What do stem cell clinics in the U.S. offer?

"Stem cells" in a U.S. clinic almost always means SVF (fat), BMC (marrow), PRP, or amniotic / umbilical product. None are FDA-approved for any condition outside the licensed hematopoietic indications.

How many stem cell clinics are there in the U.S.?

Americans imagine "stem cell therapy in the U.S." as something rare, maybe academic, maybe FDA-approved. The reality is that the last published census, in 2021, counted 2,754 stem-cell clinics operating in this country, almost none of which culture cells, and the gap between what they say and what they do is the whole reason the FDA exists.

2,754 Clinic locations, 2021 census
Run by 1,480 businesses. Up from 570 in 2016. The U.S. has more documented clinics of this kind than any other country.
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1 FDA-approved MSC therapy
Ryoncil (remestemcel-L), approved in December 2024 for steroid-refractory acute graft-versus-host disease in children. No MSC therapy is approved for orthopedic use. Everything else on the Section 351 path is a trial, not a commercial therapy.
2 Permanent injunctions granted
Regenerative Sciences (Regenexx), Colorado, 2012, over cultured bone marrow cells, upheld on appeal in 2014. US Stem Cell Clinic, Florida, 2019, on summary judgment. A third case, against California Stem Cell Treatment Center, went the FDA's way on appeal in 2024. The enforcement footprint is small relative to the industry size.

The wall of 2,754. Every U.S. clinic in the 2021 census, one dot.

If you walked into a U.S. stem-cell clinic at random, you would almost always be offered same-day SVF, BMC, PRP, or amniotic product. Not cultured cells. The blue and red dots are statistical noise against the Section 361 mainstream. The census counts clinics, not lanes: the split of dots between lanes is our illustration. Press a line of the key to find them.

Almost five times as many clinics in five years.

FDA enforcement actions, despite making headlines, have not slowed the industry.

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The two events marked on the chart (the 2017 FDA framework and the 2019 US Stem Cell injunction) saw the growth curve continue straight through them; the 2024 Ninth Circuit ruling in the California Stem Cell case and the 2025 SCOTUS cert denial extend the same precedent. Selective enforcement against a few egregious actors leaves the Section 361 mainstream undisturbed.

3,0002,2501,5007500 FDA Framework · 2017 US Stem Cell injunction · 2019 570 2,754 clinics
201620172018201920202021
U.S. clinics selling unapproved stem cell products, 2016 and 2021. Source: Turner, Cell Stem Cell, 2021.

Where are U.S. stem cell clinics concentrated?

California, Texas and Florida hold 35.9% of them. Three states concentrate the industry, driven by retiree density and state-level enforcement laxity. The rest tail off quickly.

  1. California347 clinics
  2. Texas333 clinics
  3. Florida310 clinics
  • Most clinics (CA, TX, FL)
  • Many (AZ, CO, NY, GA, NC, NV, WA)
  • Some
  • Few
Where the clinics are. The top three states are from the 2021 census; the other shading is our estimate.

What does "stem cell therapy in the U.S." mean, depending on the clinic?

Every U.S. operator falls into one of three lanes. The patient rarely knows which one their clinic is in, but the lane is what determines whether you're getting a real cellular product, a placebo-grade injection, or a federal-investigation candidate.

The FDA's "same-day autologous" loophole, no IND filed, no agency review, is where the entire commercial industry lives.

Lane 1 · The mainstream

Almost all

Section 361 / "homologous use"

Same-day, autologous, "minimally manipulated", the loophole. No IND, no FDA review.

Lane 2 · The trials

Trials only

Section 351 / IND-filed

Cultured, expanded, or allogeneic MSCs under an active FDA Investigational New Drug application, i.e. a clinical trial.

Lane 3 · Outside the system

A handful

Operating in violation

Clinics that culture or market cells as drugs without an IND. The category FDA injunctions and warning letters target.

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Lane 1Lane 2Lane 3
Cells used Your own BMC or PRP, drawn and reinjected same visit. SVF is sold here too, though the Ninth Circuit ruled one clinic's SVF a drug in 2024 Cultured MSCs (autologous or allogeneic, BM/AT/UC) Often expanded SVF/AD-MSC, amniotic, umbilical product
Cell count Varies by product. MSCs are a small fraction of the cells Tens to hundreds of millions per infusion, protocol-defined Claimed but rarely verified
Culture Not permitted. Cells out of body < 90 min cGMP-manufactured, characterized Yes, and that's the violation
Approved for None. "Off-label" only. Indication of the trial only None. Marketing claims often disease-specific.
Risk Low procedural, low biological signal Monitored, reported, characterized Highest, three patients went blind from one Florida clinic

The shorthand: Lane 1 is where almost everyone goes, Lane 2 is what most people think they're going to, and Lane 3 is what the FDA shuts down when it gets around to it. The marketing for all three sounds similar.

The Section 361 loophole, in one sentence

If the cells never leave the room and the operator can claim “homologous use,” the FDA’s drug-approval machinery never starts.

What every U.S. “stem-cell clinic” depends on.

The FDA line, in plain English

What do common stem cell clinic claims mean?

The marketing claim, and what that means.

"Our stem cell injection delivers millions of regenerative cells."

Total nucleated cells, mostly immune cells and RBCs. The actual MSC count is rarely disclosed, and is a small fraction of that total.

"FDA-registered facility."

"Registered" is an administrative listing for tissue establishments. It is not FDA approval, FDA inspection, or FDA clearance. A clinic registers a facility by filing a form.

"We use the same cells that hospitals use in clinical trials."

Almost never true. Trial-grade MSCs are cultured Section 351 products manufactured under IND. A Section 361 clinic legally cannot use that product. The cells in the clinic are minimally-manipulated autologous SVF or BMC.

"Treats arthritis, neuropathy, MS, autoimmune conditions, and more."

FDA does not authorize the product for any of these. "Off-label" injections occur, but disease-specific advertising is the most common FDA-warning-letter trigger.

"Umbilical-derived stem cells, donated from healthy mothers."

Usually a processed amniotic or cord-tissue product, frozen or freeze-dried. Published lab tests of commercial vials found no functioning MSCs. What you receive is closer to a growth-factor cocktail than to live MSCs.

Who runs stem cell clinics in the U.S.?

Three networks, and a long tail of independents. Most U.S. clinics are independent. But a handful of networks have built nationwide footprints and represent the most professional end of the Section 361 mainstream. They are not equivalent: physician training, protocols, and transparency all differ, but they share the lane.

One dot is five locations.

  • An orthopedic network

    ~70 locations
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    The largest U.S. orthopedic-MSC network. BMC-led, physician-owned, with the most published case-series data of any U.S. operator. Stricter culture rules than most.

    Cell source
    BMC + culture-expansion (limited cases)
    Specialty
    Orthopedic / joint
    Pubs
    ~30+ case series

  • An affiliate network

    ~100 affiliates
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    SVF-led, broad-indication. Two federal appeals courts (2021, 2024) have ruled a clinic's SVF a drug. Affiliated, not corporately owned.

    Cell source
    SVF (autologous fat)
    Specialty
    Multi-indication
    Pubs
    Internal follow-up records (not a formal registry)

  • A partner network

    ~45 partner clinics
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    Marketing-led network. Heavy on amniotic / umbilical products of varying provenance. Less protocol consistency across partners, quality depends entirely on which individual clinic.

    Cell source
    Amniotic / umbilical (mostly)
    Specialty
    Multi-indication
    Pubs
    None peer-reviewed

  • Independent solo practices

    ~600+ clinics
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    The long tail: typically an orthopedic, chiropractic, or integrative-medicine clinic offering PRP plus one of the cellular products on the side. Quality variance is enormous.

    Cell source
    Mix, usually SVF or BMC
    Specialty
    Whatever the MD does
    Pubs
    None

How does the FDA enforce the rules on stem cell clinics?

Selective, slow, but real. The FDA's posture on Section 361 vs Section 351 has hardened steadily since 2017, but the agency has chosen specific test cases rather than a categorical sweep. These are the moments that shaped the current landscape.

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FDA enforcement is selective. Two cases set the precedent that a clinic's SVF is a drug: US Stem Cell (2019) and California Stem Cell (Ninth Circuit 2024; the Supreme Court declined to hear it in 2025). Same-day, autologous products that are minimally manipulated and used homologously remain outside the drug rules, which is why every clinic markets exactly that.

The legitimate Section 351 path costs a fortune and eight years. The Section 361 loophole costs an LLC filing and a centrifuge. Guess which one the industry chose.

FDA enforcement in the clinic industry since 2012. Major actions only.

  1. Regenexx injunction

    A federal court rules that a Colorado clinic's cultured bone marrow cells are a drug and orders it to stop. The appeals court agrees in 2014. The first court precedent, and it was not about fat.

  2. "FDA Framework" guidance issued

    Clarified what counts as "minimal manipulation" and "homologous use." Gave the industry a 3-year grace period to comply.

  3. The FDA takes two clinics to court

    The government asks for permanent injunctions against US Stem Cell Clinic in Florida, where three patients were blinded by SVF injected into the eye for macular degeneration, and California Stem Cell Treatment Center.

  4. US Stem Cell injunction

    The first injunction over SVF. The court rules the clinic's SVF is a drug.

  5. California Stem Cell trial

    District court rules against FDA in the California Stem Cell Treatment Center case. Brief moment of legal cover for the SVF industry.

  6. Ninth Circuit reverses

    Appeals court sides with FDA. The clinic's SVF is a drug, and the same-surgical-procedure exception does not apply. The clearest precedent the agency now has.

  7. SCOTUS denies cert

    The Supreme Court declines to take the California Stem Cell appeal. The Ninth Circuit ruling stands.

Is a U.S. clinic product the same as a cultured MSC infusion?

A U.S. clinic product is not the same thing as a cultured-MSC infusion, whatever the headline numbers suggest.

The mental shortcut that treats a U.S. clinic and a cultured-MSC program as the same purchase misses what you're buying. U.S. products are almost universally same-day cell mixtures with low MSC content. A cultured, characterized MSC infusion delivers far more MSCs per dose. Comparing the two by the label, rather than by what is actually in the syringe, is the central error.

The cells themselves are usually a small fraction of what a properly cultured, dose-characterized infusion delivers.

The U.S. has more "stem-cell clinics" than anywhere on earth, and almost none of them deliver what their marketing implies.

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This is the central confusion behind why patients fly to Mexico. The 2,754 U.S. clinics are not analogues of a cultured-MSC program, they're operating in a different regulatory lane with a different product. They are not bad medicine in many cases; many are good orthopedic practices doing legitimate PRP and BMC injections. They are just not, in any meaningful sense, "stem cell therapy" as the international cell-therapy field uses the term.

If you understand that, the rest of the geography makes sense. The U.S. has thousands of clinics offering small-volume autologous biologics. Mexico has clinics offering cultured MSCs, regulated by COFEPRIS. Those are not competitors. They are different industries with overlapping marketing.

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