Florida has made remarkable strides in increasing access to regenerative medicine, especially in the realm of stem cell therapy, with the enactment of House Bill 1617, effective July 1, 2025. This legislation opens up new avenues for patients looking for relief from chronic pain, wounds, and orthopedic conditions, while also incorporating vital safeguards to uphold public health and ethical standards.
According to this law, licensed medical professionals in Florida—including MDs, DOs, and PAs regulated by Chapters 458 and 459 are now permitted to administer specific stem cell therapies that have not yet received FDA clearance. Nevertheless, there are stringent restrictions:
Treatments must be strictly related to orthopedic issues, wound care, or pain management.
Procedures must stay within the healthcare provider’s area of expertise.
This legislation does not authorize the unregulated application of stem cells for experimental, cosmetic, or unrelated medical purposes.
A crucial component of the law includes the prohibition of certain types of stem cells to ensure ethical standards and patient safety. The following are specifically not allowed:
Fetal-derived stem cells
Embryonic tissue acquired from abortions
Adipose-derived mesenchymal stem cells (obtained from body fat)
Instead, treatments must utilize stem cells from ethically sourced, clinically appropriate alternatives that align with the law's stringent requirements.
To safeguard patients from possible risks, the law enforces strict standards for facilities and manufacturing:
All stem cells must be obtained from FDA-registered establishments
Processing has to take place in clean rooms that feature high-efficiency air filtration systems.
Facilities must receive accreditation from respected organizations, such as the National Marrow Donor Program or the American Association of Tissue Banks.
These precautions guarantee that patients receive therapies produced in controlled environments designed to reduce contamination and uphold clinical integrity
Your Rights
Prior to undergoing treatment, each patient must receive clear information indicating that the stem cell therapy is not FDA-approved. Providers are required to:
Deliver a written notification specifying this information.
Display the notification prominently in their practice and in all forms of advertising.
Ensure that the notification is presented in a font size that is not smaller than the largest font used in any advertisement.
Moreover, patients must sign a comprehensive consent form that covers:
The nature of the treatment and its status regarding United States Food and Drug Administration approval.
The anticipated outcomes of the therapy.
Possible risks and complications.
Available alternative treatments, including the option to forgo treatment.
This protocol protects your right to make informed healthcare decisions. Take your time to ask questions and fully grasp the information before moving forward.
Stem cell therapies provide genuine hope for managing pain, regenerating tissue, and recovering from orthopedic issues. However, progress in medicine should be paired with accountability and transparency. Florida's new legislation reflects a careful balance between access and safety.
If you're contemplating stem cell therapy, keep these three important steps in mind:
Verify the credentials of your provider and their adherence to House Bill 1617.
Understand the origins of the stem cells and ensure they are legally acceptable.
Thoroughly review all documentation and consult with your primary care physician before making any decisions.
Florida's new stem cell legislation signals thrilling advancements in regenerative medicine, but it also necessitates shared responsibility between healthcare providers and patients. It's not merely a shortcut; it’s a regulated opportunity for science-based treatments within specific medical contexts.
At Glory Regenerative Center, we are dedicated to assisting you in navigating these changes with clarity, assurance, and care.
To discover more about whether stem cell therapy is suitable for your condition or how this legislation pertains to your care, please reach out us for guidance and support.
