and a dedicated patient advocate, is making her voice heard by speaking with news media and her representatives. Within days after receiving stem cell therapy, Stefanies pain level due to multiple sclerosis was greatly reduced.
Two of the founding members of PFSC, Tracy Thompson and Jennifer Ziegler, met with Congressman Joe Barton (R-TX) to talk about the possibilities of adult stem cell legislation. Sen. Barton commented:
It is always great to hear more about medical breakthroughs. We must continue to promote regenerative and personalized medicine, which is why I worked so hard along with my colleagues on the Energy and Commerce Committee to pass the 21st Century Cures Act. Thank you to Tracy and Jennifer for taking the time to come meet with me in my Arlington, Texas office.
Since our start in 2012, Patients For Stem Cells has been fighting for the right to use our own stem cells for life-saving therapies. We are delighted that congress has taken up the cause and drafted legislation that will speed up access to adult stem cell treatments in the U.S. The last major disease to be cured was polio in the late 1950s. Many medical experts agree that adult stem cells will lead to cures for most diseases.
Patients For Stem Cells supports REGROW legislation. Our members and our doctors feel we are at the dawn of a new era in medicine. This is a unique opportunity to have your patient, caretaker or physician voice be heard. Adult stem cells will change the future of medicine.
For more information visit www.patientsforstemcells.org. You can also find Patients For Stem Cells on Facebook and Twitter.
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