Muse: a woman or a force personified as one, who is the inspiration for a creative artist. (Greek: mousa)

Profile: Mari Dezawa, Ph.D., a muse inspiring a creative new standard of stem cell misinformation, regulatory misconduct, and medical mischief, The Dezawa Standard.

The Dezawa Standard rests on three inspired confabulations:

• A research hub boasting “178 peer-reviewed records,” of which six are published human trials – as per usual, what happened in the mice stayed in the mice.
• Celebrity doctors and entrepreneurs who apparently failed to do scientific due diligence.
• Regulatory disclaimers that don’t equal regulatory compliance at the federal or state level.

Dezawa’s inspiration has captivated an all-star team. The MuseCell Innovations Scientific Advisory Board members include:

• Dr. Neal ElAttrache, orthopedic surgeon to the stars, including Tom Brady, Shohei Ohtani, Charlize Theron and many other high-profile patients.
• Peter Diamandis, Tony Robbins’s business partner and co-founder of Celularity, Inc. and an FDA warning letter awardee for making “innovative” (i.e., non-compliant) marketing claims for its Interfyl tissue matrix.

Spoiler alert: After Celularity burned through nearly $1 billion of investor capital without a single FDA approval (an accumulated deficit of $991.5 million at December 31, 2025, per its annual report), Diamandis became MuseCell Innovations’ strategic advisor in addition to his other entrepreneurial activities. And despite its FDA warning letter, Celularity announced a collaboration to manufacture Muse cells.

Kai Trump shot par believing “Scientific Advisory Board” member Dr. Jeff Wiegers’ muse that Muse cells are the best “immune-tolerated stem cells.”

Which Type of Muse Cell?

The celebrity-laden SAB has not told its social media followers that Muse cell clinical trials utilized donor (allogeneic) bone-marrow-derived Muse cells carrying two surface markers, SSEA-3 and CD105, at a purity of at least 50%,^[1] while the U.S. distributors market umbilical-derived Muse cells identified by one marker, SSEA-3, at a claimed purity of 70% or more.^[2],^[3]

Bluntly, even if the 6 in-human published Muse cell studies were credible, the MuseCells and MuseExosomes being sold non-compliantly in the U.S. are different from what was used in those studies.

A 2026 systematic review of the literature on human-derived Muse cells in Stem Cells Translational Medicine, whose senior author is the journal’s editor-in-chief, shows how far apart they are.^[4] SSEA-3-positive cells were scarce in every tissue, from under 1% to about 6% of the starting cells, and 1% in the one study that used umbilical cord. Most of the studies pulled the cells out with an antibody sorter; the rest used a stress culture the review calls unvalidated; at least ten used cells sorted from a single commercial bone-marrow cell line. The review found no standard method for identifying the cells, limited reproducibility between laboratories, and, among the studies it covered, no human comparison of Muse cells with ordinary stem cells.

Published In-Human Studies

The star-powered SAB doctors have failed to do an AI-verified review of the six published in-human studies. Had they done so, they would have discovered, much to their chagrin, that the results were likely no better than if the patients had only been treated with the standard of care. Consistent with the Dezawa Standard, our statistical analysis of the published studies raises serious questions about the reviewers’ credibility.

Are Muse Cells Stem Cells?

A legal issue for the SAB: Dezawa claims Muse cells are stem cells, and FDA regulations require robust and expensive clinical trials that establish safety and efficacy before the Agency grants a biologics license application (BLA) to market stem cells. The 2026 systematic review takes the stem cell claim as its premise but reports that functional proof of pluripotency is limited, that many of the studies come from the groups that first described the cells, and that the animal findings in stroke, newborn brain injury and ALS still await clinical confirmation.^[4]

Yet, the SAB’s 19 medical doctors, one naturopath and one PhD don’t seem to have (or want to have) a clue that MuseCell Innovations distributors and doctors treating patients with Muse cells are violating FDA and state medical board regulations, including in those states which have “right-to-try” stem cell laws.

Put another way, the SAB and the legion of doctors treating patients with MuseCells have demonstrated that they care more about profits than patients. And, the referring physicians, whether they make money or not, are accountable to their patients for believing the Dezawa Standard is backed by science and regulatory compliance when the MuseCell Innovations (MuseCells, Dezawa, or the Company) website provides no credible information to support its claims.

Part 2

Muse Cell Human Trials – A Forensic Review

Indications, patients and outcomes in the trials MuseCell Innovations cites, checked against the published papers. October 30, 2026.

MuseCell Innovations’ website and Library cite six published human trials of Muse cells. In them, 57 patients received cells and 10 received placebo, across six indications. All six tested CL2020, a donor bone marrow product from Life Science Institute (Mitsubishi Chemical Group), given intravenously in Japan. Mitsubishi ended the CL2020 program in February 2023. Only the stroke trial was randomized, and no trial of the cells or exosomes now supplied as Dezawa MuseCells and MuseExosomes has reported results.

The Stroke Claims

Three limits apply to the stroke result. First, the CL2020 arm started less impaired than the placebo arm: mean stroke-severity score (NIHSS, higher is worse) 9.8 against 14.1 and motor score (Fugl-Meyer total, higher is better) 32.1 against 11.5. Three of its 25 patients (12%) started at mRS 5 (bedridden), against 4 of the 10 on placebo (40%; both counts read from the paper’s Figure 3c), and in the MATCH trial cohort, patients at mRS 5 recovered independence less than half as often as those at mRS 4 (17% against 41%).^[5] The paper reports no marked effect of baseline NIHSS or mRS on the response rate in subgroup analyses. Second, with 10 placebo patients at one center, the 30-point difference against placebo missed statistical significance (P = 0.080). The site reports “a significant treatment effect compared with placebo”;^[6] the differences that reached significance were in other measures: the distribution of mRS scores at weeks 8 and 12, Fugl-Meyer upper-limb and total scores from week 4 to week 52, and quality-of-life scores at week 12.^[7] The Purita white paper calls return to work at 52 weeks statistically significant against placebo;^[8] at week 52 the paper reports significance for the Fugl-Meyer scores but not for the distribution of mRS scores or the share reaching mRS 1 or better. Third, the authors planned a phase 3 trial to confirm the result. A PubMed search on October 7, 2026, found none, and the CL2020 program has ended.

The Acute MI Result Against Standard Care

Standard care alone can produce the three patients’ 11-point gain in ejection fraction. Their blocked arteries were reopened a mean of about five hours after onset, with full flow restored (TIMI grade 3) in all three, and all three were taking an ACE inhibitor or ARB, a β-blocker and aspirin.^[9] Timely reopening (reperfusion) leaves salvaged muscle stunned, and ejection fraction rises as the stunning resolves, mostly within two weeks.^[10] With no cell therapy, about one in four STEMI patients gains 10 points or more between the artery-opening procedure (PCI) and six to eight months later,^[11] and 39% of those who start below 40% finish above 50%.^[12] The average gain is smaller: about 3 points when measured, as here, from several days after reperfusion.^[13],^[14] The CL2020 patients’ course fits recovery from stunning. Three-quarters of their gain was in place two weeks after the infusion, and the rise began within 24 hours, too soon for infused cells to have rebuilt heart muscle.^[9] Repeat two-dimensional echo readings can also differ by more than 10 points when heart function has not changed,^[15] and in this open-label study every reading was of a patient known to have received cells. With three patients and no control group, the study shows that three men recovered after a reperfused heart attack. It does not show that the cells added anything.

The Spinal Cord Injury Result Against Natural Recovery

The site presents the spinal cord injury trial as “function, not just safety,” saying its report “describes improvements in neurological classification, activities of daily living, and quality-of-life measures.”^[6] Looked at closely, the signal of efficacy goes missing. Every improvement is a change from the patient’s own baseline in a trial with no control group, and the authors write that “definitive conclusions on efficacy cannot be clearly drawn.”^[16] Set beside what patients with this injury recover without cell therapy, the results are unremarkable (Table 3).

The trial chose patients with a poor outlook: neck injuries (C4 to C7) with complete motor paralysis, touch sensation only and no pinprick sensation (modified Frankel B1/B2), unchanged three weeks after injury. A year after the infusion, 4 of the 10 had regained some movement below the injury, all of it too weak to be useful (grade C). None had reached grade D, the level that includes walking. One had worsened to a complete injury (grade A), and one had died of aspiration pneumonia, judged unrelated.^[16] On conservative care alone, half of the Frankel B patients with the least sacral sensation regained motor power, usefully in one of eight.^[17] Walking returned in 4.4% of motor-complete, sensory-incomplete patients who had no sacral pinprick sensation four weeks after injury^[18] and in 2 of 18 who had touch sensation only.^[19] Arm strength rose 8.3 points on the upper-extremity motor score; patients with complete cervical injuries gain 9 to 11 points in their first year with no cell therapy.^[20],^[21] Leg strength did not improve significantly after week 4. The quality-of-life index (EQ-5D) did not improve significantly at any time point; the gain was in a self-rated health score.^[16]

The Newborn Brain Injury Result Against Cooling Alone

The site introduces this trial with a statement attributed to Dr. Dezawa: “Every baby who received Muse cells has avoided mechanical ventilation — many developed normally and are attending kindergarten.”^[6] The paper does not say that the infants avoided ventilation. It reports a mean of 11 to 13 days of continuous respiratory management and cautions that respiratory support “may be influenced by pre-enrolment conditions.” Its follow-up ends at 78 weeks (18 months), so it cannot speak to kindergarten, and it states that “drawing conclusions regarding efficacy was not possible.”^[1] A PubMed search on October 8, 2026, found no later report on these infants.

The nine infants’ outcomes fall within what cooling alone produces in newborns with the same severity of injury. Eight had a moderate brain injury (encephalopathy) and one a severe one, and all had completed three days of cooling (therapeutic hypothermia), the standard treatment.^[1] In Japan’s national cooling registry, 4.5% of 291 infants with moderate encephalopathy had died by age three and 15.8% of the survivors had a major disability. Of those survivors, 89% had good motor function (GMFCS level 2 or better) and 92% needed neither breathing support nor tube feeding. Of the infants with severe encephalopathy, 82% died or had a major disability.^[22] For eight moderate cases and one severe case, those rates predict about two poor outcomes. At 18 months the trial reported one or two: one infant with poor motor function (GMFCS level III to V) and one with epilepsy, who may be the same child. Both were moderate cases. Seven of the eight moderate cases (88%) had good motor function, against the registry’s 89%, and the one severe case had good motor function and no epilepsy.^[1]

The paper’s own comparison is with 493 infants from the same registry: survival 100% against 92%, good motor function 89% against 77%, and normal development scores 67% against 33%.^[1] It is not like for like. The paper’s main text does not give the severity of injury among the 493. In the registry’s published three-year cohort about a quarter had severe encephalopathy,^[22] against one in nine here, and development scores were on file for only 170 of the 493.^[1] Entry to the trial also selected survivors. The cells were given 5 to 14 days after birth (mean 10.3) to infants with a heart rate of at least 100 and an oxygen saturation of at least 90%, and one referred infant was left out as too ill to transport. Brain injury scores on MRI were little changed, a mean of 1.4 before the cells and 1.0 at 78 weeks. Against Japan’s national growth survey the treated infants were slightly behind: 8 of 9 were walking against 100% of children that age, and 7 of 9 were speaking words against 95%.^[1]

The Epidermolysis Bullosa Result Against Placebo-Treated Wounds

The effect in the skin trial did not last. In five patients aged 17 to 49 with 13 ulcers, each present for more than four weeks, the reduction in ulcer area averaged 46.3% per patient four weeks after the infusion, with a confidence interval from −13.6% to 106.2% that includes no change at all. By week 12, the authors write, “the ulcer size returned to the baseline.”^[23] The one significant ulcer result, a mean fall of 9.98 cm² per patient in total ulcer area at week 4 (P = 0.017), came largely from one patient. She had about two-thirds of the ulcer area at the start and about three-quarters of the area lost (calculated from the paper’s table). Pain scores improved at week 2 only, itch scores rose at weeks 12 and 20, and the one skin biopsy showed no increase in type VII collagen, the protein that is faulty or missing in this disease.^[23]

Wounds like these often close with no active drug. Two randomized trials enrolled children and adults with several types of the disease and gave their control arms a drug-free cream or gel with dressings. Wounds present for at least 21 days closed completely in 54% of control patients within three months (51% in recessive dystrophic disease, and 37% when the wound was more than 30 days old)^[24] and in 29% within 45 days.^[25] In a third trial, in dystrophic disease, 20% of placebo-treated wounds had closed completely at three months.^[26] Complete closure is a harder test than shrinkage, and wounds in the first two trials had to measure 10 to 50 cm² at entry, against an average of about 2 cm² in three of the five patients here.^[23],^[24],^[25] The authors of the first series called the response “unexpectedly high” and said it could be due to the cream base or to the closer wound care that trial patients receive.^[24]

The ALS Result Against the Natural Course

On average the five patients with ALS were worse at 12 months on every clinical measure the paper reports. Their functional score (ALSFRS-R; 48 is normal) fell from 40.6 to 37.6 (P = 0.022), breathing capacity (forced vital capacity) fell from 100.4% to 93.7% of predicted (P = 0.012), muscle strength fell, and their quality-of-life score worsened from 75.6 to 94.4 (higher is worse; P = 0.002). Markers of inflammation in blood and spinal fluid rose. The main favorable finding is a slower rate of decline, 0.25 points a month after treatment against 0.47 before. It was calculated after the fact and was not statistically significant (P = 0.096), and the “before” rate comes from a three-month window in which a fall of at least one point was a condition of entry.^[27]

These patients were progressing slowly before they received cells. The authors say so: “ALS patients with a relatively slow rate of disease progression were included in this trial.”^[27] From first symptoms to first dose, about 23 months on average, they had lost 7.4 points, or about 0.3 points a month (calculated from the paper’s Table 1 and the three-month run-in, taking 48 as the score at onset). In a study of 203 patients, a rate below 0.47 at the first clinic visit marked the slowest of three prognostic groups.^[28] During trials the average patient loses 1.02 points a month,^[29] but one in four does not decline at all over six months and one in six over twelve.^[30] Two of these five did not decline over twelve months.^[27] The investigators who counted those plateaus concluded that “stable disease, especially for a short period of time, should not be interpreted as an ALS treatment effect.”^[30]

One comparison does favor the cells. The placebo arm of a Japanese trial of the ALS drug edaravone, which used nearly the same entry rules, lost 7.5 points in 24 weeks;^[31] these patients lost 1.6 points in six months.^[27] Five patients at one center, treated without blinding or a control group and slow before treatment, cannot carry that comparison, and the paper lists “the lack of comparisons, and post hoc analysis of ALSFRS-R slope” among its limits.^[27] No conclusion about efficacy can be drawn from it.

Dezawa MuseExosomes: No Human Studies

Dezawa MuseExosomes have not been studied in humans in any published report. The site’s exosome page cites two references, a laboratory analysis of what Muse cells secrete and a review article, and says its product-characterization statements “are not efficacy claims.”^[32] A PubMed search on October 7, 2026, found no clinical trial, case report or observational study of Muse cell exosomes. The one exosome study the site lists, a split-face study of MuseExosomes with hyaluronic acid, is shown as recruiting.^[6] The only human exposure in the sources reviewed is the pair of case reports in Table 2, where Muse-derived exosomes from an unnamed maker were infused together with cells, so no effect can be assigned to them. The page still offers the product to practitioners for skin and scalp use.

Appendix

Notes on the Evidence

• Product. CL2020 (nafimestrocel) was made by Life Science Institute from donor bone marrow and specified at 50% or more SSEA-3-positive, CD105-positive cells.^[7],^[1] MuseCell Innovations’ scientific brief describes its cells as umbilical cord-derived,^[33] and its registry record cites enrichment to 70% or more SSEA-3-positive cells.^[2]
• All six trials tested Life Science Institute’s product; the Research Hub lists them under “Clinical Trials of Muse Cells.”^[34] The site nonetheless presents them as evidence for Dezawa MuseCells. Its notice to U.S. users says “All published information utilizes Dezawa MuseCells® that are manufactured in accordance with MCI’s patented processes,” and also that “No claims are made regarding safety or effectiveness for any specific clinical application.”^[6] The company’s stated basis is the method, not the tissue: its chief executive says Dezawa MuseCell identity “is defined by manufacture under the licensed Dezawa Method and conformance to MCI’s product specifications—not by the anatomical source alone.”^[35] Apart from the case reports in Table 2, whose cell source is not stated, the pages reviewed cite no human study of cells from any other maker.
• A mixture, not pure Muse cells. CL2020 was specified as at least 50% Muse cells, which carry two surface markers (SSEA-3 and CD105). The rest of each dose was ordinary mesenchymal stem cells (MSCs), which carry CD105 but not SSEA-3.^[1] In the newborn trial’s high dose of 15 million cells, as many as 7.5 million could have been ordinary MSCs. Dezawa’s own group describes those cells as essentially identical to conventional MSCs.^[36] No trial included a group given ordinary MSCs alone, so the trials cannot show which cell type, if either, produced any change. The two have been compared only in animals;^[37],^[38] a PubMed search on October 9, 2026, found no human comparison. A 2026 systematic review counted 13 such comparisons, all in animals or the laboratory.^[4]
• Program ended. Mitsubishi Chemical Group announced on February 14, 2023, that it was ending development of CL2020. It cited the clinical development status, the timeline to commercialization and its future pharmaceutical business strategy.^[39] CL2020 had been in Japanese trials for seven diseases.^[40]
• Safety claims. The Purita white paper says the trials produced no reports of tumor formation and no serious adverse events attributable to the cells.^[8] The stroke trial classed one grade 4 status epilepticus as a serious adverse reaction.^[7] SHIELD recorded one testicular yolk sac tumor, which genotyping showed arose from the infant’s own tissue.^[1]
• Routes and orthopedics. All six published trials gave the cells intravenously. The site’s treatment page says some treatment plans add local injection or intranasal administration,^[41] and the orthopedics white paper says cells and exosomes “have been shown to have positive results” by intradiscal, facet-joint and epidural injection, with no citation, patient count or data.^[42] The trials page itself states that no published human Muse cell trial has studied cartilage regeneration.^[6]

Published Trials

Unless noted, each patient received one intravenous infusion of 1.5 × 10⁷ CL2020 cells, without HLA matching or immunosuppression.^[43] Rows run from most to fewest patients.

Table 1. Published human trials of CL2020

An adverse reaction is an adverse event for which a link to treatment could not be ruled out. ALSFRS-R, Revised Amyotrophic Lateral Sclerosis Functional Rating Scale; CHIT-1, chitotriosidase-1; CI, confidence interval; CSF, cerebrospinal fluid; GMFCS, Gross Motor Function Classification System; γ-GT, γ-glutamyltransferase; HLA, human leukocyte antigen; IL-6, interleukin-6; ISNCSCI, International Standards for Neurological Classification of Spinal Cord Injury; LVEF, left ventricular ejection fraction; MACE, major adverse cardiovascular events; mRS, modified Rankin Scale (0, no symptoms, to 6, death); NIHSS, National Institutes of Health Stroke Scale; PCI, percutaneous coronary intervention; RSV, respiratory syncytial virus; S1P, sphingosine-1-phosphate; SCIM, Spinal Cord Independence Measure; STEMI, ST-elevation myocardial infarction; TNF-α, tumor necrosis factor-α.

Other Human Data on the Site

The site cites two further sources of human data. Neither is a controlled trial.

Table 2. Case reports and registry

• Unpublished trials. CL2020 was tested in two further trials with no published results. One was a placebo-controlled confirmatory trial in STEMI: phase 2/3, registered in 2019, with ejection fraction as its primary outcome.^[45],^[46] The other enrolled patients with COVID-19 acute respiratory distress syndrome (jRCT2043210005).^[43],^[1] A PubMed search on October 7, 2026, found no results paper for either.
• Not tabled. The Research Hub lists five observational studies that counted patients’ own Muse cells: after myocardial infarction, stroke and liver surgery, in myocarditis, and during cardiac rehabilitation. No cells were given.^[34] The Library also links a July 2026 company press release that quotes one patient treated for craniocervical instability; it reports no outcome measures.^[47] Outside the site, a 40-patient randomized trial in Parkinson’s disease tested adipose-derived SSEA-3-positive cells, which its authors distinguish from Muse cells. It did not demonstrate efficacy.^[48]

Table 3. Spinal cord injury outcomes with CL2020 and without cell therapy

CL2020 figures are changes from a baseline three weeks after injury; the grade breakdown is from the paper’s Discussion and Figure 1. The comparison series enrolled patients within 48 hours (Katoh and el Masry) or 72 hours (Crozier et al.) of injury, and graded them within 7 days (Marino et al.) or at 4 weeks (Oleson et al.). Earlier grading leaves more spontaneous recovery still to come. Grades follow the Frankel and ASIA scales: A, complete; B, sensation only; C, movement too weak to be useful; D, useful movement. No natural-history figure was found for the independence score (SCIM). CI, confidence interval.

U.S. regulatory status: a section 351 product

Under federal law Dezawa MuseCells are a biological product that needs an approved biologics license application (BLA) before it can be marketed, and the same holds for exosomes used to treat a disease or condition. A human cell product is regulated solely under section 361 of the Public Health Service Act, with no premarket approval, only if it meets all four criteria in 21 CFR 1271.10(a): it is minimally manipulated, intended for homologous use, not combined with another article, and either has no systemic effect and does not depend on the metabolic activity of living cells, or is for use in the donor, a first- or second-degree blood relative, or reproduction.^[49] Dezawa MuseCells are living donor (allogeneic) cells infused intravenously without HLA matching, and are said to travel to injured tissue and replace lost cells.^[41] A product that acts through the body in that way and is not reserved for the donor or a close relative fails the fourth criterion. A product that fails is “regulated as a drug, device, and/or biological product under the act and/or section 351 of the PHS Act,”^[50] and section 351 bars a biological product from interstate commerce unless a biologics license is in effect.^[51] FDA states that exosomes “used to treat diseases and conditions in humans are regulated as drugs and biological products” and “are subject to premarket review and approval requirements.”^[52] The company’s orthopedics white paper describes injecting exosomes into discs, facet joints and the epidural space.^[42] Before licensure, FDA says an investigational new drug application (IND) is needed to administer such products legally.^[53]

Based on the Company’s own description, the cells fail the homologous-use criterion as well. Homologous use means the product performs “the same basic function or functions in the recipient as in the donor.”^[54] The company’s launch release offers the cells to practitioners treating “stroke, heart disease, neurodegeneration, and age-related decline,”^[47] and FDA’s guidance gives the parallel case: giving bone marrow cells to limit damage after a heart attack “is not homologous use because limiting ventricular remodeling is not a basic function of bone marrow.”^[55] The same guidance says that growing selected cord blood cells in culture “to achieve large numbers of cells” would generally be more than minimal manipulation, and the company describes an enrichment step that “selects the stress-enduring cell phenotype”^[3] and refers to “MuseCell® cultures.”^[32] In warning letters of May 26, August 14 and September 11, 2026, FDA applied the fourth criterion to donor umbilical cord blood products, on the ground that each depends on the metabolic activity of living cells and is not for the donor or a close blood relative.^[56],^[57],^[58]

Neither product is licensed. FDA’s list of approved cellular and gene therapy products, current as of September 17, 2026, includes no Muse cell or exosome product,^[59] and FDA states that “There are currently no FDA-approved exosome products.”^[60] The company says so itself. Its trials page states that “Muse cell-based products are not approved by the FDA for any indication,”^[6] and its exosome page states that the products “have not been evaluated or approved by the United States Food and Drug Administration (FDA).”^[32] It announced a U.S. launch in July 2026 through centers in Florida, Utah, Tennessee and Georgia, offering “cellular therapies for aesthetics, performance, and the treatment of diseases,”^[47] and its notice to U.S. users points to state law: “certain states permit the provision of certain stem cell therapies not approved by the FDA.”^[6] Its own disclaimer adds that clinical use “must comply with all applicable federal and state laws and regulations.”^[6] None of the 17 site pages searched on October 8, 2026, mentions an IND or a biologics license.

A cosmetic label does not change the status of the exosome product if it is promoted or used to treat. FDA’s cell and tissue rules do not cover “secreted or extracted human products, such as milk, collagen, and cell factors,”^[54] and FDA states that whether a product is a cosmetic or a drug “is determined by a product’s intended use.”^[61] In 2023 FDA warned Kimera Labs over exosome products that the firm said were for cosmetic use, stating that “a valid biologics license must be in effect” to market them.^[62] The company’s own material pulls both ways. Its notice to U.S. users says the products “are not intended to diagnose, treat, cure, or prevent any disease or medical condition,”^[6] while its launch release names “Treatment of Diseases” as one of three lines of business.^[47]

The World Health Organization name that the company cites carries no regulatory weight. The launch release says the therapy “has been awarded an International Nonproprietary Name (INN) designation by the WHO, marking a key milestone in its global regulatory pathway.”^[47] An INN is a generic name. WHO’s lists of proposed names state that inclusion “does not imply any recommendation of the use of the substance in medicine or pharmacy,”^[63] and the name in question, nafimestrocel, was given to the cells in CL2020.^[1]

FDA enforcement and the courts

FDA’s period of enforcement discretion for lower-risk cell and tissue products ended on May 31, 2021, and products given by intravenous infusion were an enforcement priority throughout.^[55],^[64] In the agency’s words, “An approved BLA is required to lawfully market these products.”^[64] Two federal appeals courts have upheld FDA’s authority over stem cell products made and given in clinics, the Eleventh Circuit in 2021 and the Ninth Circuit in 2024,^[65],^[66] and the Supreme Court declined to review the Ninth Circuit ruling on October 14, 2025.^[67] Both cases concerned cells taken from a patient’s own fat. The exception argued in them applies only to an establishment that “removes HCT/P’s from an individual and implants such HCT/P’s into the same individual during the same surgical procedure,”^[68] which donor cells cannot meet. Between February and September 2026 FDA sent warning letters over donor cord and exosome products to firms in Nevada, New Jersey, Arizona and California.^[56],^[57],^[58],^[69]

None of those letters is addressed to MuseCell Innovations, and web searches on October 7 and 8, 2026, found no FDA letter to the company or to its two U.S. distributors. Celularity, the New Jersey firm with which the company announced a U.S. manufacturing collaboration in August 2026,^[35] received a warning letter on December 1, 2025 over one of its own placental tissue products, which FDA found to be an unapproved new drug and an unlicensed biological product.^[70] The law is more certain than its enforcement. A March 2026 commentary by three authors at two law schools warns that the leadership of the Department of Health and Human Services may pull FDA back from this field.^[71]

The state laws the company cites

The company’s notice to U.S. users says that “the states of Florida, Georgia, Tennessee, and Utah, and Texas permit the provision of certain stem cell therapies, including Muse Cells, provided the various conditions of a particular state’s requirements are met.”^[6] These laws set out what a state-licensed practitioner may do without state discipline (Table 4). None of them licenses a product, and a state law cannot supply the federal license that section 351 requires.^[51],^[72] The products are in interstate commerce: the company says its two U.S. distributors serve practitioners “across the United States.”^[3] The Florida Senate’s staff analysis warned that its bill “may expose providers to federal regulatory enforcement,”^[73] and a Holland & Knight review calls the Florida law “in direct conflict with federal law.”^[72] FDA warned a Florida firm over umbilical cord and exosome products on August 15, 2025, six weeks after that law took effect.^[74]

Table 4. The five state laws named in the company’s notice

The Tennessee act was read through a legislative tracker’s record and a caucus press release, not the enacted text. A 2026 Florida act (chapter 2026-124) lets podiatric physicians use cell and tissue products that FDA has not approved, under conditions of its own.^[82] Fla. Stat., Florida Statutes; O.C.G.A., Official Code of Georgia Annotated.

Set against the company’s own material, the laws cover less than its notice suggests. Florida, where 19 of the 31 U.S. centers in the company’s directory are located,^[83] allows unapproved stem cell therapy only for orthopedics, wound care or pain management. Stroke, heart disease, neurodegeneration and aesthetics fall outside it. Texas requires a clinical trial under review board oversight, and the company’s registry is an observational study of routine care.^[2] The Florida and Georgia laws cover “afterbirth placental perinatal” stem cells and cell and tissue products, which they define in the words of the federal rule, and Utah’s adopts the federal definition by reference. That definition leaves out secreted products. None of the three laws mentions exosomes, and on this review’s reading none reaches them.^[75],^[76],^[80] The directory lists no center in Georgia.^[83]

California

California is not one of the five states, and the company’s directory lists no center there.^[83] This review found no California law that permits unapproved stem cell therapy. The state’s statute on the subject is a disclosure rule. Business and Professions Code section 684 requires a licensed practitioner who performs a stem cell therapy that is subject to FDA regulation but not FDA-approved to post a notice and give it to the patient in writing: “This health care practitioner performs one or more stem cell therapies that have not been approved by the United States Food and Drug Administration.” The rule covers cell and tissue therapies that neither meet the section 361 criteria nor fit a federal exception such as same-procedure use. It exempts only a practitioner with FDA clearance for an investigational new drug or device, and it carries a fine of up to $1,000 for a second or later violation.^[84]

State drug law applies to the product itself. The Sherman Food, Drug, and Cosmetic Law defines a drug as an article intended to treat or prevent disease or to affect the structure or function of the body, and a new drug as one not generally recognized by experts as safe and effective for its labeled or advertised use.^[85] No person may sell, deliver or give away a new drug unless it has an approved federal new drug application, a license under the Public Health Service Act, or an application approved by the state Department of Public Health.^[86] The same law makes it unlawful to advertise a drug as having any effect on a list of conditions that includes heart and vascular diseases, bone or joint diseases, paralysis and disorders of the immune system. The exceptions are a product approved or licensed for that use, advertising sent only to health professionals, and non-commercial public health education.^[87] A tissue bank operating in California, meaning any place that collects, processes, stores or distributes human tissue for transplantation, needs a state license. The relevant exemptions for storing tissue are narrow: an FDA-approved device or licensed biologic that a physician obtains from a California-licensed tissue bank, allograft tissue from a state-licensed bank held in a hospital or regulated outpatient setting, and investigational tissue at a clinical trial site.^[88] Right to Try laws offer no route without an FDA-authorized trial. The federal act and California’s both require a completed phase 1 trial and a product still under clinical investigation; the federal act also accepts a filed marketing application.^[89],^[90]

Federal agencies have enforced federal law against California firms. The Ninth Circuit case was brought against a California company.^[67] FDA’s warning letter of September 11, 2026 went to a cord blood firm in Irvine.^[58] In 2018 the Federal Trade Commission obtained a $3.31 million judgment, suspended in part, against a California physician who marketed “amniotic stem cell therapy.”^[91] A California licensee’s advertising is also subject to Business and Professions Code section 651, which bars a scientific claim “that cannot be substantiated by reliable, peer reviewed, published scientific studies.”^[92] The Medical Board of California, which must report stem cell complaints each year, recorded three complaints and three disciplinary actions in fiscal year 2023–24, and one complaint and no disciplinary action in 2024–25.^[84],^[93]

Sources and method

This review covers the MuseCell Innovations home, Library, Research Hub, Clinical Trials, Safety & Mechanism, What Are Muse Cells, Muse Exosomes and Muse Stem Cell Treatment pages, the three papers in the Library and the two company press releases it links, as read on October 7, 2026, the physicians page as read on October 8, 2026, and the patients page (the center directory) as read on October 30, 2026. Pages on the company site carried a “staging preview” banner when read, so the public site may differ in places. Trial figures were checked against the full texts in PubMed Central and J-STAGE. Bibliographic details and the comparator figures in the stroke, acute MI, spinal cord injury, newborn, epidermolysis bullosa and ALS sections came from PubMed and PubMed Central. The 2026 systematic review by Garzón and colleagues was read in full through PubMed Central on October 28, 2026; the count of studies using one commercial cell line and the statement that its 13 Muse-versus-MSC comparisons were all in animals or the laboratory are this review’s reading of its tables. The supplementary tables of the stroke and newborn papers could not be opened. The one-in-four figure for heart attack patients is read from the upper quartile of the cohort cited, a gain of 10.0 points. Three figures are calculated from the papers’ own tables: the number of poor outcomes the registry predicts for the nine newborns (2.4 counting deaths, 2.0 among survivors), one patient’s share of the ulcer area, and the ALS patients’ rate of decline from first symptoms. The regulatory sections apply the statutes, regulations, court rulings and agency statements cited, as they stood on October 8, 2026, to the company’s own description of its products. This review found no FDA determination about these products. The two appellate decisions and the Tennessee act were read through summaries, not the full texts, and the statement that three state laws do not reach exosomes is this review’s reading of their definitions. These sections are not an FDA determination or legal advice.

Endnotes

[1] Sato, Yoshiaki, et al. “Safety and Tolerability of a Muse Cell-Based Product in Neonatal Hypoxic-Ischemic Encephalopathy with Therapeutic Hypothermia (SHIELD Trial).” Stem Cells Translational Medicine, vol. 13, no. 11, 2024, pp. 1053–66, https://doi.org/10.1093/stcltm/szae071.

[2] MuseCell Innovations Pte Ltd. “Registry of Outcomes of Dezawa MuseCells.” ClinicalTrials.gov, U.S. National Library of Medicine, identifier NCT07645989, first posted 12 June 2026, https://clinicaltrials.gov/study/NCT07645989. Record read through the MedPath mirror, https://trial.medpath.com/clinical-trial/71a650e6d8f0c136/nct07645989-registry-outcomes-dezawa-musecells.

[3] “Authentic Dezawa MuseCells® for Clinics: Qualified Sources.” MuseCell Innovations, 2026, https://musecellinnovations.com/physicians. Accessed 8 Oct. 2026.

[4] Garzón, Ingrid, et al. “Isolation and Characterization of Human Multilineage-Differentiating Stress-Enduring Cells for Use in Tissue Engineering: A Systematic Review.” Stem Cells Translational Medicine, vol. 15, no. 7, 2026, article szag039, https://doi.org/10.1093/stcltm/szag039. Anthony Atala, the journal’s editor-in-chief, is the senior author.

[5] Hankey, G. J., et al. “Rate, Degree, and Predictors of Recovery from Disability following Ischemic Stroke.” Neurology, vol. 68, no. 19, 2007, pp. 1583–87, https://doi.org/10.1212/01.wnl.0000260967.77422.97.

[6] “Muse Cell Clinical Trials: Published Human Research.” MuseCell Innovations, 2026, https://musecellinnovations.com/muse-cell-clinical-trials. Accessed 7 Oct. 2026.

[7] Niizuma, Kuniyasu, et al. “Randomized Placebo-Controlled Trial of CL2020, an Allogenic Muse Cell–Based Product, in Subacute Ischemic Stroke.” Journal of Cerebral Blood Flow & Metabolism, vol. 43, no. 12, 2023, pp. 2029–39, https://doi.org/10.1177/0271678X231202594.

[8] Purita, Joseph. Authentic Dezawa MuseCells: Why Source, Protocol, and Science All Matter. MuseCell Innovations, May 2026, https://musecellinnovations.com/articles/purita-authentic-musecells.pdf. White paper. Date per the site’s Library page.

[9] Noda, Toshiyuki, et al. “Safety and Efficacy of Human Muse Cell-Based Product for Acute Myocardial Infarction in a First-in-Human Trial.” Circulation Journal, vol. 84, no. 7, 2020, pp. 1189–92, https://doi.org/10.1253/circj.CJ-20-0307.

[10] Solomon, Scott D., et al. “Recovery of Ventricular Function after Myocardial Infarction in the Reperfusion Era: The Healing and Early Afterload Reducing Therapy Study.” Annals of Internal Medicine, vol. 134, no. 6, 2001, pp. 451–58, https://doi.org/10.7326/0003-4819-134-6-200103200-00009.

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[12] Abou, Rachid, et al. “Effect of Guideline-Based Therapy on Left Ventricular Systolic Function Recovery after ST-Segment Elevation Myocardial Infarction.” The American Journal of Cardiology, vol. 122, no. 10, 2018, pp. 1591–97, https://doi.org/10.1016/j.amjcard.2018.07.035.

[13] Traverse, Jay H., et al. “Effect of the Use and Timing of Bone Marrow Mononuclear Cell Delivery on Left Ventricular Function after Acute Myocardial Infarction: The TIME Randomized Trial.” JAMA, vol. 308, no. 22, 2012, pp. 2380–89, https://doi.org/10.1001/jama.2012.28726.

[14] Schächinger, Volker, et al. “Intracoronary Bone Marrow–Derived Progenitor Cells in Acute Myocardial Infarction.” The New England Journal of Medicine, vol. 355, no. 12, 2006, pp. 1210–21, https://doi.org/10.1056/NEJMoa060186.

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[16] Koda, Masao, et al. “Safety and Feasibility of Intravenous Administration of a Single Dose of Allogenic-Muse Cells to Treat Human Cervical Traumatic Spinal Cord Injury: A Clinical Trial.” Stem Cell Research & Therapy, vol. 15, no. 1, 2024, article 259, https://doi.org/10.1186/s13287-024-03842-w.

[17] Katoh, S., and W. S. el Masry. “Motor Recovery of Patients Presenting with Motor Paralysis and Sensory Sparing following Cervical Spinal Cord Injuries.” Paraplegia, vol. 33, no. 9, 1995, pp. 506–09, https://doi.org/10.1038/sc.1995.110.

[18] Oleson, Christina V., et al. “Prognostic Value of Pinprick Preservation in Motor Complete, Sensory Incomplete Spinal Cord Injury.” Archives of Physical Medicine and Rehabilitation, vol. 86, no. 5, 2005, pp. 988–92, https://doi.org/10.1016/j.apmr.2004.09.031.

[19] Crozier, K. S., et al. “Spinal Cord Injury: Prognosis for Ambulation Based on Sensory Examination in Patients Who Are Initially Motor Complete.” Archives of Physical Medicine and Rehabilitation, vol. 72, no. 2, 1991, pp. 119–21. PubMed, https://pubmed.ncbi.nlm.nih.gov/1991012/.

[20] Steeves, J. D., et al. “Extent of Spontaneous Motor Recovery after Traumatic Cervical Sensorimotor Complete Spinal Cord Injury.” Spinal Cord, vol. 49, no. 2, 2011, pp. 257–65, https://doi.org/10.1038/sc.2010.99.

[21] Marino, Ralph J., et al. “Upper- and Lower-Extremity Motor Recovery after Traumatic Cervical Spinal Cord Injury: An Update from the National Spinal Cord Injury Database.” Archives of Physical Medicine and Rehabilitation, vol. 92, no. 3, 2011, pp. 369–75, https://doi.org/10.1016/j.apmr.2010.09.027.

[22] Tsuda, Kennosuke, et al. “Three-Year Outcome following Neonatal Encephalopathy in a High-Survival Cohort.” Scientific Reports, vol. 12, no. 1, 2022, article 7945, https://doi.org/10.1038/s41598-022-12091-x.

[23] Fujita, Yasuyuki, et al. “Intravenous Allogeneic Multilineage-Differentiating Stress-Enduring Cells in Adults with Dystrophic Epidermolysis Bullosa: A Phase 1/2 Open-Label Study.” Journal of the European Academy of Dermatology and Venereology, vol. 35, no. 8, 2021, pp. e528–31, https://doi.org/10.1111/jdv.17201.

[24] Murrell, Dedee F., et al. “Wound Closure in Epidermolysis Bullosa: Data from the Vehicle Arm of the Phase 3 ESSENCE Study.” Orphanet Journal of Rare Diseases, vol. 15, no. 1, 2020, article 190, https://doi.org/10.1186/s13023-020-01435-3.

[25] Kern, Johannes S., et al. “Efficacy and Safety of Oleogel-S10 (Birch Triterpenes) for Epidermolysis Bullosa: Results from the Phase III Randomized Double-Blind Phase of the EASE Study.” British Journal of Dermatology, vol. 188, no. 1, 2023, pp. 12–21, https://doi.org/10.1093/bjd/ljac001.

[26] Guide, Shireen V., et al. “Trial of Beremagene Geperpavec (B-VEC) for Dystrophic Epidermolysis Bullosa.” The New England Journal of Medicine, vol. 387, no. 24, 2022, pp. 2211–19, https://doi.org/10.1056/NEJMoa2206663.

[27] Yamashita, Toru, et al. “Safety and Clinical Effects of a Muse Cell-Based Product in Patients with Amyotrophic Lateral Sclerosis: Results of a Phase 2 Clinical Trial.” Cell Transplantation, vol. 32, 2023, article 9636897231214370, https://doi.org/10.1177/09636897231214370.

[28] Labra, Julie, et al. “Rate of Disease Progression: A Prognostic Biomarker in ALS.” Journal of Neurology, Neurosurgery & Psychiatry, vol. 87, no. 6, 2016, pp. 628–32, https://doi.org/10.1136/jnnp-2015-310998.

[29] Atassi, Nazem, et al. “The PRO-ACT Database: Design, Initial Analyses, and Predictive Features.” Neurology, vol. 83, no. 19, 2014, pp. 1719–25, https://doi.org/10.1212/WNL.0000000000000951.

[30] Bedlack, Richard S., et al. “How Common Are ALS Plateaus and Reversals?” Neurology, vol. 86, no. 9, 2016, pp. 808–12, https://doi.org/10.1212/WNL.0000000000002251.

[31] Writing Group and Edaravone (MCI-186) ALS 19 Study Group. “Safety and Efficacy of Edaravone in Well Defined Patients with Amyotrophic Lateral Sclerosis: A Randomised, Double-Blind, Placebo-Controlled Trial.” The Lancet Neurology, vol. 16, no. 7, 2017, pp. 505–12, https://doi.org/10.1016/S1474-4422(17)30115-1.

[32] “Muse Exosomes: Dezawa MuseExosomes Secretome Platform.” MuseCell Innovations, 2026, https://musecellinnovations.com/muse-exosomes. Accessed 7 Oct. 2026.

[33] Pluripotent without the Pain: How Dezawa MuseCells Dodge Tumor Formation. MuseCell Innovations, June 2026, https://musecellinnovations.com/articles/pluripotent-without-the-pain.pdf. Scientific brief. Date per the site’s Library page.

[34] “Muse Cell Research Hub: 120+ Studies.” MuseCell Innovations, 2026, https://musecellinnovations.com/research-hub. Accessed 7 Oct. 2026.

[35] “Celularity and MuseCell Innovations Announce U.S. Manufacturing Collaboration for the Dezawa MuseCell Platform.” MuseCell Innovations, 27 Aug. 2026, https://musecellinnovations.com/news/celularity-us-manufacturing-collaboration. Press release.

[36] Kuroda, Yasumasa, et al. “Endogenous Reparative Pluripotent Muse Cells with a Unique Immune Privilege System: Hint at a New Strategy for Controlling Acute and Chronic Inflammation.” Frontiers in Pharmacology, vol. 13, 2022, article 1027961, https://doi.org/10.3389/fphar.2022.1027961.

[37] Iseki, Masahiro, et al. “Human Muse Cells, Nontumorigenic Pluripotent-Like Stem Cells, Have Liver Regeneration Capacity through Specific Homing and Cell Replacement in a Mouse Model of Liver Fibrosis.” Cell Transplantation, vol. 26, no. 5, 2017, pp. 821–40, https://doi.org/10.3727/096368916X693662.

[38] Hori, Yusuke, et al. “Intravenous Administration of Human Muse Cells Recovers Blood Flow in a Mouse Model of Hindlimb Ischemia.” Frontiers in Cardiovascular Medicine, vol. 9, 2022, article 981088, https://doi.org/10.3389/fcvm.2022.981088.

[39] “製薬業界 きょうのニュースまとめ読み（2023年2月14日）” [Pharmaceutical Industry: Today’s News Roundup (February 14, 2023)]. AnswersNews, Quick, 14 Feb. 2023, https://answers.and-pro.jp/pharmanews/25031/.

[40] “「Muse細胞」用いた再生医療製品の開発中止 三菱ケミカルグループ” [Development of Regenerative Medicine Product Using Muse Cells Discontinued: Mitsubishi Chemical Group]. Nikkan Yakugyo, Jiho, 15 Feb. 2023, https://nk.jiho.jp/article/178340.

[41] “Muse Stem Cell Treatment: What to Expect.” MuseCell Innovations, 2026, https://musecellinnovations.com/muse-stem-cell-treatment. Accessed 7 Oct. 2026.

[42] The Role of Dezawa MuseCells in Orthopedics and Longevity: A Comprehensive Review. MuseCell Innovations, June 2026, https://musecellinnovations.com/articles/dezawa-musecells-orthopedics-longevity.pdf. White paper. Date per the site’s Library page.

[43] Minatoguchi, Shinya, et al. “Donor Muse Cell Treatment without HLA-Matching Tests and Immunosuppressant Treatment.” Stem Cells Translational Medicine, vol. 13, no. 6, 2024, pp. 532–45, https://doi.org/10.1093/stcltm/szae018.

[44] Khan, Adeel, and Ramiz Malik. “Multi-System Biological Age Reversal following MUSE Stem Cell Therapy: Case Reports.” Mathews Journal of Case Reports, vol. 10, no. 4, 2025, article 210, https://doi.org/10.30654/MJCR.10210.

[45] “A Confirmatory Study of CL2020 in Patients with ST-Elevation Myocardial Infarction.” Japan Primary Registries Network record jRCT1080224979, 2019. Epistemonikos, https://www.epistemonikos.org/en/documents/f9249d9433de25f8065af0b2b3bfbc96203ffff7.

[46] Gifu University Hospital. Institutional review board meeting record, 406th meeting, 13 Apr. 2020, https://www.hosp.gifu-u.ac.jp/origin/icc/file/R2.4IRBkiroku-2.pdf. In Japanese.

[47] “MuseCell Innovations Enters U.S. Market, Bringing Restorative Stem Cell Therapy Directly to American Patients.” MuseCell Innovations, 1 July 2026, https://musecellinnovations.com/news/musecell-innovations-enters-us-market. Press release.

[48] Gimeno, María Laura, et al. “A Pilot Phase IIa Randomized, Placebo-Controlled, Double-Blind Trial of Intravenous Human Pluripotent Adipose-Derived Stem Cells (PASCs) in Parkinson’s Disease: The REPOSE Study.” Cell Transplantation, vol. 35, 2026, article 9636897261492438, https://doi.org/10.1177/09636897261492438.

[49] Code of Federal Regulations. Title 21, section 1271.10, “Are My HCT/P’s Regulated Solely under Section 361 of the PHS Act and the Regulations in This Part, and If So What Must I Do?” eCFR, National Archives, https://www.ecfr.gov/current/title-21/chapter-I/subchapter-L/part-1271/subpart-A/section-1271.10. Accessed 7 Oct. 2026.

[50] Code of Federal Regulations. Title 21, section 1271.20, “If My HCT/P’s Do Not Meet the Criteria in § 1271.10, and I Do Not Qualify for Any of the Exceptions in § 1271.15, What Regulations Apply?” eCFR, National Archives, https://www.ecfr.gov/current/title-21/chapter-I/subchapter-L/part-1271/subpart-A/section-1271.20. Accessed 7 Oct. 2026.

[51] United States Code. Title 42, section 262, “Regulation of Biological Products” (Public Health Service Act, section 351). Legal Information Institute, Cornell Law School, https://www.law.cornell.edu/uscode/text/42/262. Accessed 7 Oct. 2026.

[52] “Public Safety Notification on Exosome Products.” U.S. Food and Drug Administration, 6 Dec. 2019, https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/public-safety-notification-exosome-products.

[53] “Important Patient and Consumer Information about Regenerative Medicine Therapies.” U.S. Food and Drug Administration, content current as of 8 Apr. 2024, https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/important-patient-and-consumer-information-about-regenerative-medicine-therapies.

[54] Code of Federal Regulations. Title 21, section 1271.3, “How Does FDA Define Important Terms in This Part?” Legal Information Institute, Cornell Law School, https://www.law.cornell.edu/cfr/text/21/1271.3. Accessed 8 Oct. 2026.

[55] U.S. Food and Drug Administration. Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use. Guidance for industry and FDA staff, July 2020, https://www.fda.gov/media/109176/download.

[56] U.S. Food and Drug Administration. Warning letter to Blue Horizon International, LLC, 26 May 2026, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/blue-horizon-international-llc-728085-05262026.

[57] U.S. Food and Drug Administration. Warning letter to R3 Medical Companies, 14 Aug. 2026, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/r3-medical-companies-726330-08142026.

[58] U.S. Food and Drug Administration. Warning letter to NexCell Scientific Inc., 11 Sept. 2026, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nexcell-scientific-inc-730612-09112026.

[59] “Approved Cellular and Gene Therapy Products.” U.S. Food and Drug Administration, content current as of 17 Sept. 2026, https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products.

[60] “Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes.” U.S. Food and Drug Administration, 22 July 2020, content current as of 9 Apr. 2024, https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/consumer-alert-regenerative-medicine-products-including-stem-cells-and-exosomes.

[61] “Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)” U.S. Food and Drug Administration, content current as of 11 Sept. 2024, https://www.fda.gov/cosmetics/cosmetics-laws-regulations/it-cosmetic-drug-or-both-or-it-soap.

[62] U.S. Food and Drug Administration. Warning letter to Kimera Labs, Inc., 1 Sept. 2023, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/kimera-labs-inc-649343-09012023.

[63] World Health Organization. “International Nonproprietary Names for Pharmaceutical Substances (INN): Proposed INN: List 127.” WHO Drug Information, vol. 36, no. 2, 2022, https://cdn.who.int/media/docs/default-source/international-nonproprietary-names-(inn)/pl127.pdf.

[64] “Questions and Answers regarding the End of the Compliance and Enforcement Policy for Certain Human Cells, Tissues, or Cellular or Tissue-Based Products (HCT/Ps).” U.S. Food and Drug Administration, content current as of 9 July 2021, https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/questions-and-answers-regarding-end-compliance-and-enforcement-policy-certain-human-cells-tissues-or.

[65] United States v. US Stem Cell Clinic, LLC. 998 F.3d 1302. United States Court of Appeals for the Eleventh Circuit, 2021. Read in summary: Food and Drug Law Institute, https://www.fdli.org/wp-content/uploads/2022/07/United-States-v.-US-Stem-Cell-Clinic-LLC.pdf.

[66] United States v. California Stem Cell Treatment Center, Inc. 117 F.4th 1213. United States Court of Appeals for the Ninth Circuit, 27 Sept. 2024. Read in summary: “Ninth Circuit Upholds FDA’s Authority to Regulate Stem Cell Clinic Treatments.” FDA Law Blog, Oct. 2024, https://www.thefdalawblog.com/2024/10/ninth-circuit-upholds-fdas-authority-to-regulate-stem-cell-clinic-treatments/. Reporter citation as given in the petition for certiorari, https://www.supremecourt.gov/DocketPDF/24/24-1189/359085/20250519120115741_CA%20Stem%20Cell%20Cert%20Petition.pdf.

[67] Supreme Court of the United States. Docket no. 24-1189, California Stem Cell Treatment Center, Inc. v. United States. Petition for a writ of certiorari denied 14 Oct. 2025, https://www.supremecourt.gov/search.aspx?filename=/docket/docketfiles/html/public/24-1189.html.

[68] Code of Federal Regulations. Title 21, section 1271.15, “Are There Any Exceptions from the Requirements of This Part?” Legal Information Institute, Cornell Law School, https://www.law.cornell.edu/cfr/text/21/1271.15. Accessed 8 Oct. 2026.

[69] U.S. Food and Drug Administration. Warning letter to Dynamic Stem Cell Therapy, 11 Feb. 2026, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dynamic-stem-cell-therapy-712579-02112026.

[70] U.S. Food and Drug Administration. Warning letter to Celularity, Inc., 1 Dec. 2025, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/celularity-inc-681480-12012025.

[71] Pike, Taylor, et al. “FDA Must Regulate Stem Cell Therapies to Mitigate Risks to Patients and the Public.” Proceedings of the National Academy of Sciences, vol. 123, no. 11, 2026, article e2508586123, https://doi.org/10.1073/pnas.2508586123.

[72] Werner, Michael J., and Sara M. Klock. “New Florida Law Attempts to Provide Leeway for Certain Stem Cell Treatments.” Holland & Knight, 18 Aug. 2025, https://www.hklaw.com/en/insights/publications/2025/08/new-florida-law-attempts-to-provide-leeway-for-certain-stem-cell.

[73] The Florida Senate, Committee on Health Policy. “Bill Analysis and Fiscal Impact Statement: SB 1768.” 31 Mar. 2025, https://www.flsenate.gov/Session/Bill/2025/1768/Analyses/2025s01768.pre.hp.PDF.

[74] U.S. Food and Drug Administration. Warning letter to Platinum Biologics LLC, 15 Aug. 2025, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/platinum-biologics-llc-705090-08152025.

[75] Florida Statutes. Section 458.3245, “Stem Cell Therapy.” 2025, https://www.flsenate.gov/Laws/Statutes/2025/458.3245. Section 459.0127 is the parallel provision for osteopathic physicians.

[76] Utah Code. Section 58-1-512, “Stem Cell Disclosure.” Effective 6 May 2026, https://le.utah.gov/xcode/Title58/Chapter1/C58-1-S512_2026050620260506.pdf.

[77] Texas Health and Safety Code. Chapter 1003, “Adult Stem Cells.” Texas Legislature Online, https://tcss.legis.texas.gov/resources/HS/pdf/HS.1003.pdf. Accessed 8 Oct. 2026.

[78] Tennessee General Assembly. House Bill 2246, 114th General Assembly, enacted as Public Chapter 1016, 2026. Legislative record at FastDemocracy, https://fastdemocracy.com/bill-search/tn/114/bills/TNB00060072/.

[79] “Rep. Chris Hurt Passes Bill to Establish Framework for Stem Cell Therapy in Tennessee.” Tennessee House Republican Caucus, Apr. 2026, https://tnhousegop.org/press-releases/2026/04/rep-chris-hurt-passes-bill-to-establish-framework-for-stem-cell-therapy-in-tennessee/. Press release.

[80] Georgia General Assembly. House Bill 1275, as passed, 2026. Office of the Governor, https://gov.georgia.gov/document/2026-signed-legislation/hb-1275/download.

[81] “Georgia and Tennessee Signal the Next Phase of State Stem Cell Therapy Laws.” Florida Healthcare Law Firm, 2026, https://floridahealthcarelawfirm.com/georgia-and-tennessee-signal-the-next-phase-of-state-stem-cell-therapy-laws/. The effective date is from LegiScan, https://legiscan.com/GA/text/HB1275/2025.

[82] The Florida Senate. “CS/CS/SB 1092: Podiatric Medicine.” 2026, https://www.flsenate.gov/Session/Bill/2026/1092. Enacted as chapter 2026-124, approved 11 June 2026.

[83] “Muse Cell Therapy: Find a Healthcare Center.” MuseCell Innovations, 2026, https://musecellinnovations.com/patients. Accessed 30 Oct. 2026.

[84] California Business and Professions Code. Section 684. Public.Law, https://california.public.law/codes/business_and_professions_code_section_684. Accessed 8 Oct. 2026.

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[86] California Health and Safety Code. Section 111550. Public.Law, https://california.public.law/codes/health_and_safety_code_section_111550. Accessed 8 Oct. 2026.

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