There is a level of transparency every patient should expect when considering a form of regenerative therapy, where a physician not only understands the power of what regenerative medicine is capable of but also doesn\u2019t dismiss its current limitations. Whether you\u2019re considering stem cells, exosomes, or platelet-rich plasma, science has a lot of catching up to do. Yet with billions on the table, the industry isn\u2019t slowing down to find out.<\/p>\n
The global regenerative medicine market is projected to grow from $58.40 billion this year to $360.84 billion by 2034, according to industry predictions<\/a>. More than 1,500 businesses promote stem cell treatments across the United States, according to research<\/a>. All the while, a 2024 study<\/a> found that a significant percentage of stem cell clinic websites disclosed neither the risks of treatment nor the limited evidence behind it, leaving patients misled and often taken advantage of.<\/p>\n Dr. David Karli,<\/a> founder of the Karli Health Institute in Miami, has spent two decades treating orthopedic injuries with various regenerative procedures, including stem cells, platelet-rich plasma, and exosomes, and he doesn\u2019t pretend the field is full of good actors.<\/p>\n \u201cThere\u2019s just so much misinformation, and there are so many claims out there,\u201d Karli tells Muscle & Fitness.<\/em> \u201cThe elephant in the room is that there\u2019s lots of money to be made, and you have people in it for the right reasons and for the wrong. The consumer needs to be able to weed out the difference between the two.\u201d<\/p>\n Karli says the process should start with a consultation built around a specific goal as opposed to aimlessly picking a treatment off a menu.<\/p>\n \u201cAre you here for regenerative medicine? Are you here for longevity and wellness? Or are you here for both?\u201d Karli begins.<\/p>\n Then he relies on imaging to pin down exactly the level of damage present before choosing a protocol. He drills deep to investigate, for example, what stage of arthritis it is. Whether it\u2019s one compartment or all three compartments. Whether there\u2019s an associated meniscal tear and what the patient\u2019s bone health underneath the cartilage looks like. He says, these all affect how to apply the cell therapy and where.<\/p>\n From there, Karli\u2019s clinic runs bloodwork focusing on a few key markers, like vitamin D, hs-CRP to quantify systemic inflammation, HbA1c, and hormone levels, to catch any deficiencies or imbalances that need addressing before moving forward with a protocol. However, he doesn\u2019t deny how much is still unsettled. \u201cThere are some [biomarkers] that empirically make sense in terms of tracking, but the science is still early, and we\u2019re also learning which ones are important and may have predictive value.\u201d<\/p>\n <\/p>\n Not every joint is a good candidate, and not every treatment has an equally predictable outcome.<\/p>\n \u201cSomeone who has grade-two knee arthritis is a perfect candidate, because they\u2019re not so early in the process, but they\u2019re not so far gone that it\u2019s a long shot either,\u201d Karli says. Grade three or four disease [bone-on-bone arthritis] can still respond, he adds, but the odds shift. \u201cThe more severe the disease, the less predictable our likelihood of success becomes.\u201d<\/p>\n Which protocol fits also depends on whether a patient is using their own cells or a donor product, which is a decision with its own tradeoffs. \u201cIf it\u2019s done in the right circumstances, using your own cells is a relatively low-risk procedure,\u201d Karli says. \u201cIf you\u2019re using a donor model, however, they are foreign and not invisible to the immune system and are good at evading the immune system.\u201d This is why the questions you ask must be taken seriously before treatment.<\/p>\n Additionally, using your own cells, caps how many sites can be treated at once. He says the limit is no more than two, which rules the approach out for anyone hoping to address several joints in a single visit.<\/p>\n He adds that in the United States, patient counseling is critical so they know that these are FDA-unapproved therapies. Donor cells haven\u2019t been vetted like a normal drug would through a prolonged FDA process. \u201cWe anecdotally have seen patients in offshore models do this for 20 years,\u201d he explained. \u201cAnd by and large, we\u2019re not seeing a lot of serious adverse events and deaths and really awful things, but they\u2019re also not reporting their adverse events, so we really don\u2019t truly know the long-term safety and efficacy.\u201d<\/p>\n Karli is careful not to oversell what any of this can do. \u201cWe\u2019re not at a point with regenerative medicine yet where we can reverse disease,\u201d he says, adding that the value is rather in improving function and quality of life for his patients. \u201cWe can manage disease effectively in most cases, not all, but most. We\u2019re not reversing it yet, but we\u2019re working toward it because ultimately we want a solution where we can undo the degenerative process and reverse it back to normal.\u201d<\/p>\n Karli measures success by duration. \u201cTo make this a cost-effective value to a patient spending lots of money, we\u2019ve got to capture the duration of lasting relief.\u201d Karli\u2019s clinic has spent years measuring protocols against two-year outcomes across thousands of treatments, feeding an AI model that predicts individual odds of success before a patient ever gets an injection. \u201cI want to be able to say you have an 86.7% chance of getting 70% relief at two years,\u201d Karli says. \u201cThat allows us to counsel powerfully to help the patient make a truly informed decision whether they should or shouldn\u2019t move forward.\u201d<\/p>\n Going beyond stem cells, there are a couple more options to consider. For simpler soft-tissue injuries like tendonitis, Karli says correctly dosed PRP performs well on its own. Inside a joint, he leans toward stem cells for their lasting power. \u201cWith PRP, you\u2019ve got to repeat them. They just don\u2019t hold that long,\u201d he says.<\/p>\n Exosomes, the cell-free \u201cmessenger\u201d therapies marketed as an alternative to stem cells, leave him intrigued but unconvinced that the science has caught up. \u201cThe way I like to explain exosomes to the consumer is a message in a bottle,\u201d he says. The open question, he says, is whether a lab can reliably reproduce the same signal a stem cell would release naturally inside an arthritic joint. \u201cIs it apples to apples? The answer is we don\u2019t know yet.\u201d<\/p>\n Karli wants people to have the awareness and 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\u2019re in good hands.<\/p>\n \u201cNumber one, is it legal?\u201d he starts. \u201cDoes the physician understand the law? Is this a side hustle for their practice, or is this what they do full time? How many patients have you treated? Are you collecting outcomes? Do you know your dose? How many platelets, how many white blood cells, how many monocytes?\u201d He points to dosing specifically as a place where patients get shortchanged without knowing it. \u201cIf someone comes to me and says, \u2018I tried PRP,\u2019 I say, \u2018Did your doctor know the dose?,\u2019 and if they say, \u2018No,\u2019 well, then how do I know if it worked or not?\u201d<\/p>\n For donor stem cells specifically, he adds a second round of questions. Since Florida passed a law effective July 1, 2025, licensed physicians now may perform stem cell therapy that the FDA hasn\u2019t approved, as long as it\u2019s used for orthopedics, wound care, or pain management, and falls within that physician\u2019s scope of practice.<\/p>\nTests to Run Before Determining Which Protocol Is Right<\/h3>\n
How Do You Know You\u2019re the Right Candidate<\/h3>\n
Ranking the Evidence<\/h3>\n
![\"Female](\"https:\/\/i0.wp.com\/www.muscleandfitness.com\/wp-content\/uploads\/2026\/07\/Female-consulting-a-doctor-about-stem-cell-therapy.jpg?w=1024\")
<\/p>\nMust-Ask Questions of the Doctor<\/h3>\n