(House Bill 1617 & Senate Bill 1768, Effective July 1, 2025)
Regenerative medicine has opened new doors in orthopedics giving patients non-surgical options for conditions like joint pain, arthritis, and tendon injuries. As this field grows, so do questions about quality, safety, and who patients can trust for these procedures.
On June 25, 2025, Florida passed a new law, Senate Bill 1768, that will have real consequences for patients exploring stem cell therapies. The bill allows physicians to offer certain non-FDA-approved stem cell treatments, even if they don’t specialize in musculoskeletal conditions or image-guided procedures.
That shift raises a critical question: How do you know if a stem cell procedure is being done the right way?
What’s in the Bill and What’s Not
The law focuses on access and removes some barriers so more providers can offer stem cell injections. But access without oversight can come at a cost. Now, procedures may be performed in clinics that lack image-guided tools, rigorous lab processing, or a history of tracking patient outcomes.
It’s not uncommon to see stem cell advertisements with flashy claims and vague details. What’s often missing are the questions that matter most:
- Is this procedure recommendation appropriate for my condition?
- How are the cells processed and are they viable?
- How precisely will the injection be delivered?
Knowing what to ask can be just as important as the procedure itself.
How to Tell a High-Quality Procedure from a Sales Pitch
1. Proper Candidate Selection
Consider a patient with moderate knee arthritis who’s tried physical therapy and wants to avoid surgery. Some clinics may offer stem cell injections to anyone who walks in the door regardless of imaging or severity. But a careful approach looks at MRI findings, functional goals, and tissue responsiveness before moving forward.
Why? Because regenerative offerings aren’t one-size-fits-all. For some, PRP might be enough. For others, bone marrow concentrate may be more appropriate. And for a few, surgery is still the best option.
The best clinics don’t just perform injections, they help patients avoid ones that won’t help.
2. Biologic Processing That Actually Works
There’s a difference between a biologic being injected and a biologic actually working. Research shows that dose and cell concentration matter. But many commercial kits offer convenience over quality, often delivering cell counts too low to meet therapeutic thresholds.
In contrast, lab protocols that adjust centrifuge speeds, separate cell layers precisely, and assess platelet or stem cell concentration provide a far more tailored and effective procedure.
A patient with a chronic rotator cuff tear, for instance, might need a high-concentration marrow aspirate targeted into the tear. That’s not something an off-the-shelf device can deliver.
3. Imaging Guidance Isn’t Optional
Imagine placing cells into a narrow hip joint capsule or around a torn ligament in the thumb. Doing this by feel or with vague anatomical landmarks is like trying to park a car blindfolded. Even a few millimeters off, and the injectate could miss the damaged tissue entirely.
High-resolution ultrasound and fluoroscopy aren’t just fancy tools, they’re essential for accuracy. The most successful outcomes tend to follow precise delivery into the affected structures, not general areas.
If a clinic doesn’t routinely use image guidance, the patient has no way of knowing if the cells are reaching the right target.
Red Flags in the New Landscape
With the passage of SB 1768, expect to see a wave of “stem cell” offerings, many using birth tissue products like umbilical cord or amniotic fluid. While these products are marketed as containing live stem cells, extensive independent testing has never found live stem cells in any commercial birth tissue product.
One clause in the new bill requires manufacturers to report “cell counts,” but that’s not the same as “stem cell counts.” It’s a loophole that allows companies to claim potency without proof. Patients may believe they’re getting stem cell therapy when in fact they’re not.
To date, no umbilical or amniotic product has completed a 3-phase FDA trial, and none are approved for orthopedic injection.
Questions Worth Asking
Before considering any regenerative procedure, patients should ask:
- What type of cells are being used and are they autologous (from my own body)?
- How are the cells being processed? Is a custom protocol used, or a kit?
- Is the injection guided with ultrasound or fluoroscopy every time?
- What data do you have on outcomes for patients like me?
- Do you report those outcomes to a registry or track long-term results?
These questions aren’t just for peace of mind, they directly impact results.
The Bottom Line
Florida’s new law may expand who can offer stem cell procedures, but not all providers are prepared to deliver them with the precision, science, and ethics patients deserve.
Stem cell therapy is not a product; it’s a procedure that depends on accurate diagnosis, customized cell processing, and image-guided delivery. When done well, it has the power to delay or prevent surgery, restore function, and reduce pain. When done poorly, it becomes an expensive placebo or worse.
Knowing the difference isn’t just smart, it’s essential. We’re here to help you make confident, informed decisions about your health. If you’re experiencing joint pain or exploring your options, schedule a consultation with New Regeneration Orthopedics and understand the difference that experience, precision, and science can make.
References:
- Kon, E., et al. (2011). Platelet-rich plasma: intra-articular knee injections produced favorable results on degenerative cartilage lesions.
Knee Surgery, Sports Traumatology, Arthroscopy, 19(4), 528–535.
https://doi.org/10.1007/s00167-010-1238-6 - Hernigou, P., et al. (2013). Biologic augmentation of rotator cuff repair with mesenchymal stem cells during arthroscopy improves healing and reduces retear rate.
The Journal of Shoulder and Elbow Surgery, 23(11), 1429–1435.
https://doi.org/10.1016/j.jse.2014.02.030 - Chahla, J., et al. (2020). Concentration-dependent effect of bone marrow aspirate concentrate on chondrocytes and synoviocytes.
Cartilage, 13(2_suppl), 728S–736S.
https://doi.org/10.1177/1947603519895725 - Sibbitt, W.L., et al. (2011). Does sonographic needle guidance affect the clinical outcome of intra-articular injections?
The Journal of Rheumatology, 38(2), 210–217.
https://doi.org/10.3899/jrheum.100610 - Turner, L. (2021). The business of unproven stem cell interventions: a call for effective regulation.
Cytotherapy, 23(1), 2–5.
https://doi.org/10.1016/j.jcyt.2020.11.006 - U.S. Food and Drug Administration (FDA). (2020). FDA Warns About Stem Cell Therapies.
https://www.fda.gov/consumers/consumer-updates/fda-warns-about-stem-cell-therapies
