For clinicians: talking with patients about stem cell clinics

Sooner or later a patient will ask about it. The patient might have knee osteoarthritis and a friend who "got stem cells" at a clinic across town, or a parent of a child with autism who has seen a testimonial video, or someone with multiple sclerosis or chronic lung disease who has run out of patience with standard care. The question usually arrives late in a visit, sometimes with a price quote already in hand.

These conversations are worth having well. Patients who feel dismissed tend to go anyway, and they stop telling their clinicians what they are doing. This guide covers what the clinics sell, how US regulation applies, what harms are documented, and a simple structure for the conversation.

Why patients ask

The market is large and visible. A 2021 analysis in Cell Stem Cell counted 1,480 US businesses marketing stem cell interventions directly to consumers, operating at 2,754 clinics, up from 351 businesses at 570 clinics in a 2016 count. They advertise on social media, in local newspapers and at free "educational" seminars. Common targets are orthopedic pain, neurological disease, lung disease, autoimmune conditions, autism and, more recently, "longevity."

Patients are rarely naive. Many have chronic conditions where approved treatments help only partly, and they have read that stem cell science is real and advancing, which it is. The difficulty is telling them that the product on offer is not the science they have read about.

What clinics typically sell

Prices are usually paid out of pocket, often thousands of dollars, and repeat treatments are common. Our explainer on mesenchymal stromal cells describes what these cells do in the body, and our page on stem cell technology covers how legitimate cell products are manufactured and tested.

The FDA framework in brief

Human cells, tissues and cellular and tissue-based products (HCT/Ps) are regulated under 21 CFR Part 1271. The key split is between two categories, named for sections of the Public Health Service Act.

361 products

These are regulated only to prevent disease transmission, through donor screening, registration and good tissue practice. To qualify, a product must meet all of these criteria:

1. Minimally manipulated.
2. Intended for homologous use, meaning it does the same basic job in the recipient as in the donor.
3. Not combined with another article, with narrow exceptions such as water or storage agents.
4. Either has no systemic effect and does not depend on living cells' metabolic activity for its main function, or is for autologous use, use in a first- or second-degree blood relative, or reproductive use.

351 products

Products that fail one or more of those tests are regulated as drugs or biologics. They need an investigational new drug application (IND) to be studied and an approved biologics license to be sold.

Most clinic products fail the test on manipulation or homologous use. Injecting processed amniotic tissue into a knee, or fat-derived cells into a vein for lung disease, is not a homologous use. The FDA gave the industry a period of enforcement discretion after its 2017 regenerative medicine guidance; that period ended on May 31, 2021.

The FDA's patient and consumer information page lists the product types it considers illegally marketed, including stem cells, stromal vascular fraction, umbilical cord blood, amniotic fluid, Wharton's jelly and exosomes. It also warns of documented risks including blindness, tumors and infections. Registration with the FDA is not approval, a point clinics sometimes blur.

The approved stem cell products are few and specific: licensed cord blood units for blood-forming transplants, Omisirge (2023), used in cord blood transplants for certain blood cancers, Lantidra (2023) for a narrow group of adults with type 1 diabetes, and Ryoncil (December 2024), the first approved mesenchymal stromal cell therapy, for steroid-refractory acute graft-versus-host disease in children.

What the courts have said

• United States v. US Stem Cell Clinic (11th Circuit, June 2021). The court upheld an injunction against a Florida clinic, holding that its SVF product was a drug. It did not fall under the "same surgical procedure" exception because the processed SVF was not the same as the fat removed, and it did not qualify as a 361 product because the clinic marketed it for many non-homologous uses.
• United States v. California Stem Cell Treatment Center (9th Circuit, September 2024). A district court had sided with the clinic in 2022. The appeals court reversed, holding that SVF is a drug subject to FDA premarket review and that the same surgical procedure exception did not apply.

Some states have moved the other way. Florida passed a law in 2025 allowing physicians to offer certain stem cell treatments not approved by the FDA for orthopedic conditions, wound care and pain management, with disclosure and consent requirements. State law does not change the federal rules the FDA enforces, and it says nothing about whether the treatment works.

Documented harms

These are published cases and investigations, not anecdotes:

• Vision loss: in 2017 the New England Journal of Medicine described three women with macular degeneration who received injections of fat-derived "stem cells" into both eyes at a US clinic. All three had severe bilateral vision loss; a year later their acuity ranged from 20/200 to no light perception.
• Tumor-like growth: a 2016 NEJM case report described a man who developed a mass of abnormal cells in his spinal cord after stem cell treatments obtained abroad.
• Bacterial infections: in 2018 the CDC reported 12 patients in Texas, Florida and Arizona hospitalized with bloodstream infections, joint infections and epidural abscesses after injections of umbilical cord blood products used for pain and orthopedic conditions. Unopened vials were contaminated.
• Exosome reactions: in December 2019 the FDA issued a safety notification after serious adverse events in Nebraska patients treated with unapproved exosome products.

There are quieter harms too: money spent, delays in effective treatment, and false hope that makes later conversations harder.

A conversation framework

Four steps, in order, take about as long as most medication discussions.

1. Ask

Find out what the patient has seen and what they hope for. "What did the clinic tell you it would do?" and "What would success look like for you?" Hopes are often concrete, such as walking without a cane, and that gives you something to work with.

2. Acknowledge

Name the frustration before the facts. "You've tried a lot, and the options we have haven't done enough." Acknowledging is not endorsing, and patients who feel heard are more likely to keep talking to you.

3. Explain the evidence

Be specific rather than global. Stem cell science is real, and a small number of cell therapies are approved for specific conditions. The product this clinic sells has not been shown to work for the patient's condition, is not FDA-approved for it, and has documented risks. Ask whether the clinic can show published, controlled results for this condition, and what happens, and who pays, if something goes wrong.

4. Point to legitimate options

Offer a next step rather than a closed door: optimizing current treatment, a referral, or a real clinical trial. Then make it clear that you want to hear what they decide either way.

Red flags to share with patients

• Treats many unrelated conditions with the same product
• Testimonials instead of published, controlled data
• Large upfront payment, packages or "financing"
• Claims of "no risk" or "your own cells, so it's safe"
• Says it is "FDA registered" as if that meant approved
• A "study" that charges participants for the treatment
• Pressure to decide quickly or a limited-time price
• No plan for follow-up care or complications

Our science desk piece on warning signs of unproven stem cell clinics is written for patients and can be shared directly.

Helping patients find real trials

ClinicalTrials.gov is the place to start, but a listing there is not a stamp of approval. Registration is largely self-reported, and some clinics register "patient-funded" studies as a form of marketing, a practice described in Regenerative Medicine in 2017. Signs of a legitimate trial include an academic or established industry sponsor, institutional review board oversight, an FDA IND for an investigational product, a defined control group, and, as a rule, no charge to participants for the experimental treatment. Our guide to reading a ClinicalTrials.gov listing walks through each field. The International Society for Stem Cell Research (ISSCR) also publishes patient resources and guidelines for clinical translation.

Reporting adverse events

If a patient is harmed after a clinic treatment, report it. Health professionals can file through MedWatch, the FDA's safety reporting program, online or with Form 3500; patients can file their own reports with Form 3500B. Include the product name, the clinic, the lot number if known, the route and the date. Reports to your state medical board are appropriate when a licensed practitioner is involved, and deceptive advertising can be reported to the Federal Trade Commission.

One practical habit makes the rest easier: add a routine question about supplements, injections and "regenerative" treatments to medication reconciliation. Patients who have already been to a clinic often say so only when asked directly.