There is a level of transparency that every patient should expect when considering a form of regenerative medicine, where the physician not only understands the power of regenerative medicine, but also does not deny its current limitations. Whether you’re thinking about stem cells, exosomes, or platelet-rich plasma, science has a lot to do. But with billions on the table, the industry isn’t slowing down to figure it out.
The global regenerative medicine market is expected to grow from USD 58.40 billion to USD 360.84 billion by 2034. industry forecasts. According to the US, more than 1,500 companies promote stem cell therapy across the United States research. During this time, A 2024 education found that a significant percentage of stem cell clinic websites disclosed neither the risks of the treatment nor the limited evidence behind it, misleading and often taking advantage of patients.
Dr. David Carley, The founder of Carley Health Institute in Miami has spent two decades treating orthopedic injuries with a variety of regenerative techniques, including stem cells, platelet-derived plasma and exosomes, and doesn’t pretend that the field is full of good actors.
“There’s just so much misinformation and so many claims out there,” Carly says Muscles and fitness. “The elephant in the room is that there’s a lot of money to be made, and you have people in it for the right reasons and for the wrong reasons. The consumer has to bridge the gap between the two.”
Tests to perform before determining which protocol is correct
Carly says the process should begin with a consultation built around a specific goal, as opposed to mindlessly choosing a treatment from a menu.
“Are you here for regenerative medicine? Are you here for longevity and health? Or are you here for both?” Carly begins.
He then relies on the imaging to determine the exact level of damage present before choosing a protocol. He drills to find out, for example, what stage of arthritis it is. Whether it is one section or all three sections. Whether there is an associated meniscal tear and what is the health of the patient’s bone beneath the cartilage. All of this will affect how and where cell therapy is applied, he says.
From there, Carly’s clinic does blood work that looks at several key indicators, such as vitamin D, hs-CRP to determine the amount of systemic inflammation, HbA1c, and hormone levels, to find any deficiencies or imbalances that can be addressed before moving forward with the protocol. However, he does not deny how uncomfortable he still is. “There are some (biomarkers) that make sense empirically in terms of tracking, 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 an equally predictable outcome.
“Someone with stage two knee arthritis is the perfect candidate because they’re not that early in the process, but they’re not that far along, which is also a long shot,” Carly says. Grade three or four disease (osteoarthritis) can still respond, he adds, but the odds are changing. “The more severe the disease, the more unpredictable our chances of success.”
Which protocol is appropriate also depends on whether the patient uses his own cells or a donor product, which is a decision with his own exchange. “If it’s done under the right conditions, using your own cells is a relatively low-risk procedure,” says Carly. “If you use a donor model, they are foreign and invisible to the immune system and are good at evading the immune system.” This is why your questions should be taken seriously before treatment.
In addition, using own cells, several sites can be treated at once. He says the limit is no more than two, which makes this approach prohibitive for anyone hoping to tackle multiple joints in one visit.
He adds that in the United States, it’s important to counsel patients so they know these treatments are not FDA-approved. Donor cells are not vetted through the FDA’s lengthy process like a conventional drug. “We’ve anecdotally seen patients doing this in offshore models for 20 years,” he said. “And generally, we don’t see a lot of adverse events and deaths and really scary things, but they also don’t report their adverse events, so we don’t really know long-term safety and efficacy.”
Carly is careful not to oversell any of these works. “We’re not yet at a point in regenerative medicine where we can reverse disease,” he said, adding that the value is more in improving function and quality of life for his patients. “We can effectively manage the disease in most cases, not all, but most. We’re reversing it now, but we’re working on it, because ultimately we want a solution where we reverse the degenerative process and return it to normal.”
Evidence rating
Carly measures success by persistence. “For this to be cost-effective for the patient who spends a lot of money, we need to achieve long-lasting relief.” Carly’s clinic has spent years measuring protocols against two-year results over thousands of treatments, feeding an AI model that predicts an individual’s likelihood of success before receiving an injection. “I’d say you have an 86.7% chance of getting 70% relief in two years,” Carly says. “This allows us to advise strongly to help the patient make a really informed decision about whether or not they should go forward.”
Moving beyond stem cells, there are several other options to consider. For simple soft tissue injuries like tendonitis, Carly says that properly administered PRP works well on its own. Inside the joint, he relies on stem cells for their lasting power. “With PRP, you have to repeat them. They don’t last as long,” he says.
Exosomes, the cell-free “messenger” therapies marketed as an alternative to stem cells, intrigue him, but aren’t sure the science has caught on. “The way I want to explain exosomes to the consumer is the message in the bottle,” he says. An open question, he says, is whether the lab can reproduce the same signal that a stem cell naturally produces inside an arthritic joint. “Are apples to apples? The answer is we don’t know yet.”
Questions to ask your doctor
Carly wants people to be aware and have the agency to separate 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 begins. “Does the doctor understand the law? Is this a side hustle for their practice or is it something they do all the time? How many patients have you treated? Do you collect results? Do you know your counts? How many platelets, how many white blood cells, how many monocytes?” He refers to the special dose as a place where patients change without knowing it. “If someone comes to me and says, ‘I tried PRP,’ I say, ‘Did your doctor know the dose?'” and if they say, “No,” then how do I know if it worked?
For donor stem cells, he adds a second round of questions. Since Florida passed a law effective July 1, 2025, licensed physicians can now perform stem cell therapy that has not been approved by the FDA, as long as it is used for orthopedics, wound care, or pain management and falls within that physician’s scope of practice.
It is stated in the lawHowever, cells must be obtained from an FDA-registered facility approved by one of a specific list of accreditation bodies (National Marrow Donor Program, American Association of Tissue Banks, etc.), processed under Good Manufacturing Practices, and with a post-thaw viability report before use.
You should ask, “Did they screen the donor? Did they screen for infectious diseases? Did they screen for bacterial contamination? 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 is too low for him. “I think it’s not acceptable,” he says. His own clinic retests each load before use, something that is not required by law. He adds that a well-cultured stem cell, well manipulated and manipulated through the freezing and thawing process, should be capable of more than 90% viability. “In these offshore models, if you don’t measure capacity, you don’t know what you’re getting,” he said.
He also tells patients to ask if the cells are expanded in the lab or concentrated and re-injected the same day, especially for someone who is being treated in multiple joints in one visit. “If they don’t expand the culture, then there is no evidence to support it,” he said of this approach. “I don’t recommend it.”
Finally, he says, ask about the injection itself. “Are you ultrasound or X-ray guiding it? Are you trained to be precise and safe with the implant?”
“If you just start with these questions, you’re way ahead of the game,” he says.
