Atlas›Domain XII · Complementary, energy & biofield›Guide 147
Guide XII-147

Unapproved stem-cell and exosome clinics

A 27 · L 62 · M 1114 interventions in the Trinity explorer
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[source: …] where a claim comes from[uncertain] not confirmed in a primary source[synthesis] the writer's reconstruction

1. Introduction

Version followed: there is no founder, manual or single originating organisation. The method is described as regulators publish it (US FDA consumer alerts and enforcement statements, CDC MMWR, Health Canada, UK MHRA guidance, Australian TGA changes as reported by the University of Melbourne), with patient-facing guidance from the International Society for Stem Cell Research (ISSCR Patient Handbook on Stem Cell Therapies, 2008, Appendix I of its Guidelines for the Clinical Translation of Stem Cells). This guide sets out the psychotherapist's own work alongside the method: the psychotherapist never performs, sells, prescribes or recommends these products or procedures. Sections 4 and 5 are the psychotherapist's own work alongside a client who is considering, using or recovering from them.

What it is. For-profit clinics, in the client's own country or abroad ("stem-cell tourism"), sell injections or infusions described as "stem cells", "regenerative medicine" or "exosomes" for conditions where no such product is approved. Products named by regulators include stromal vascular fraction (SVF) and other "adipose-derived stem cells" taken from the patient's own fat, bone marrow aspirate concentrate (BMAC), and donor birth-tissue products (umbilical cord blood, Wharton's jelly, amniotic fluid). Exosomes are small vesicles released by cells; clinics market exosome products as carrying regenerative signals. [source: FDA consumer alert; Health Canada 2019]

Core idea as the clinics present it (attributed). Injected cells or cell-derived vesicles are said to home to damaged tissue and repair, regenerate or "reset" it, so that one product can help many unrelated conditions. The FDA lists the uses being promoted without approval: orthopaedic conditions and pain, multiple sclerosis, ALS, Alzheimer's, Parkinson's, stroke, epilepsy, heart and lung disease, COVID-19, autism, macular degeneration and blindness, chronic pain and fatigue. A US survey (Turner and Knoepfler, Cell Stem Cell, 2016) found at least 351 businesses operating 570 clinics, some advertising for 30 or 40 conditions, including nine promoting treatment for autism and nine for cerebral palsy to parents. [source: FDA consumer alert; KFF Health News report on Turner and Knoepfler 2016]

What a client typically experiences. The client usually finds the clinic online or through testimonials. A consultation follows, then either tissue harvesting from the client's own body (fat or bone marrow) or use of a purchased donor product, then injection in an outpatient setting (orthopaedic, pain, chiropractic or spine clinics, ambulatory surgery centres; in reported cases into joints, the spine, the eyes or a vein). Payment is out of pocket: in the Florida eye case each patient paid US$5,000; a family travelling to Beijing for an autistic child reported spending £20,000 on a one-month course. Clinics abroad may involve weeks of repeated procedures. [source: CDC MMWR 2018; HCPLive report on Kuriyan et al., NEJM; LaingBuisson IMTJ 2013]

Who practises it. Physicians, nurse practitioners and other clinic staff; the CDC series included chiropractic and pain clinics. FDA notes that FDA registration of a manufacturer or distributor is not FDA approval. [source: CDC MMWR 2018]

Regulation in the main jurisdictions (one line each).

  • United States: stem-cell and exosome products are regulated as drugs and biologics and generally need FDA approval; the only approved stem-cell products are cord-blood haematopoietic progenitor cells for blood-production disorders; "there are currently no FDA-approved exosome products"; FDA's enforcement-discretion period for certain HCT/Ps ended 31 May 2021; a narrow exemption ("361 HCT/P", minimally regulated tissue for same-function use) does not cover clinics' typical products, as courts confirmed (see Harm account). [source: FDA consumer alert; FDA 2019 exosome alert; Hogan Lovells 2021]
  • Canada: cell therapies are drugs under the Food and Drugs Act; most are experimental and lawful only inside a Health Canada-authorised clinical trial; using a patient's own cells (BMAC, SVF) does not make a treatment proven. [source: Health Canada 2019]
  • United Kingdom: cell therapies are advanced therapy medicinal products (ATMPs) needing an MHRA marketing authorisation or a clinical-trial authorisation; narrow unlicensed routes exist (hospital exemption, specials) and still require a manufacturer's licence; the Human Tissue Authority licenses the donation, procurement and testing of tissues and cells; in 2020 the ISSCR asked the MHRA to step up enforcement against a "surge of clinics and providers marketing unproven therapies". [source: GOV.UK ATMP guidance; ISSCR 2020]
  • Australia: from 1 July 2019 the TGA's oversight extended to stem-cell products made from a patient's own cells when supplied outside hospitals, with possible criminal penalties for continued supply; products from a patient's own cells given by a doctor or dentist in a hospital remain excluded. [source: University of Melbourne 2019]
  • Elsewhere: clinics in parts of Asia, Eastern Europe and Latin America have marketed stem-cell treatments to international patients; home regulators do not oversee treatment abroad. [source: LaingBuisson IMTJ 2013; FDA 2019 exosome alert]

Evidence status (one line). Outside established haematopoietic (blood and immune reconstitution) uses and authorised trials, safety and effectiveness have not been established, and regulators and the CDC report serious harms. [source: CDC MMWR 2018; FDA consumer alert]

2. Framework

There is no therapeutic protocol to follow. The framework below has two strands: the clinic pathway the client may be on (to orient the therapist), and the psychotherapist's own phases of work alongside it. [synthesis, built on the sources cited]

A. The clinic pathway as clients meet it [source: CDC MMWR 2018; HCPLive/NEJM; ISSCR Handbook 2008; FDA 2019 exosome alert]

  1. Discovery: web search, social media, testimonials, word of mouth, patient groups.
  2. Consultation and sales: claims across many conditions, "your own cells", "natural", "no risk"; a price quoted; sometimes the word "trial" or "study" used for a paid service.
  3. Harvest or product sourcing, then injection or infusion, often as an outpatient, sometimes on a trip abroad.
  4. Aftermath: improvement, no change, or complications (infection, vision loss, growths), and often further paid rounds.

B. The psychotherapist's phases [synthesis]

  1. Inquiry and recording (any session; routine). Goal: the client feels safe to disclose. Move on when the plan, timing, cost and medical involvement are known.
  2. Exploration of meaning (can be woven into ongoing therapy). Goal: understand hopes, fears, explanatory model and pressures. Move on when the client can name what they hope for and what they would count as success.
  3. Informed, values-based decision support (within ongoing therapy). Goal: the client can weigh the decision using the ISSCR question set and the regulator's own information, and has a second medical opinion. Move on when the client has made a decision and knows what they will do if something goes wrong.
  4. Coordination (with consent, at any point). Goal: the treating doctor or pharmacist knows the plan. Move on once contact is made or the client has declined it, with the refusal recorded.
  5. Risk response and reporting (at any point; overrides other phases). Goal: urgent medical care for complications; safeguarding for children or adults at risk; reports to regulators.
  6. Aftermath work (variable length). Goal: help with grief, regret, anger, financial loss, adjustment to disability, or living with uncertainty.

Format. Usually within ongoing individual therapy; family sessions where a child or dependent adult is the intended recipient, or where the family is split over the decision. [synthesis]

3. Guiding principles

  • Ask without judgement. Clients hide what they expect to be criticised for; a neutral question gets the real plan. [synthesis]
  • Autonomy for adults with capacity. The decision is the client's; the therapist's job is a clearer decision, not a particular one. [synthesis]
  • Never perform, sell, prescribe or recommend. Do not endorse a clinic, product or trial, and do not take referral fees or commissions. [synthesis]
  • Stay in scope. Medical questions (eligibility, risks of a specific procedure, interactions with current treatment) go to the client's doctor; the therapist states regulators' published positions only, with the source. [synthesis]
  • Hope is legitimate; exploited hope is the risk. Respect the wish to recover while naming how marketing works. [synthesis, consistent with ISSCR Handbook on testimonials]
  • A paid service is not a trial. In legitimate trials participants generally do not pay for the treatment, and an ethics committee and a regulator oversee it; keep this distinction in view. [source: ISSCR Handbook 2008; FDA 2019 exosome alert]
  • "Your own cells" does not mean proven or safe. Health Canada and the ISSCR both say this directly. [source: Health Canada 2019; ISSCR Handbook 2008]
  • Children and adults lacking capacity are a safeguarding matter as well as a family choice. Hold consent, assent and safeguarding duties together. [synthesis]
  • Coordinate, do not triangulate. With consent, bring the medical team in rather than arbitrating medical claims yourself. [synthesis]
  • Report harm. Adverse events and illegal marketing have reporting routes; help the client use them. [source: FDA consumer alert; Health Canada 2019]
  • Document neutrally. Record what the client plans or has received, what was discussed, and any consent to contact others, without pejorative language. [synthesis]
  • Manage your own reactions and conflicts of interest. Strong views for or against can leak into the session; supervision helps. Professional ethics codes on conflicts of interest and avoiding harm apply [synthesis; specific code provisions not cited: uncertain].

4. Intervention inventory

All interventions below are the psychotherapist's own work. None involves performing, arranging, recommending or discouraging a specific procedure on medical grounds; medical judgement stays with the client's doctors. Steps are [synthesis] unless a source is given.

4.1 Routine, non-judgemental inquiry and recording

  • Purpose / when: At intake and periodically, especially with clients who have chronic pain, joint disease, neurological or degenerative illness, sight loss, long COVID or fatigue, or a child with autism or cerebral palsy: the conditions clinics target. [source for target conditions: FDA consumer alert; Turner and Knoepfler 2016 via KFF]
  • Steps: (1) Normalise: many people look into treatments outside standard care. (2) Ask open questions about anything tried, planned or researched, including injections, infusions and treatments abroad. (3) Ask what product, where, by whom, at what cost, and whether their doctor knows. (4) Record it factually in the notes, with the client's own words for the product. (5) Ask permission to return to it later.
  • Example language (illustrative): "A lot of people with long-term pain look into newer treatments, including stem-cell or regenerative injections. Have you looked into anything like that, or had anything done?" / "I'm not asking to judge it. It helps me understand what you're hoping for and what's going on in your life."
  • Watch for: Embarrassment or defensiveness (slow down, restate neutrality); a planned date or deposit already paid (move to 4.4 and 4.6 sooner); treatment of a child (4.10). Working: the client tells you the details freely and returns to the topic unprompted.

4.2 Exploring meaning, hopes, expectations and explanatory model

  • Purpose / when: Once a plan or past treatment is known. Understand what draws the client: hope of recovery, control, distrust of medicine after poor care, identity ("I don't give up"), community and online groups, or exhaustion with slow standard care. [synthesis]
  • Steps: (1) Ask what the client understands the cells or exosomes will do in their body (their explanatory model, in their words). (2) Ask what result they expect and by when. (3) Ask what it would mean if it worked, and if it did not. (4) Ask what the decision means for their relationships and finances. (5) Reflect hopes and fears back without correcting the model.
  • Example language (illustrative): "In your own words, how do you understand these cells helping?" / "If six months from now nothing had changed, what would that be like for you?" / "What has it been like dealing with your usual doctors about this?"
  • Watch for: Hopes that carry very high stakes ("it's my last chance"); a model built entirely from the clinic's material; grief about the illness under the hope. Working: the client can hold both hope and uncertainty in the same conversation.

4.3 Exploring how the offer reached the client (marketing literacy)

  • Purpose / when: When the client relies on testimonials, websites or a salesperson. The ISSCR Handbook names warning signs: testimonials offered as proof, one cell type for many unrelated diseases, unclear cell source or method, claims of no risk, and high or hidden costs. [source: ISSCR Handbook 2008]
  • Steps: (1) Ask the client to show or describe the material that persuaded them. (2) Together, notice what kind of evidence it is (stories, before-and-after claims, a list of many conditions, a price). (3) Name the ISSCR warning signs as published information, not your opinion. (4) Ask what the client makes of them. (5) Leave the conclusion with the client.
  • Example language (illustrative): "The international stem-cell research society publishes some warning signs for patients. Would it be useful to look at them together against what the clinic has told you?" / "What strikes you when you see that the same treatment is offered for arthritis, autism and Parkinson's?"
  • Watch for: Feeling attacked (return to 4.2); the word "trial" used for a paid service (see 4.5). Working: the client starts asking their own questions of the clinic.

4.4 Informed, values-based decision support using the ISSCR question set

  • Purpose / when: Before any commitment, or when a client feels pushed. The ISSCR Handbook gives patients question groups to put to any provider: about the treatment and alternatives; evidence and oversight; safety and emergencies; patient rights; costs; and second opinions. [source: ISSCR Handbook 2008; questions paraphrased]
  • Steps: (1) Offer the handbook (or the ISSCR guide page) as a resource the client may read; do not hand over a clinic list. (2) Help the client turn the question groups into their own written list, for example: Is this routine care or a formal trial? What published evidence supports it for my condition? Which regulator has approved it for this disease? Who is the independent ethics committee? What are the immediate and long-term risks? Who provides emergency care, and who pays, especially abroad? What follow-up is planned? Does the consent form waive the provider's liability? Could this affect eligibility for other trials? (3) Help the client clarify their values: what matters most (function, time, money, family, safety). (4) Encourage an independent medical second opinion, giving the reviewer the protocol and consent documents, as the handbook advises. (5) Agree a review point before any payment date.
  • Example language (illustrative): "Would it help to write out the questions you want the clinic to answer in writing before you decide?" / "Whatever you decide, what matters most to you here?" / "The handbook suggests taking the paperwork to an independent doctor. Is that something you'd want to do?"
  • Watch for: Pressure to pay quickly, discounts that expire, or clinic refusal to give documents (these are themselves information for the client); the therapist drifting into persuading. Working: the client gets written answers, or notices that they cannot.

4.5 Checking regulatory status together (client-led)

  • Purpose / when: When the client says a product is "approved", "registered" or "part of a study". [source: FDA 2019 exosome alert; Health Canada 2019; CDC MMWR 2018]
  • Steps: (1) Explain the distinction regulators draw: FDA registration of a firm is not approval; a legitimate US investigational use has an FDA-issued IND number and an Institutional Review Board named on the consent form; in Canada, the client can check Health Canada's Drug Product Database and Clinical Trials Database; in the UK, an ATMP needs MHRA authorisation or a trial authorisation. (2) Suggest the client ask the clinic for the IND number and FDA acknowledgement, or local equivalent, and confirm it with their own doctor, as FDA advises. (3) Note that FDA does not oversee treatment abroad. (4) The client does the checking; the therapist does not certify any clinic.
  • Example language (illustrative): "The FDA suggests asking the clinic for its IND number and checking it with your own doctor. Would you be willing to ask them for that?" / "'Registered' and 'approved' sound similar but mean different things to the regulator."
  • Watch for: The therapist being drawn into judging legality of a specific clinic (refer to the regulator or the client's doctor). Working: the client has a factual answer from an authoritative source.

4.6 Coordination with the client's doctor or pharmacist

  • Purpose / when: As soon as a procedure is planned or has happened, especially if the client has a serious illness, is on immunosuppressants or anticoagulants, or has had symptoms since treatment. [synthesis]
  • Steps: (1) Ask whether the doctor knows. (2) Explore fears of being judged or dropped by the doctor. (3) Offer options: the client tells the doctor; you help them prepare what to say; or, with written consent, you contact the doctor yourself to share that a procedure is planned or has occurred. (4) Never advise on stopping, starting or changing medicines; route those questions to the prescriber or pharmacist. (5) Record consent and what was shared.
  • Example language (illustrative): "Your doctor will be better able to look after you if they know about the injections. What makes it hard to tell them?" / "Would you like to practise how you'd raise it at your next appointment?"
  • Watch for: Plans to stop standard treatment in favour of the procedure (risk: 4.9); refusal of consent (respect it, record it, revisit later). Working: the medical team is informed and the client feels less alone with the decision.

4.7 Financial pressure and exploitation

  • Purpose / when: When costs are large, involve debt, loans, crowdfunding or family savings, or when repeat rounds are sold. Reported out-of-pocket costs include US$5,000 per patient (Florida) and £20,000 for one family's month abroad. [source: HCPLive/NEJM; LaingBuisson IMTJ 2013]
  • Steps: (1) Ask about total costs including travel, accommodation and emergency care, which the ISSCR advises checking against insurance coverage. (2) Explore who else is affected and who is pressing for the decision. (3) Ask about refund terms and what happens if more rounds are proposed. (4) Support the client to set their own limit in advance. (5) If an older or vulnerable adult is being pressured by others to pay, consider adult safeguarding. [source for cost questions: ISSCR Handbook 2008; rest synthesis]
  • Example language (illustrative): "Before deciding, would it help to add up the whole cost, including what happens if something goes wrong abroad?" / "If they suggest another round afterwards, what's your limit?"
  • Watch for: Shame about money already spent; sunk-cost reasoning; a clinic or group member acting as fundraiser. Working: the client makes the financial decision deliberately rather than under pressure.

4.8 Clients planning treatment abroad ("stem-cell tourism")

  • Purpose / when: When the client plans to travel. FDA notes it does not oversee treatment in other countries and advises learning the destination's rules and being cautious; the ISSCR advises checking emergency-care costs and insurance cover abroad. [source: FDA 2019 exosome alert; ISSCR Handbook 2008]
  • Steps: (1) Explore the plan: destination, length of stay, who travels with them. (2) Ask what happens if they become unwell there or after returning, and who at home will provide follow-up. (3) Encourage them to tell their home doctor before going and to bring back all records of what was given. (4) Plan emotional support for the trip and the return, including a session soon after. [steps 1-4 synthesis]
  • Example language (illustrative): "If you got a fever or a change in your eyesight after you got home, who would you call?" / "Could we book a session for the week you get back?"
  • Watch for: Isolation abroad, pressure to extend treatment on site, lack of records. Working: a follow-up plan exists before departure.

4.9 Recognising and responding to risk

  • Purpose / when: Throughout. Risks named in sources: delay of legitimate treatment (FDA), serious infections including bloodstream, joint and spinal infections and epidural abscess (CDC), vision loss after eye injections (NEJM report), abnormal growths after injected cells (NEJM report), and reports worldwide of strokes, cardiac arrest, cancers and death (University of Melbourne summary). [source: FDA 2019 exosome alert; CDC MMWR 2018; HCPLive/NEJM; ipscell.com on Berkowitz et al.; University of Melbourne 2019]
  • Steps: (1) If the client is considering stopping or delaying standard treatment, explore it openly and, with consent, bring in their doctor (4.6). (2) After any procedure, ask about new symptoms: fever, worsening joint or back pain, redness at an injection site, new weakness or numbness, or any change in vision. (3) If any such symptom is reported, advise prompt medical assessment the same day and help the client act on it; do not interpret the symptom. (4) Screen for despair or suicidal thinking if the procedure has failed or caused harm, following standard risk assessment. (5) Watch for adults at risk (cognitive impairment, dementia, serious illness) being taken for treatment by others: consider capacity and adult safeguarding. [steps synthesis]
  • Example language (illustrative): "Since the injection, have you noticed any fever, new pain, or anything different with your eyes?" / "That needs a doctor today. Can we work out now who you'll call?"
  • Watch for: Minimising symptoms to avoid admitting the procedure to doctors; clinics advising clients to wait it out [synthesis]. Working: symptoms are assessed quickly and the client's doctors know what was given.

4.10 Children and dependent adults: consent, assent and safeguarding

  • Purpose / when: When a parent or carer is considering treatment for a child (clinics have promoted treatment for autism and cerebral palsy to parents; FDA lists autism among unapproved uses) or for an adult who lacks capacity. [source: KFF on Turner and Knoepfler 2016; FDA consumer alert]
  • Steps: (1) Explore the parent's hopes, exhaustion and pressures with the same respect as 4.2. (2) Ask about the child's own experience and, as far as their development allows, their views (assent): a family account from Beijing described the child's repeated injections and drips as distressing. [source: LaingBuisson IMTJ 2013] (3) Ask whether the child's paediatrician knows, and encourage the ISSCR questions (4.4) and a second opinion. (4) Know your local threshold for safeguarding referral: concern that a child is likely to suffer significant harm from an unapproved procedure, or is being deprived of necessary medical care, is discussed with your safeguarding lead and the child's doctor and referred according to local procedure [synthesis; thresholds and routes vary by jurisdiction: follow local safeguarding procedure]. (5) Never name the child in correspondence beyond what the referral requires. For adults lacking capacity, apply your jurisdiction's capacity and best-interests law [synthesis].
  • Example language (illustrative): "You've been fighting hard for your child. What are you hoping this will change for them?" / "How does your child cope with procedures and travel? How might they experience this?" / "Has their paediatrician had a chance to look at the clinic's paperwork?"
  • Watch for: Parents splitting over the decision; siblings affected by costs; signs of harm after treatment. Working: decisions include the child's doctor and the child's own experience.

4.11 Health anxiety, somatic symptoms and chronic illness

  • Purpose / when: When the search for a cure is driven by health anxiety, persistent somatic symptoms, chronic pain or grief over progressive illness. Use established psychological approaches (CBT for health anxiety, acceptance-based work for chronic pain, adjustment and grief work) as covered in Domain II. [synthesis; cross-reference Domain II]
  • Steps: (1) Separate the decision about the procedure from the underlying distress. (2) Formulate the cycle of searching, hope and disappointment. (3) Offer evidence-based psychological help for the distress itself, alongside, not instead of, medical care. (4) Help the client define goals that do not depend on a cure.
  • Example language (illustrative): "It sounds like each new treatment brings a surge of hope and then a crash. Could we look at that pattern together?"
  • Watch for: The therapy being experienced as a rival treatment or as dismissal of the illness. Working: distress falls even while the medical situation is unchanged.

4.12 Aftermath: grief, regret, anger and adjustment after harm or no benefit

  • Purpose / when: After treatment that did not help, or that caused injury (for example sight loss or a serious infection). [synthesis]
  • Steps: (1) Let the client tell the story at their own pace. (2) Name and normalise shame and self-blame; place responsibility where the sources do (illegal marketing and unsafe products). (3) Work with grief for lost function and lost money. (4) Address family conflict and blame. (5) Coordinate with rehabilitation services (for example low-vision services) via the medical team. (6) Offer help with reporting (4.13) and, if the client wishes, with seeking legal advice.
  • Example language (illustrative): "You made the best decision you could with what you were told. The people selling it knew more than you did." / "What would help you most right now: practical steps, or space to be angry about it?"
  • Watch for: Depression, suicidal thinking, trauma symptoms after a frightening complication, and further purchases to repair the first. Working: the client can talk about it without collapse and is re-engaged with care.

4.13 Reporting routes

  • Purpose / when: After an adverse event, or when illegal marketing is encountered. [source: FDA consumer alert; FDA 2019 exosome alert; Health Canada 2019; GOV.UK ATMP guidance]
  • Steps: (1) United States: adverse events to FDA MedWatch (online or by phone, as FDA states); product questions to FDA's biologics consumer line. (2) Canada: adverse reactions to Health Canada by its toll-free line or online; non-compliant sale or advertising through Health Canada's complaint form. (3) United Kingdom: unlicensed medicines and suspected side effects to the MHRA (Yellow Card scheme, which takes reports from patients, the public and professionals on suspected side effects to medicines and on falsified products [source: MHRA Yellow Card guidance]; its use for unlicensed cell products specifically [uncertain]); tissue-establishment concerns to the Human Tissue Authority [uncertain: complaint route not verified]. (4) Australia: the TGA [uncertain: reporting route not verified]. (5) Professional boards for the prescribing clinicians; consumer and advertising regulators for misleading claims [uncertain: specific bodies not verified]. (6) Safeguarding services for children and adults at risk. Help the client report; report yourself where your professional duties require it.
  • Example language (illustrative): "The regulator collects reports like yours to protect other patients. Would you like help filling one in?"
  • Watch for: Fear of retaliation or of losing a refund; confidentiality limits when you report. Working: a report is made, or the client has made an informed choice not to.

4.14 Documentation and managing your own position

  • Purpose / when: Always. [synthesis]
  • Steps: (1) Record products, dates, providers, costs, symptoms, consents and referrals factually. (2) Do not sell, recommend or accept fees connected with any clinic or product. (3) Take strong personal reactions (contempt, rescue, alarm) to supervision. (4) Keep a short list of authoritative public resources (FDA, Health Canada, MHRA, TGA, ISSCR) rather than a list of clinics.
  • Example language (illustrative): "I don't recommend or sell any treatments; my part is helping you think it through and stay safe."
  • Watch for: Being asked to endorse a clinic or write a supporting letter: decline and explain your role. Working: the client experiences you as neutral and reliable.

5. Handling problems

The sources address patient risk and regulation, not therapy process. Everything in this section is [synthesis] unless a source is given.

  • The client is determined to go ahead. Respect the adult client's decision. Shift to harm reduction: written answers to the ISSCR questions, an informed home doctor, records of what is given, a symptom plan (4.9), a financial limit (4.7) and a session booked afterwards. Say plainly that you will still be there whatever happens.
  • The client hides the plan, or discloses only afterwards. Thank them for telling you; avoid "why didn't you say". Ask what made it hard to raise and what would make it easier next time. Move straight to symptom check (4.9) and coordination (4.6).
  • The client asks what you think, or asks you to recommend or endorse a clinic. Explain your role: you do not recommend or discourage specific medical procedures; you can share what regulators publish (with the source) and help them think. Decline any request for a supporting letter for a clinic, fundraising or insurer.
  • Rupture: the client feels you are against them. Acknowledge it directly; name the hope you share (that they feel better); return to their goals and values (4.2). Check whether your own views leaked into tone or questions, and take it to supervision.
  • Overwhelm with information or with illness. Slow down; narrow to one question ("what do you need to know before deciding?"); use grounding and pacing; postpone the decision work if the client is in crisis.
  • Family conflict. Offer a joint session with the client's consent; let each person say what they fear and hope; keep the decision with the person who holds it (the adult client, or those with parental responsibility for a child, within safeguarding limits). Watch for financial coercion of older relatives (4.7).
  • Online communities or patient groups pressing for treatment. Explore what the group gives (belonging, hope, information) and the cost of disagreeing with it. Help the client hold their own pace without forcing them to leave.
  • The client is seriously or terminally ill. With consent, link with the treating team and, where relevant, palliative care, so that the procedure is not the only source of hope or support. Avoid presenting any route as a treatment for the disease.
  • Harm has occurred and the client is angry with you for not stopping them. Hear it without defending; acknowledge the limits of your role and their pain; focus on present needs (medical care, reporting, support).
  • Non-adherence to medical follow-up after a complication. Explore shame and avoidance; break the next step down; offer to help them prepare or, with consent, to contact the clinician.
  • A colleague refers clients to clinics or sells products. Raise it with the colleague and through your service's governance; consider your professional body's guidance on conflicts of interest and harm [synthesis; specific code provisions not cited: uncertain].
  • Risk flags inside this section (see Harm account): any new symptoms after an injection (fever, pain, weakness, sight change) need same-day medical assessment; a child or dependent adult facing an unapproved procedure is a safeguarding consideration.

Harm account

What was actually done

  • Eye injections, Florida (2015). Three women aged 72, 78 and 88 with non-neovascular ("dry") age-related macular degeneration found a private clinic through an online search and each paid US$5,000. Fat was taken from their abdomens, processed into a product described as stem cells, mixed with their blood and injected into the vitreous of both eyes on the same day. The company said they were not treated as part of a clinical trial. A lawsuit reportedly said a nurse practitioner performed the injection. Reported by Kuriyan and colleagues in the New England Journal of Medicine as "Vision Loss after Intravitreal Injection of Autologous 'Stem Cells' for AMD" [uncertain: year and citation details from secondary reports only]. [source: HCPLive report]
  • Contaminated umbilical-cord-blood products (2018). Products processed by Genetech, Inc. and distributed by Liveyon, LLC, neither FDA-approved nor lawfully marketed, were injected mainly into joints and the spine (one patient also by infusion) in orthopaedic, pain, chiropractic and spine clinics and an ambulatory surgery centre, for pain, osteoarthritis, rotator-cuff tears, back pain and rheumatoid arthritis. Liveyon issued a voluntary recall on 28 September 2018. [source: CDC MMWR, Perkins et al., 21 December 2018]
  • US Stem Cell Clinic (Florida). The US Department of Justice, for FDA, sued US Stem Cell Clinic LLC (Weston, FL), US Stem Cell Inc. (Sunrise, FL) and chief scientific officer Kristin Comella in May 2018 over stromal vascular fraction products made from patients' fat. On 3 June 2019 the US District Court for the Southern District of Florida found the products adulterated and misbranded; on 25 June 2019 it barred the defendants from making or distributing SVF products until they comply with the law. In June 2021 the Eleventh Circuit upheld the ruling, holding that neither the "same surgical procedure" exception nor the "361 HCT/P" exception applied. Whether this clinic was the one in the Florida eye report is not established in the sources here [uncertain]. [source: FDA statement 25 June 2019; Hogan Lovells 2021]
  • Exosome products (2019). FDA reported that clinics already selling illegal "stem cell" products had begun offering exosome products with claims to prevent, treat or cure diseases, and that it had received multiple reports of serious adverse events in Nebraska patients given unapproved products marketed as containing exosomes (details not given in the alert). [source: FDA public safety alert, December 2019]
  • Stem-cell tourism and a spinal growth. A man received injections of mixtures described as embryonic, fetal neural and mesenchymal stem cells at clinics outside the US (reports mention Russia and Mexico), apparently without immunosuppression; a mass later filled his lower spinal column and was genetically distinct from him, pointing to the transplanted cells. Reported by Berkowitz and colleagues in the New England Journal of Medicine, "Glioproliferative Lesion of the Spinal Cord as a Complication of 'Stem-Cell Tourism'" [uncertain: year and citation details from secondary reports only]. [source: ipscell.com summary]
  • Autism treatment abroad. A UK family took their four-year-old autistic son to a clinic in Beijing for a one-month course costing £20,000, with repeated injections and daily drips that the family found distressing; they doubted whether stem cells were given at all and later called the clinic's continued recruitment fraud. [source: LaingBuisson IMTJ, 2013, family account]
  • Australia. A woman died in Sydney from complications of a stem-cell procedure sold to treat dementia, which helped prompt the July 2019 TGA changes. [source: University of Melbourne 2019]

How it caused harm

  • Direct injury to the eye. In the Florida cases, complications included raised eye pressure, haemorrhagic retinopathy, vitreous haemorrhage, combined traction and rhegmatogenous retinal detachment and lens dislocation; one year later vision ranged from 20/200 to no light perception, one woman was blinded and two had severe loss. The authors judged the preparations, not the injection technique, the probable cause. Injecting both eyes at once meant both eyes were exposed. [source: HCPLive/NEJM]
  • Infection. All 12 culture-confirmed patients in the 2018 series (Texas 7, Florida 4, Arizona 1) were hospitalised, for 4 to 58 days initially, with bloodstream infections, joint infections, epidural abscess, discitis, vertebral osteomyelitis and injection-site cellulitis caused by gut-type bacteria; none died. Contamination probably occurred before distribution; cord blood cannot be decontaminated after collection; outpatient settings may have weaker infection control. [source: CDC MMWR 2018]
  • Abnormal growth. Donor-derived cells can form tumour-like masses, as in the spinal case. [source: ipscell.com on Berkowitz et al.]
  • Wider harms. Reports worldwide include cancers, infections, strokes, cardiac arrest, blindness and death [source: University of Melbourne 2019]; FDA warns clinics put patients at risk "by delaying legitimate treatment" [source: FDA 2019 exosome alert]; Health Canada warns of life-threatening or life-altering harm, including serious infections [source: Health Canada 2019].
  • Financial and psychological harm. Out-of-pocket costs, unrecoverable payments (the Beijing family found no route to compensation), repeated rounds, and the distress, regret and guilt of patients and parents [psychological sequelae: synthesis; costs: sources above].
  • Who is most at risk. Older adults with degenerative eye, joint or brain disease; people with incurable neurological illness; people with chronic pain; parents of children with autism or cerebral palsy, to whom clinics have marketed directly. [source: HCPLive/NEJM; CDC MMWR 2018; KFF on Turner and Knoepfler 2016]

Recognising it today

  • Labels and rebrandings: "regenerative medicine", "stem-cell therapy", "your own cells", SVF, adipose-derived stem cells, BMAC, umbilical cord blood, Wharton's jelly, amniotic fluid products, exosomes. [source: FDA consumer alert; Health Canada 2019]
  • Claims: one product for many unrelated conditions (orthopaedic, neurological, autism, sight loss, COVID-19, fatigue, anti-ageing). [source: FDA consumer alert; KFF]
  • Warning signs from the ISSCR: testimonials as proof; unclear cell source or method; claims of no risk; high or hidden costs; no detailed protocol approved by an ethics committee. [source: ISSCR Handbook 2008]
  • Regulatory sleight of hand: "FDA-registered" offered as if it meant approved; paid treatment called a "study"; claims that the product falls outside drug rules, which FDA says is wrong. [source: CDC MMWR 2018; FDA statement 2019]
  • Settings: chiropractic, pain, orthopaedic, anti-ageing and aesthetic clinics; overseas packages. [source: CDC MMWR 2018; KFF; LaingBuisson]
  • Red flags in a colleague or service: referring clients to a clinic, holding a financial interest, selling products, writing endorsements, or describing these products as treatment for a disease [synthesis].
  • How legitimate versions differ: approved haematopoietic stem-cell products and transplants for blood-production disorders; clinical trials with an FDA IND number (or national equivalent), an ethics committee named on the consent form, a written protocol, no charge for the trial treatment, and specialists in the specific disease. [source: FDA consumer alert; FDA 2019 exosome alert; ISSCR Handbook 2008]

What to do instead and how to help those harmed

  • Safer alternatives: routes through the client's own specialist; standard care for the condition; legitimate trials found with the treating doctor or through ClinicalTrials.gov, as the ISSCR suggests; psychological support for pain, illness and caregiving (Domain II). [source: ISSCR Handbook 2008; rest synthesis]
  • Assessing affected clients: obtain (with consent) the medical picture from their doctors; check for ongoing symptoms needing care; screen for depression, suicidal thinking, trauma symptoms, health anxiety and financial crisis; explore regret and family blame [synthesis].
  • Treatment considerations: adjustment and grief work for lost sight or function; trauma-focused work for frightening complications; problem-solving for debt; family sessions for blame; liaison with rehabilitation services [synthesis].
  • Ethical, reporting and legal duties: report adverse events (FDA MedWatch; Health Canada adverse reaction line; national regulators elsewhere) and illegal marketing (Health Canada complaint form); refer safeguarding concerns for children and adults at risk; never sell, recommend or profit from these products; support clients who wish to seek legal advice. [source: FDA consumer alert; Health Canada 2019; rest synthesis]

Sources

Web sources:

Papers cited through the reports above:

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