Every patient should expect a level of transparency when considering a form of regenerative medicine, where a physician not only understands the potential of regenerative medicine, but also does not dismiss its current limitations. Whether you’re considering stem cells, exosomes, or platelet-rich plasma, science has a lot to offer. Yet despite billions of dollars on the table, the industry isn’t slowing down to figure it out.
According to , the global regenerative medicine market is projected to grow from $58.40 billion this year to $360.84 billion by 2034. Industry Predictions. More than 1,500 businesses across the United States promote stem cell treatments, according to Research. all the time, a 2024 study found that a significant percentage of stem cell clinic websites disclosed neither the risks of the treatment nor the limited evidence behind it, leaving patients misled and often taken advantage of.
Dr. David Carli, The founder of the Carly Health Institute in Miami has spent two decades treating orthopedic injuries with a variety of regenerative processes including stem cells, platelet-rich plasma, and exosomes, and he doesn’t pretend that this field is full of good actors.
“There is a lot of misinformation out there and a lot of claims,” explains Carly. Muscle and health. “The elephant in the room is that there’s a lot of money to be made, and you have people for the right reasons and for the wrong reasons. The consumer needs to be able to distinguish between the two.”
tests run before determining which protocol is correct
Carly says the process should start with a consultation built around a specific goal, rather than aimlessly selecting a treatment from a menu.
“Are you here for regenerative medicine? Are you here for longevity and wellness? Or are you here for both?” Carly starts.
He then relies on imaging to accurately determine the level of damage present before choosing a protocol. For example, to check what stage of arthritis it is, he studies it in depth. Be it one box or all three boxes. What the associated meniscal tear is and what the patient’s bone health looks like beneath the cartilage. All of these influence how and where cell therapy is applied, he says.
From there, Carly’s clinic runs bloodwork focusing on a few key markers like vitamin D, hs-CRP, to measure systemic inflammation, HbA1c, and hormone levels to catch any deficiencies or imbalances that need to be addressed before moving forward with the protocol. However, he does not deny how much still remains unresolved. “There are some[biomarkers]that make sense in terms of tracking empirically, but the science is still early, and we’re also learning which ones are important and may have predictive value.”
How do you know you are the right candidate?
Not every joint is a good candidate, and not every treatment has equally predictable results.
“Someone who has grade-two knee arthritis is an ideal candidate, because they’re not so early in the process, but they’re also not so far along that it’s a long shot,” says Carly. Grade three or four disease (bone-on-bone arthritis) may still respond, he adds, but the chances change. “The more severe the disease, the less likely we are to succeed.”
Which protocol fits also depends on whether the patient is using their own cells or a donor product, which is a decision with its own tradeoffs. “If it’s done under the right conditions, using your own cells is a relatively low-risk procedure,” says Carly. “However, if you are using donor models, they are foreign and not invisible to the immune system and are good at evading the immune system.” This is why the questions you ask before treatment should be taken seriously.
Additionally, by using its own cells, it determines how many sites can be treated at once. He says the limit is no more than two, which rules out the approach for anyone hoping to address multiple couples in a single visit.
He further said that in the United States, patient counseling is important so that they know these are FDA-approved treatments. Donor cells have not been scrutinized through the lengthy FDA process like a normal drug. “We have seen patients do this in offshore models for the last 20 years,” he said. “And by and large, we’re not seeing a lot of serious adverse events and deaths and really terrible things, but they’re also not reporting their adverse events, so we don’t really know the long-term safety and efficacy.”
Carly is careful not to oversell much of what is made of it. “In terms of regenerative medicine, we are not yet at the point where we can reverse the disease,” he says, adding that the importance is in improving function and quality of life for his patients. “We can effectively manage the disease in most cases, not all, but in most. We are not reversing it yet, but we are working in that direction because ultimately we want a solution where we can undo the degenerative process and get it back to normal.”
ranking of evidence
Carly measures success in terms of duration. “To make it a cost-effective value for a patient who is spending a lot of money, we need to take into account the duration of lasting relief.” Carly’s clinic has spent years measuring the protocol against two-year results across thousands of treatments, introducing an AI model that predicts a patient’s individual odds of success before they even get the injection. “I like to say that you have an 86.7% chance of getting 70% remission in two years,” says Carly. “This allows us to provide powerful counseling to help the patient make a really informed decision about whether they should proceed or not.”
Moving beyond stem cells, there are a few more options to consider. For simple soft-tissue injuries like tendonitis, Carly says PRP taken correctly performs well on its own. Inside a joint, it turns to stem cells for its lasting strength. “With PRP, you have to repeat them. They don’t last that long,” he says.
Exosomes, the cell-free “messenger” therapy marketed as an alternative to stem cells, leaves him curious but unconvinced that science has caught up. “The way I explain exosomes to the consumer is it’s a message in a bottle,” he says. The open question, he says, is whether a laboratory can reliably reproduce the same signal that a stem cell naturally releases inside an arthritic joint. “Is it apples to apples? The answer is we don’t know yet.”
Be sure to ask questions to the doctor
Carly wants people to have the awareness and agency to distinguish a legitimate clinic from a room with a centrifuge and a marketing budget. He recommends that you prepare a list of questions to make sure you are in good hands.
“Number one, is it legal?” He starts. “Does the physician understand the law? Is this an extra effort for their practice, or do they work full-time? How many patients have you treated? Are you collecting results? Do you know your dosage? How many platelets, how many white blood cells, how many monocytes?” He specifically points to supplements as a place where patients may be missing doses without knowing it. “If someone comes to me and says, ‘I tried PRP,’ I say, ‘Does your doctor know the dosage?,’ and if they say, ‘No,’ well, how do I know if it works or not?”
For donor stem cells specifically, he adds another round of questions. Since Florida passed a law effective July 1, 2025, licensed physicians can now perform stem cell therapy that has not been FDA approved, as long as it is used for orthopedics, wound care, or pain management, and falls within that physician’s scope of practice.
the law saysHowever, cells must be obtained from FDA-registered facilities that are certified by a specific list of accrediting bodies (National Marrow Donor Program, American Association of Tissue Banks, among others), processed under current good manufacturing practices, and accompanied by a post-thaw viability report prior to use.
You should ask: “Did they screen the donor? Did they screen for communicable diseases? Did they screen for bacterial contaminants? Did they do a viability analysis? Can you show me the report?”
Carly says the industry standard for viability, the percentage of cells still alive at the time of injection, is 70%, which he considers very low. “I think it’s not acceptable anywhere,” he says. Their own clinic double-tests each shipment before it is used, which is not required by law. He says that a well-cultured stem cell that is well handled and managed through the freezing and thawing process should be able to achieve over 90% viability. “In these offshore models, if you’re not measuring feasibility, you don’t know what you’re getting,” he warns.
He also tells patients to ask whether the cells are being culture-expanded in the laboratory or simply concentrated and re-injected on the same day, especially for those who are being offered treatment in multiple joints in a single visit. “If they’re not expanding the culture, there’s no evidence to support it,” he says of that approach. “I wouldn’t recommend it.”
Finally, he says, ask about the injection itself. “Are you guiding it with ultrasound or X-rays? Have you been trained to be precise and safe with the implants?”
“If you start with these questions, you’re way ahead of the game,” he explains.
