Position Statement on Use of Allogeneic Cell Therapies in the State in Florida

August, 2025 – Florida law now allows licensed physicians in the state, including those at Karli Health Institute to offer donor-based stem cell treatments (also known as allogeneic therapies) that are not yet FDA-approved, when used for specific health needs: orthopedic problems, pain management, or wound care.

We’ve long offered regenerative treatments using your own cells (autologous therapies), backed by years of clinical practice and research. Now, under Florida’s new law, you also have the option to consider donor-based therapies, if they meet safeguards defined by the law.

The safety and effectiveness of these treatments remain uncertain. Because they haven’t undergone FDA-approved clinical trials, we cannot fully know the risks or how likely they are to help.

To ensure your safety and uphold ethical standards, the law requires that:

• Stem cells come from ethically sourced materials, such as adult tissue, placental tissue, or umbilical cords after a live birth, but not from embryos or aborted fetal tissue.
  
• The facilities that handle these cells must be FDA-registered, accredited by recognized organizations (like the National Marrow Donor Program or the AABB), follow Good Manufacturing Practices (cGMP), and provide a post-thaw cell count and viability report confirming live cells. 
• Only licensed physicians acting within their professional duties can offer these treatments
• Before any treatment, you’ll receive a written, clearly legible notice stating:

“This physician performs one or more stem cell therapies that have not yet been approved by the United States Food and Drug Administration. You are encouraged to consult with your primary care provider before undergoing any stem cell therapy.”

• And you’ll be asked to sign an informed consent form written in everyday language, covering:
  • What the treatment involves
  • That the treatment is not FDA-approved
  • Expected results and what we don’t yet fully understand
  • Risks, potential benefits, and alternatives (including doing nothing)
  • A recommendation to discuss it with your primary care provider.

Our Commitment to You and the State of Florida at Karli Health Institute

At Karli Health Institute, we believe in transparency, patient choice, and safety. Here’s how we honor that commitment:

• Safe sourcing: We’ll only work with suppliers that meet FDA registration, accreditation, and cGMP standards, and provide verified, viable cells.
• Transparent information: You’ll see the required notice, and we’ll walk you through the consent form – addressing any questions that you might have.
• Respect for your choice: We respect your preference to use autologous therapies, allogeneic treatments, both, or neither in your care and we’ll discuss all options with you.
• Ongoing monitoring: If you choose allogeneic treatment, we’ll use accurate implantation techniques and track safety and treatment outcomes over time using our dedicated data platform.