Peter Schorsch
Last month, Gov. Ron DeSantis signed several bills into law, including SB 1768, which pertains to “Stem Cell Therapy.”
His approval of stem cell therapy establishes the state’s first framework for regulating and expanding access to what is known as “regenerative medicine.”
The measure, which took effect on July 1, was sponsored by Sen. Jay Trumbull and Rep. James Buchanan, who view the treatment as a significant step forward for patients seeking safe alternatives for chronic pain, orthopedic injuries, and wound care with minimal downtime.
“Opening a market in Florida for stem cell therapy paves the way for Florida to lead in innovative, ethical, and effective treatments for complex challenges,” Buchanan said.
Stem cell therapy uses healthy cells to repair or replace damaged tissue, accelerate healing, and reinvigorate the immune system. The treatment has already been approved by the U.S. Food and Drug Administration (FDA) for conditions such as leukemia, lymphoma, and certain neurological disorders. SB 1768 expands access to the therapy beyond these existing uses, creating a safety and regulatory framework that increases availability while ensuring strict quality control.
The new law bans the use of fetal or embryonic stem cells, as well as umbilical-derived cells from abortions. Instead, it permits the use of ethically harvested stem cells from discarded umbilical cords and placentas after live births — materials typically classified as medical waste.
“Stem cells, when used safely and sourced ethically, have the potential to transform health care by increasing access to less invasive treatments, accelerating recovery times, and improving patient outcomes,” according to Sen. Trumbull.
Proponents of the legislation argue that regenerative medicine could reduce the need for surgeries, shorten recovery periods, and decrease long-term dependency on opioids and other pain medications.
“Stem cell therapy for orthopedics, wound care, and pain management is less invasive than surgery, accelerates healing, and improves patient outcomes,” said Dr. Felix Lurye, chief medical officer at Americell, a leading supplier of ethically sourced stem cell products in Florida.
SB 1768 also sets a high standard for safety and quality. Stem cell products used in Florida must be retrieved, manufactured, and stored in American laboratories that are certified by one of several recognized accrediting organizations, including the NMDP (formerly the National Marrow Donor Program), World Marrow Donor Association, Association for the Advancement of Blood and Biotherapies, or the American Association of Tissue Banks. Labs must provide documentation verifying cell viability and source transparency.
Advocates say the benefits will extend beyond immediate relief for patients. By expanding access to regenerative treatments, fewer intensive surgeries could reduce health care costs and lessen the strain on hospitals and providers.
The treatment also promises economic benefits for Florida, a leader in health care innovation. Supporters believe the new law will help solidify Florida’s reputation as a national leader in biotech and biomedical innovation, attracting companies and researchers while boosting the state’s growing medical tourism industry.
Biotourism is a booming global industry valued at over $1 billion annually, with a significant portion of the market concentrated outside of the United States. Without access to stem cell therapy in the United States, patients are often forced to travel abroad for advanced treatments.
“With this legislation, we’re opening new markets for Americans to benefit while implementing proper regulations to ensure safety, quality, and transparency,” Trumbull said.
Americell, which distributes stem cell products exclusively for physician use in Florida, praised the bill for codifying ethical and safety standards into law.
The company only distributes products derived from cord blood collected after live births in the United States, and its supply chain adheres to both state and federal regulations to ensure quality and transparency.
With SB 1768 now in effect, Florida is poised to become a leader in ethical and effective stem cell therapy, transforming lives while advancing innovation in health care.
