For individuals exploring stem cell therapy, a common and often confusing question arises:
“If stem cells are so promising, why aren’t they regulated in the United States the way other medical treatments are?”
It’s a valid concern—and one that deserves a clear, compassionate, and science-backed explanation.
Understanding the Regulatory Gap
In the U.S., most medical therapies—including biologics—are overseen by the Food and Drug Administration (FDA). Yet stem cell therapy occupies a uniquely complex regulatory space. Often falling under the designation of “minimally manipulated,” some stem cell procedures may be administered without full FDA approval—so long as they meet specific criteria.
However, the boundary between what qualifies as minimally manipulated and what exceeds that threshold is ambiguous, resulting in inconsistent regulation across the country.
The Role of the FDA
Regulatory agencies such as the FDA take a careful, evidence-based approach to stem cell therapies, ensuring that each approved product meets the highest safety and efficacy standards. While only a few stem cell–based products are currently approved in the U.S., mostly for blood and orthopedic issues,
Ongoing research worldwide continues to expand our understanding of how these cells can support healing. Many other applications of stem cell therapy, such as neurological or degenerative conditions, remain investigational in the U.S. This means it’s still under study rather than formally approved.
At Stem Cell Institute, we share this commitment to advancing science responsibly, always prioritizing patient safety and ethical care.
What’s Changing: Florida’s July 1, 2025 Law on Stem Cell Use
Effective July 1, 2025, Florida enacted SB 1768 and HB 1617, a law expanding access to FDA-unapproved stem cell therapies by licensed physicians—but only within strict boundaries, and only for certain conditions:
- Orthopedic care, wound healing, and pain management
- Stem cells must be sourced from FDA-registered, accredited tissue banks in Florida
- Must comply with cGMP (current Good Manufacturing Practices)
- Require informed consent, clearly informing the patient the therapy is not FDA-approved
- Explicitly bans use of embryonic or fetal tissue, with violations carrying felony penalties and professional disciplinary action
While this new framework broadens controlled access, it also reinforces the importance of responsible medical practice, underscoring the need for continued research, oversight, and patient education to ensure that advances in regenerative medicine remain both ethical and evidence-based.
Clinical Trials: Our Commitment to Science-Backed Practice
At Stem Cell Institute, we approach stem cell therapy with integrity, transparency, and a research-first mindset. We have:
- Published 70+ scientific articles and clinical trials, reinforcing our commitment to transparency and scientific validation
- Conducted 80,000+procedures since our inception
- Engaged in ongoing collaborations with leading domestic and international researchers and institutions to ensure our protocols reflect the latest in clinical research
- Led early work evaluating umbilical cord tissue–derived MSCs for multiple sclerosis, as documented in a clinical feasibility study in the Journal of Translational Medicine (2018)
By grounding our care in published research and clinical data, we provide patients with treatments that uphold scientific rigor—rather than speculative claims.
How Can I Get Stem Cell Therapy?
Navigating stem cell therapy options can feel confusing, especially when every country seems to have different rules and levels of oversight. This fragmented regulatory environment often leaves patients unsure where to begin.
At the Stem Cell Institute in Panama, our approach is designed to remove that uncertainty. We operate under rigorous ethical and scientific guidelines, combining advanced clinical protocols with an active research program led by our founder, Dr. Neil Riordan. Every treatment is guided by the same principles that have made our institute an international reference point in adult stem cell research and patient care.
“We understand how overwhelming it can be to search for non-traditional treatment. That’s why we’re here to help you find a treatment option that fits your unique needs. Patients have shared how much they value the long-standing research and carefully established protocols behind our therapies.” — Stem Cell Institute Patient Care Team
What We Believe
At Stem Cell Institute, we are not proponents of overstated claims or miracle cures. Instead, we:
- Center our offerings on thoroughly studied, adult stem cell therapies
- Rely on over two decades of experience, extensive peer-reviewed publications, and real-world clinical outcomes
- Encourage every patient to ask questions, seek counsel from their physician, and review published research
Stem cell therapy isn’t a guaranteed solution, nor is it the right choice for everyone. However, for many patients, it represents an important step forward — a chance to explore new possibilities for healing and a better quality of life.
Final Thoughts
Stem cell therapy exists at the intersection of innovation, patient need, and evolving regulation. At the Stem Cell Institute, our mission is unwavering: to provide compassionate, ethically grounded, and research-driven care for those seeking new possibilities when traditional options have fallen short.
Stem Cell Institute in Panama City, Panama, is at the forefront of applied stem cell research. Since our inception in 2008, we have performed over 80,000 procedures, helping thousands of families across the United States and around the world embrace the opportunity for a better life. Our medical team prioritizes the health and well-being of all our patients through top-notch stem cell treatment and care.
