New Website - New Fraud? Wellbeing International Foundation Ltd Updates More Than Just Its Website.

 

Inside Wellbeing International Foundation’s “cell-free therapy”: claims vs. facts

Scope & method. On 3 Oct 2025, we reviewed Wellbeing International Foundation’s website and satellite pages, then cross-checked key assertions with regulators, consensus guidelines, and the scientific literature. Sources are cited inline.

What the New Website Promises

  • A “revolutionary” cell-free therapy derived from your own blood: draw 150 ml, extract and “stress” cells to release “massive quantities of exosomes and healing signals,” yielding ~10 treatments. The site says this removes risks of traditional stem-cell therapy, “can cross the blood–brain barrier,” and that animal studies show healing is accelerated “by up to 30%.” It also lists serious conditions (Parkinson’s, MS), sports injuries, “longevity,” and showcases NFL names in testimonials. Locations span dozens of US and EU cities; the footer address is Williams House, 20 Reid St, Hamilton HM11, Bermuda. Wellbeing International+4Wellbeing International+4Wellbeing International+4

What we could verify (and what we couldn’t)

1) Regulatory status

  • United States (FDA): The FDA states plainly: there are no FDA-approved exosome products. Clinics marketing exosome infusions are flagged as selling unapproved biologics unless under an IND-governed clinical trial. The agency has issued warnings and consumer alerts. The Wellbeing site lists US cities but cites no INDs, trial IDs, or approvals. U.S. Food and Drug Administration+2U.S. Food and Drug Administration+2

  • UK/EU context: In the UK, injectable exosomes are treated as medicinal products requiring MHRA authorisation; reporting this year highlighted enforcement against human-derived exosome use in cosmetics/aesthetics. Again, no UK authorisation numbers or clinical-trial references appear on Wellbeing’s site. path.cam.ac.uk+1

Bottom line: Marketing systemic exosome infusions as treatment outside formal trials is at odds with current regulator guidance in both the US and UK. The site provides no authorisation or trial identifiers to show it operates within those frameworks. U.S. Food and Drug Administration+2U.S. Food and Drug Administration+2

2) “Crosses the blood–brain barrier”

  • There is growing preclinical evidence EVs/exosomes can traverse the BBB (mostly animal models and mechanistic reviews). That does not equate to clinically proven, approved therapies for Parkinson’s, MS, stroke, etc. The website presents the BBB claim as a clinical advantage without clinical data. BioMed Central+1

3) “Up to 30% faster healing” (animal studies)

  • The site states animal studies show “up to 30%” faster healing but cites nothing. Meta-analyses in wound models do suggest benefit from MSC-exosomes, but effect sizes vary widely and aren’t reported as a universal “30%” speed-up. We couldn’t locate a peer-reviewed source that substantiates that specific figure across indications. Wellbeing International+1

4) Safety claims (“no risk of immune rejection” and “removes risks”)

  • Using one’s own cells may reduce immunogenicity, but “no risk” is absolute and unsupported—EV products have manufacturing, purity, and contamination risks; FDA alerts include adverse events with unapproved exosome products. U.S. Food and Drug Administration+1

5) Manufacturing, quality & reproducibility

  • The site says it “stresses” cells to release “massive quantities” of exosomes, but provides no detail on GMP manufacturing, batch release criteria, EV characterization, or compliance with MISEV (the field’s minimal information standards). Consensus guidelines emphasise rigorous EV definition/QA; the site lists none. isevjournals.onlinelibrary.wiley.com+1

6) Evidence base for serious diseases

  • The “About” page implies mitigation of degenerative effects in Parkinson’s and MS, but supplies no clinical trial data (registrations, endpoints, adverse events, peer-reviewed outcomes). A search of ClinicalTrials.gov shows EV/exosome trials exist generally, but none tied to “Wellbeing International Foundation” or the specific process described. Wellbeing International+1

7) Testimonials & celebrity association

  • Named testimonials (e.g., Jameis Winston, Doug Baldwin, Jimmy Graham, Garrett McNamara) are presented, but there is no independent corroboration, clinical context, or disclosures (e.g., compensation). Testimonials are not evidence of safety/efficacy and can mislead when used in lieu of data. Wellbeing International

8) Corporate transparency

  • The brand presents as a “Foundation Ltd” with a Bermuda address. “Foundation” may imply a charity, but “Ltd” denotes a company; the site provides no corporate registration number, directors’ filings, or jurisdictional regulatory licences for providing medical treatments in each listed country. Wellbeing International

What a credible clinic would show (that this site doesn’t)

  • Trial IDs/INDs and regulatory approvals for each jurisdiction of operation. U.S. Food and Drug Administration

  • Detailed protocols: EV source, isolation, characterization (markers, size distribution), sterility, potency assays, batch variability, and GMP facility credentials aligned with MISEV and regulator expectations. isevjournals.onlinelibrary.wiley.com

  • Peer-reviewed clinical outcomes (not testimonials): endpoints, control groups, adverse events, and follow-up in target diseases (e.g., MS, Parkinson’s).

  • Risk disclosures consistent with FDA/MHRA guidance for unapproved biologics. U.S. Food and Drug Administration

Red flags & open questions

  1. Unapproved therapy marketed across multiple countries with no stated approvals or trial governance. Which INDs/authorisations cover the US/EU locations they list? Wellbeing International

  2. Absolute safety language (“no risk of immune rejection”) and unreferenced efficacy numbers (“30% faster healing”). Where are the citations? Wellbeing International

  3. Serious-disease claims (Parkinson’s/MS) made without human clinical data. What peer-reviewed trials support these indications for their specific product/process? Wellbeing International

  4. Manufacturing opacity: Who is the manufacturer? Is production GMP-certified? How are EVs characterised and released? (MISEV/QA alignment). isevjournals.onlinelibrary.wiley.com

  5. Celebrity testimonials used in place of data; any financial relationships or conflicts disclosed? Wellbeing International

Verdict (for now)

  • Scientific plausibility: Extracellular vesicles are a hot, promising research area; EVs can cross the BBB in models and may promote repair in animals. That does not equal a proven, authorised clinical treatment for the diseases Wellbeing lists. BioMed Central+1

  • Regulatory compliance: Current regulator positions are clear: no FDA-approved exosome products; UK authorities treat injectable EVs as medicinal products requiring authorisation. The website shows no approvals, no trial IDs, and no QA detail—a major gap. U.S. Food and Drug Administration+1

  • Marketing vs. medicine: The site relies on sweeping claims and testimonials rather than transparent data. Until the company provides trial evidence, authorisations, and manufacturing/QA details, its medical promises warrant strong scepticism.

Sources (selected)

Website pages: home, about, testimonials, “further info.” Wellbeing International+3Wellbeing International+3Wellbeing International+3
Regulators & consensus: FDA consumer alerts; ISEV/MISEV 2018/2023; UK reporting on exosome legality. path.cam.ac.uk+4U.S. Food and Drug Administration+4U.S. Food and Drug Administration+4
Scientific reviews on BBB & EVs: 2022–2025 reviews/meta-analyses. BioMed Central+2PMC+2

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