MIAMI—In early March, Wyoming became the fourth state with “Right to Try” laws on the books, permitting stems cells for pain therapy, without the benefit of FDA approval. Florida legislation was signed by Gov. Ron DeSantis on July 1, 2025, specifically for orthopedics, wound care, and pain management. An estimated 5 million Floridians—roughly 20% of the state’s population—have arthritis or chronic pain issues.
Utah also permits the use of non–FDA-approved stem cells, as does Nevada, with an earlier version of Right to Try passed in 2024 and 2023, respectively, for individual stem cell procedures.
The federal Right to Try Act, which was enacted in 2018, allows patients with life-threatening illnesses who have exhausted approved treatment options to access certain investigational drugs, biologics, or devices that have passed phase 1 testing but are not yet FDA approved. It bypasses FDA oversight to allow direct coordination between patients, doctors, and manufacturers, according to the agency.
While there is federal authorization, there is no uniformity to the law when it comes to administration; pain medicine practitioners must look to state guidance. Some practitioners anticipate a potential wave of medical tourism to their states for those seeking a regenerative medicine option.
At the Biotechnology Industry Organization conference, held the first week of March, the news of new Right to Try open markets created a groundswell of interest for labs to create them in purified cleanroom environments.
“We can create and produce stems cells for up to 10,000 patients a year here in Florida and offer them nationally in Right to Try states,” said Jesse McCool, the president of GBI Biomanufacturing, in Plantation, Florida. “If our team can begin to use 3D production techniques, we can scale up to 1 million patients a year here.” He believes the demand is coming quickly with DeSantis’ new law, authored by State Rep. James Buchanan.
“U.S. manufacturing in labs is critical now,” McCool said. The stem cells are harvested from umbilical cord blood or bone marrow, he added.
Bruce Werber, MD, is a surgeon dedicated to limb preservation and a practicing physician at InMotion Foot and Ankle, in Boynton Beach, Florida. He also serves at the Institute of Regenerative and Cellular Medicine, in California.
“Yes, I do expect an uptick in medical tourism to Florida; however, it’s been a little slower to catch on since July of last year,” Werber said. “We expect an over 85% success rate with previously nonresponsive patients. These stem cells and exosomes have a strong safety record with no negative side effects. The medicines can work for meniscus and other typical injuries because stem cells work within the vascular system.
“Because stem cells reduce inflammation, they are also indicated for treating arthritis,” Werber said. “This support is based on the quality of the synovial fluid which is more viscous and will lubricate the joints.” Synovial fluid is a viscous, egg-white–like, clear, or pale yellow substance located within the cavities of synovial joints (knees, hips, and shoulders). Its primary function is to act as a lubricant, reducing friction between articular cartilage.
Werber specializes in the translational science of placental-derived biologics, including mesenchymal stem cells, exosomes, and neuromodulatory therapies. As the CEO of BioXtek and an adjunct professor of surgery, he continues to advance regenerative medicine through research, product development, and physician education.
He offered advice for pain medicine doctors who may wish to engage in stem cell therapy for pain patients.
“I would recommend the ease of use of these biologic products, the lower learning curve of administration and monitoring, and that we don’t run the risk of really hurting anything,” Werber said.
He cautioned that treatment of wounds and reimbursement from Medicare patients can be challenging, but said, “Let’s use this therapy on our patients and give them the options they need today; after all, these patients really do have a right to try.”
—Michael Smith
Link to published news story: https://www.painmedicinenews.com/Policy-and-Legislation/Article/04-26/-Right-to-Try-Laws-Place-Stem-Cells-Front-and-Center-in-Regenerative-Pain-Medicine/80207
