On June 12, 2017, Texas Governor Greg Abbott signed House Bill 810, known as “Charlie’s Law,” which gives patients never-before-seen access to non-FDA approved autologous and allogenic cellular-based therapies. Texas is the first state in the United States to pass such a law, and it will allow patients with certain chronic diseases or terminal illnesses the ability to seek out stem cell treatments within the state of Texas.
This legislation is a step in the right direction for the advancement of Regenerative Medicine and cellular-based therapies; however, this bill is not a catch-all for stem cell treatments. There is still plenty of ground to be made by lawmakers when it comes to Regenerative Medicine legislation, and in this post, we explain the details of the law and spell it out for the general public.
- House Bill 810 gives patient more treatment options close to home
House bill 810 makes it legal, under certain circumstances, for a physician to provide a non-FDA approved therapy to a patient in the State of Texas, and it creates more options for Americans in extreme medical conditions, like multiple sclerosis, to seek alternative treatments.
Currently, patients commonly travel to other countries like Europe, Central America, and the Caribbean to receive expanded stem cell treatments and IV stem cell treatments because cellular-based therapies are less regulated in those locations. This legislation now allows patients the freedom to seek out these treatments in the State of Texas and find a physician, who is compliant with all laws and regulations, while staying in the U.S. and saving thousands on travel expenses.
- House Bill 810 has many caveats and restrictive requirements
The bill states that once a patient receives a diagnosis of having a “severe chronic disease or terminal illness,” they can explore the option of undergoing an “investigational stem cell treatment.” It is important to point out that this mode of therapy:
- is under investigation in a clinical trial and being administered to human participants in that trial; and
- has not yet been approved for general use by the United States Food and Drug Administration (FDA).
Translation: For a physician to utilize non-FDA approved cellular-based therapies, it requires Institutional Review Board (IRB) approval. An IRB is a type of committee that reviews and monitors research and testing on human subjects. This venture requires a lot of time and money to achieve, so challenges may arise for physicians who want to provide non-FDA approved therapies but cannot afford IRB approval.
Second, these non-FDA approved procedures cannot take place in a clinic setting or physician office. Legislation requires that they be conducted at a hospital, medical school, or Ambulatory Surgery Center (ASC). Along with the procedural costs can come facility costs which can place a financial burden on some patients.
- House Bill 810 opens the door for big pharmaceutical companies to compete in the Regenerative Medicine space
The long-term effects of this bill remain to be seen. However, one can speculate that the future looks brighter for companies seeking to create “stem cells in a bottle” that can be sold off a shelf. The benefits of such a product are 1) they are much more affordable; 2) they can be mass-produced; and 3) they are convenient.
Allogenic products, such as amniotic tissue products, do not come from one’s own body but rather are from allograft sources (donor-derived). These large companies would be given the opportunity to seek out IRB approval for their products, fund large-scale studies in hospitals, and then sell their products to physicians in hospitals. This could pose a challenge for patients seeking autologous treatment (self-derived) which has been shown in the literature to have superior outcomes (for decades), and does not pose the risk of immune rejection since it is derived from the patient’s own cells.
- This is a major step for the Regenerative Medicine community
Never before has there been such robust legislation regarding Regenerative Medicine. This law will give patients the opportunity to seek non-surgical and alternative methods for treating diseases and illnesses that have failed conventional treatments. With an aging global population and the rising dangers of opioid addictions, regenerative medicine continues to find its place in healthcare. Entrenched, outdated, and invasive medical procedures compete increasingly more often with innovative, emerging, and minimally invasive techniques – technologies capable of not only treating a patient’s symptoms, but also resolving the underlying problem.
All in all, the signing of House Bill 810 into law is a major step in the right direction for Regenerative Medicine, but there is still a long way to go. This bill both achieves progress and makes things more unclear. For instance, what will this do to the cost of current Regenerative Medicine procedures, like bone marrow-derived stem cell therapy, platelet-rich plasma, and Prolotherapy? What effect will this have on insurance coverage (or lack thereof)? Only time will tell the long-term effects of Charlie’s Law. The emergence of Regenerative Medicine, however, is not a matter of if, but when.