Florida Is Now a Haven for Unproven Stem-Cell Treatments

Florida is the The last state to bypass the authority of Food and Drug Administration by allowing patients to access certain stem cell treatments which have not been rigorously evaluated and approved.

Under a new law which came into force on July 1, doctors in Florida can administer unprecedented therapies for STEM cells for wound care, pain management or orthopedics. The law is involved in the midst of increasing support for medical freedom in the United States, an idea adopted by the Secretary of Health and Social Services Robert F. Kennedy Jr., and he could encourage other states to follow. Supporters say that the law helps protect patients, while criticism argues that it opens the door to physical and financial damage.

“There is an interest in various states to allow the sale of STEM cell products that have not been approved by the FDA,” explains Leigh Turner, bioethicist and health, company and behavior professor at the University of California in Irvine, who followed the STEM cell industry. “I think we will see more.”

Last year, UTAH adopted a law allowing State health care providers to offer placental therapies on STEM cells, which are often marketed to treat injuries and injuries, as long as they clearly note their unprecedented status and obtain an informed consent of patients before administering them. And a 2017 law in Texas allows clinics and companies to offer therapies not approved by STEM cells to people with chronic or terminal diseases when conventional processing options have been exhausted.

Stem cells have been in immense interest for 30 years due to their ability to produce copies of themselves indefinitely and to form cells more specialized in the body. The stem cells are at the heart of human development during pregnancy and can be found in embryos, placental tissues and blood of the umbilical cord, and are also produced naturally by adults, especially in the bone marrow, to allow the body to repair. They have been studied as treatments for a wide variety of ailments over the years, including arthritis, diabetes, heart failure, multiple sclerosis and Parkinson’s disease.

But despite decades of research, stem cells have not produced the types of remedies that scientists had hoped. The only products approved by the FDA are the stem cells of blood training from the blood of the umbilical cord. They are used in transplants to treat patients with certain cancers and blood and autoimmune disorders that have undergone their own blood training stem cells destroyed by high doses of chemotherapy or radiotherapy.

Florida law prohibits STEM cell therapies derived from embryos and classifies the use of embryonic stem cells as a third degree crime. It also prohibits the use of cells withdrawn from umbilical cords after abortions, although it comes to come from cells from umbilical cords and placentas thrown after living births.

The FDA regulates therapies on stem cells like drugs unless they are “manipulated little”, which means that any treatment of cells does not significantly modify their original biological characteristics. This gap has enabled clinics and companies to bypass the drug approval process that has followed years and to offer stem cell treatments that have not been carefully tested for safety and efficiency. The law of Florida does not specify if the stem cells offered in the state must be manipulated little, probably allowing the cells which are manipulated beyond this standard.