Cell culture under a laminar flow hood: a multichannel pipette dispenses culture medium into a multi-well plate, ANOVA IRM, Germany.
 

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Stem Cell Medicine Put to the Test:
Eight Countries Compared

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Germany takes first place in the regulation of stem cell medicine. Stem cell treatments are sold commercially in dozens of countries, at prices that commonly run into five figures. The legal regimes behind them differ far more than the marketing does. We asked four questions that any patient can put to any clinic, and applied them to eight jurisdictions. Germany is the only one that answers all four.

In short: We scored eight countries on four questions: who licenses and inspects manufacture, whether the product itself is assessed, who releases each batch, and whether harm must be reported. Germany answers all four, Japan three. The comparison concerns legal frameworks, not individual clinics, and it says nothing about whether a treatment works.

Patient information · Read time: about 24 minutes

ComponentDetail
Two products Bone Marrow Concentrate (BMC) and Mesenchymal Stem Cell Secretome (MSEC), each manufactured under official authorisation; no marketing authorisation (experimental)
Authorisations BMC § 20b / § 13 AMG · MSEC § 20b / § 20c AMG (German Medicines Act)
Location Offenbach am Main, Germany
Portrait of Dr. med. Dr. phil. Dr. med. habil. Michael K. Stehling, founder and medical director of ANOVA IRM.
Author and medically reviewed by

Dr. med. Dr. phil. Dr. med. habil. Michael K. Stehling

Dr. Stehling is a physicist and physician who was involved in the development of Magnetic Resonance Imaging (MRI) with Nobel laureate Sir Peter Mansfield. He founded ANOVA IRM in Offenbach, Germany, where autologous mesenchymal stem cell secretome (MSEC) and bone marrow concentrate (BMC) are manufactured under German regulatory authorisation and official inspection.

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The result

Scored against the four questions on this page, and against nothing else. A question counts as answered only where the framework answers it in full; partial coverage does not count. Each mark refers to the legal framework of the country, not to any individual clinic within it.

Country1 — Manufacture licensed by a named authority and inspected2 — Product itself assessed by a regulator3 — Named person legally responsible for releasing each batch4 — Mandatory adverse-event reporting to a public authorityQuestions answered
Germany Yes Yes Yes Yes 4 of 4
Japan Yes Conditional Not in this form Yes 3 of 4
India Partly No Partly Partly 0 of 4
United States Registration only No No Partly 0 of 4
Panama Partly No No No 0 of 4
Thailand Partly No No No 0 of 4
Mexico Partly No No No 0 of 4
Costa Rica No No No No 0 of 4

Germany answers all four

Germany is the only country in this comparison that does. Manufacture is licensed by a named authority and inspected under § 64 AMG. The product is assessed separately from the premises, by the Paul-Ehrlich-Institut or the European Medicines Agency. Every batch is released in writing by a named Qualified Person who is personally liable for that signature. Adverse events must be reported to the federal institute. Germany is also one of only two EU member states that publishes the authorised products together with their product information.

Japan comes closest, and deserves the credit

It is the only other country here that regulates cell-processing facilities for ordinary clinical practice rather than only for trials. It is also the only one outside Europe with a product assessment route at all. Its conditional approval pathway is a serious attempt to reach patients faster without abandoning oversight. When one conditionally approved product failed to demonstrate efficacy in 2024, the ministry refused to convert it to full approval. That is a regulator doing its job. The gap is that approval can precede proof, and that the responsibility for an individual batch is not attached to a single named person in the way European law requires.

Everywhere else, the first three questions have no answer

That is not a judgement about the physicians working in those countries. It is a statement about what a patient is able to verify before travelling. In most of these jurisdictions, that is the licence of the building and very little else.

One thing this scoring does not measure, and cannot. A framework that answers all four tells you that what you receive has been manufactured under licence, assessed by a regulator, released by a person who signed for it, and traced if it causes harm. It does not tell you that the treatment will work. No regulator in any country certifies that, and anyone who tells you otherwise has misunderstood what a marketing authorisation is.

How we arrived at that result

The method is deliberately narrow. Four questions, each with a factual answer that a provider can give in a sentence or cannot give at all. They are applied to the law of each country rather than to the reputation of any clinic within it.

Question 1 — Who licensed the manufacture, and who inspects it?

A clinic may be registered to treat patients and still have no authorisation to manufacture what it injects. These are two different permissions from two different authorities. Ask which authority issued the manufacturing licence, under which legal provision, and when the facility was last inspected. A licence number you can check against a public register is worth more than any certificate on a wall.

Question 2 — Has the product been assessed, or only the premises?

A clean room is not a medicine. Cell preparations can be made in an inspected facility and still never have been assessed for what they contain or what they do. Ask whether the preparation itself has been through a regulatory assessment, and under what status it is supplied: approved medicinal product, hospital exemption, named-patient supply, or clinical trial. Each of these means something different, and a clinic that cannot name which one applies is telling you something.

Question 3 — What exactly is being injected, and who released the batch?

“Stem cells” is not a specification. Ask which cell type, from which source, at what dose, expanded over how many passages, and tested for what: sterility, endotoxin, mycoplasma, viability, identity. Then ask who signs the release of each batch and what qualification that person holds. In the EU this is a named Qualified Person with personal legal responsibility. Elsewhere the answer is sometimes that nobody does.

Question 4 — What happens if something goes wrong?

Ask where adverse events are reported and to whom, whether the clinic is obliged to report them, and what liability cover exists. Then ask what recourse you have from your home country. Litigation across borders is slow, expensive and frequently pointless. This is the question patients ask last and should ask first.

The four checkpoints of stem cell regulation, ANOVA IRM, Germany: manufacture, the preparation, batch release and reporting of harm under German law compared with countries without a comparable framework.
The four points at which a cell preparation can be checked, and who checks them. A clinic licence covers the premises; it says nothing about the three stages that follow. Original diagram, ANOVA IRM.

The countries in detail

What follows describes legal frameworks, not the quality of individual clinics. A country with a weak framework may still contain careful physicians, and a strong framework is no guarantee that a given treatment will work. The point of the table is narrower: it shows what you are able to verify for yourself before you travel.

CountryRegulator and legal basisManufacture licensed and inspected?Is the product itself approved?What you can check yourself
United States FDA. Public Health Service Act § 361 vs § 351; 21 CFR Part 1271 Registration only, for most clinics. Registering a tissue establishment is not approval, and the FDA says so in terms Not for the usual offers. The first mesenchymal stem cell therapy was approved only in December 2024, for one narrow paediatric indication. No approved adipose, exosome or amniotic product exists for orthopaedic, neurological, autism or anti-ageing use FDA establishment registration database; the list of licensed cell and gene products; published warning letters. A listing on ClinicalTrials.gov proves nothing about legality; again, the FDA says so
Mexico COFEPRIS. General Health Act, Title 14, Art. 315 Establishments are licensed, in three categories. But no Norma Oficial Mexicana governs the therapies themselves, despite calls since 2015 No. The rules cover collection facilities and biobanks, not clinical application Yes, and it is worth doing. COFEPRIS publishes the official list of licensed regenerative-medicine establishments. One study of Tijuana clinics found thirteen claiming a licence; on checking, only one matched the register for both name and address
Panama Ministry of Health. Law No. 3 of 2010; Executive Decree No. 179 of 2018 Licence required for extraction and transplantation of anatomical components No. The 2018 decree follows ISSCR guidance: only haematopoietic transplantation for blood disease is accepted practice; everything else is experimental Yes. Exactly four centres hold an active licence, all for haematopoietic stem cells, and all four are named in the published literature. A 2026 survey found six further businesses marketing unproven treatments at $5,000 to $50,000, none of them licensed for it
Thailand Thai FDA; Department of Health Service Support; Medical Council of Thailand (2011 rule) Facilities are licensed. But autologous cells have not been treated as drugs under the Thai Drug Act, so the Thai FDA has not assessed them Only two exceptions: haematopoietic stem cells for blood disease, and cultivated corneal epithelial cells for limbal stem cell deficiency Under the 2011 Medical Council rule, any procedure placing stem cells in the body counts as research and needs ethics committee approval; a doctor who ignores this risks their licence. A Cell Therapy Act has been drafted but was still not in force at the last published account
Costa Rica Ministry of Health. No framework specific to cell therapies identified No separate manufacturing licence for cell preparations could be identified No The precedent is instructive. The country’s largest stem cell clinic held a permit to store cells but not to administer them; the ministry halted it in 2010. It reappeared in Panama in 2013, having previously operated in India and Mexico, a pattern worth knowing about
Japan MHLW and PMDA. Act on the Safety of Regenerative Medicine, and the PMD Act, both in force since November 2014 Yes, and unusually so. Japan regulates cell-processing facilities for ordinary clinical practice, not only for trials. Plans go to a certified committee and to the ministry Conditionally. A product can reach the market on early-phase data, with a time limit and a requirement to prove itself afterwards The ministry’s public register of submitted treatment and research plans. Note the proportions: as of 2023 there were 3,868 higher-risk treatment protocols against 48 higher-risk research protocols
Germany Regional authority for the facility; Paul-Ehrlich-Institut for the product. §§ 13, 20b, 20c, 21a, 4b and 64 of the Medicinal Products Act (AMG) Yes. Manufacture requires a licence from the state authority, granted in concert with the federal institute, and the premises are inspected under § 64 AMG. A named Qualified Person must certify every batch in writing before release, personally A separate question, and the one to press on. § 21a covers only haematopoietic stem cells for restoring blood formation. An advanced therapy supplied to others needs either a European marketing authorisation or a specific national authorisation under § 4b(3). A preparation made and given in-house to the clinic’s own patients needs no marketing authorisation, but still the manufacturing authorisation, in which the Paul-Ehrlich-Institut is involved Yes. EudraGMDP lists manufacturing authorisations and GMP certificates across the EU. Germany is one of only two member states that publishes the authorised products together with their product information
India CDSCO. Drugs and Cosmetics Act 1940; New Drugs and Clinical Trials Rules 2019 Manufacture is licensed by state drug authorities. The national stem cell research guidelines are not legally enforceable Essentially no. Haematopoietic transplantation, plus one licensed product for last-line critical limb ischaemia. Everything else belongs in a trial Clinical Trials Registry India: registration has been mandatory before first enrolment since 2018

Countries sometimes named in this context (the Cayman Islands, Ukraine, Russia, the Bahamas) are left out because no authoritative, current regulatory source could be identified for them. That absence is itself worth knowing before you travel to one.

Japan shows that the choice is not between speed and safety

It is the most interesting case, and it cuts against the simple story.

Since 2014 Japan has run a system no one else has. Cell preparations used in ordinary clinical practice, not only in trials, must be made in a regulated facility. The treatment plan must be reviewed by a certified committee and filed with the ministry. Alongside it sits a conditional approval route that lets a product reach the market on early-phase evidence, with a time limit attached.

That design was meant to get regenerative medicine to patients faster without abandoning oversight. It has been heavily criticised by researchers, including Japanese ones. One product was conditionally approved on data from seven patients. Review committees have been found to sit too close to the institutions they review. And the therapy track has filled up far faster than the research track.

But the conditional route did something the critics may not have expected. In July 2024 the ministry examined the post-marketing data for that seven-patient product, concluded it had not demonstrated efficacy, and refused to convert it to full approval. A regulator took a product off its own fast lane.

That is the point worth taking from Japan. Regulation is not the opposite of access. It is the thing that decides, afterwards, whether what you were given actually worked, and tells you so.

What a German manufacturing licence actually involves

We set this out at length because it is the part most often invoked and least often explained. The distinctions inside it matter more than the word “regulated”.

German law separates permissions that elsewhere are blurred together. A licence to run a clinic is not a licence to manufacture. A licence to manufacture is not an approval of the product. And an approval of one product says nothing about the next.

The facility

Manufacturing medicinal products requires a licence under § 13 AMG. Procuring human tissue and performing the laboratory tests on it requires a separate licence under § 20b AMG. Processing, preserving, testing, storing or placing tissue preparations on the market requires another under § 20c AMG, granted by the authority of the federal state in concert with the Paul-Ehrlich-Institut. Each is refused unless the premises are suitable, the staff are qualified, a quality management system is in place, and the work follows the current state of science. Under § 64 AMG the facility is then subject to official inspection, with federal experts brought in for advanced therapies.

The person

A licence requires a named Qualified Person with a defined degree and at least two years of practical analytical experience. Under § 19 AMG that individual must certify, for every single batch, in a continuous register, that it was manufactured and tested according to the rules, before it may be released. The responsibility is personal and it attaches to a name. This is the answer to the third of our four questions, and in many countries there is no equivalent answer at all.

The product: where the real distinction lies

None of the above says a word about whether a preparation works. Product authorisation is a separate track, and it is tied to one act: placing a preparation on the market, or supplying it to others. § 21a AMG covers tissue preparations whose effects are already established in the scientific literature. The Paul-Ehrlich-Institut states plainly what that amounts to in practice: haematopoietic stem cells from bone marrow, peripheral blood or cord blood, for restoring blood formation. Nothing else. An advanced therapy medicinal product that is supplied to others requires either a European marketing authorisation or a specific national authorisation under § 4b(3) AMG, which demands a dossier including pharmacological and toxicological data, a benefit–risk assessment and a risk management plan.

As of the most recent published survey, ten products held such a national authorisation in Germany. Not ten thousand. Ten.

There is a third case, and it is the route ANOVA’s own preparations take. A preparation made in-house for an individual patient, and given there under a physician’s responsibility, is not placed on the market. It needs no marketing authorisation, but it still needs the manufacturing authorisation, the inspections and the named person who releases each batch. The Paul-Ehrlich-Institut is involved in granting that authorisation, reviews the preparation as part of it and takes part in the inspections. What such a preparation does not have is a regulator’s finding that it works; that can only come from clinical trials.

Why the structure matters more than the word “regulated”

Almost every country in the table can say, accurately, that stem cell treatment there is regulated. What differs is what the regulation reaches. German law places a separate requirement at each of the three points where something can go wrong: the facility, the person who releases the batch, and the preparation itself. Each one is independently verifiable from outside. That is the difference between a framework that governs the practice and one that merely registers it.

What the literature records

Documented cases from peer-reviewed journals and regulatory records, not anecdotes. They are summarised briefly because the point is not the detail of any one case but what all of them have in common.

  • Serious vision loss after injections for macular degeneration, 2017. Three patients at one clinic received fat-derived “stem cells” into both eyes. All three lost substantial vision. New England Journal of Medicine.
  • A spinal cord lesion after treatment in three countries, 2016. A patient who had received intrathecal stem cell injections abroad developed a growing mass in the spinal cord. New England Journal of Medicine.
  • Twelve patients infected from one contaminated product, 2018. Umbilical cord blood preparations distributed in the United States were found to carry bacterial contamination; all twelve recipients required hospital treatment. The US Centers for Disease Control noted that the companies involved were registered with the FDA, and that registration is not approval. This is question one and question three, in a single case.
  • A tumour derived from the donor cells, 2009. A patient treated abroad with fetal neural stem cell injections later developed a multifocal tumour. Genetic analysis showed it originated from the donated cells rather than the patient’s own. PLoS Medicine.
  • Tissue growths at the injection site, 2010. A patient given her own blood stem cells injected directly into a kidney developed masses at the injection sites that required surgery. The pathology was a lesion not previously described. Journal of the American Society of Nephrology.

These are not typical outcomes, and they are not on their own a reason to prefer one country over another. They are included because they share a single feature: in each case the preparation was given without any authority having assessed what it contained or what it would do. That is the gap the four questions are designed to find.

Frequently asked questions

Questions patients ask us about stem cell treatment abroad, answered at the level of what can be verified.

What is the difference between a clinic licence and a manufacturing licence?

They are issued by different authorities for different things, and conflating them is the single most common misunderstanding in this field. A clinic licence permits the treatment of patients on those premises. A manufacturing licence permits the production of the preparation that is injected. A clinic may hold the first and not the second. Then the thing being injected has been made somewhere, by someone, under conditions nobody has examined.

A clinic says it is “FDA-registered”. What does that actually mean?

It means the establishment has filed its existence with the FDA, which is a form submission, not an assessment. The FDA states in its own patient guidance that registration and listing do not constitute approval and that firms should not represent it as such. If a clinic’s strongest regulatory claim is registration, that tells you the product has not been reviewed.

The clinic’s treatment is listed on ClinicalTrials.gov. Is that an approval?

No. Registration on that database is largely self-reported and does not mean the study has been reviewed or authorised by the FDA. Some unapproved commercial treatments have been listed there while patients were being charged to take part. That is itself a signal worth noticing, since participants in a properly regulated trial do not usually pay for the intervention.

What is a Qualified Person, and why does it matter so much?

It is the named individual who must certify every batch before release, and it matters because responsibility then attaches to a person who can be held to account. Under § 19 AMG that person holds a defined qualification and at least two years of practical analytical experience. They record, in a continuous register, that the batch was manufactured and tested according to the rules. In much of the world no equivalent signature exists, and the honest answer to “who released this batch?” is nobody.

Is a treatment using my own cells less regulated, or safer?

Less regulated in some countries, which is a different claim from safer. Autologous origin removes the risk of immune rejection and of transmitting a donor’s disease. It does not remove the risks that come from processing: contamination during handling, the behaviour of cells after expansion, and the consequences of injecting them into a site they do not belong in. Several of the documented harms on this page involved patients’ own cells. More on autologous and donor cells.

Why are stem cell treatments so much cheaper abroad?

Partly lower operating costs, and partly because the steps that cost money in a regulated system are not being carried out: licensed manufacture, product assessment, release testing, batch documentation, pharmacovigilance. A price difference of that kind is not a bargain so much as an itemised list of what has been left out.

Can I check a stem cell clinic’s licence myself before I travel?

In several countries, yes, and it is worth the hour it takes. The EU publishes manufacturing authorisations and GMP certificates in EudraGMDP. Mexico’s COFEPRIS publishes the official list of licensed regenerative-medicine establishments. The FDA publishes its establishment registrations, its list of licensed cell and gene therapy products, and its warning letters. Japan’s ministry publishes submitted treatment plans. Check the name and the address against the register, not just the name.

What does Japan’s “conditional approval” mean?

It allows a product onto the market on the strength of early-phase data showing safety and probable benefit, with a time limit and an obligation to demonstrate efficacy afterwards. It is a genuine assessment, not a formality, and it can end in refusal. In July 2024 the ministry declined to convert one conditionally approved cardiac product to full approval after its post-marketing data failed to demonstrate efficacy.

Does an approval ever get withdrawn?

Yes, and it is a sign the system works rather than a sign it does not. Alofisel, an allogeneic stem cell therapy authorised in the EU in 2018, had its marketing authorisation withdrawn in 2024 after a confirmatory trial did not confirm the original result. A framework that can take a product back is a framework that was actually examining it.

What should I do if a clinic will not answer these questions in writing?

Treat that as the answer. Every question on this page has a factual reply that a compliant provider can give in a sentence. A provider who is unwilling to put a licence number or a regulatory status in an email is unlikely to produce either when something goes wrong. Keep the correspondence; it is also what your own physician at home will want to see.

What happens if something goes wrong after stem cell treatment abroad?

Ask before you go, not after. Establish where adverse events are reported and whether reporting is mandatory, what liability cover the provider holds, and in which jurisdiction a claim would have to be brought. Then ask who manages the follow-up when you are home, and at whose cost. Cross-border litigation in health care is slow, expensive and frequently unsuccessful. Your domestic insurer will not usually cover the consequences of an unapproved treatment obtained elsewhere.

Does a strong regulatory framework mean the treatment will work?

No, and this is the distinction the whole page rests on. Regulation establishes how a preparation is manufactured, tested, released and traced. Efficacy for a particular condition is a separate question, answered only by clinical evidence for that condition, not by evidence about stem cells in general. Ask what the published evidence is for your indication, and be wary of any answer that changes the subject.

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Who is publishing this, and why

This page is published by the ANOVA Institute for Regenerative Medicine in Offenbach am Main, Germany. We manufacture and administer cell preparations. We are therefore one of the providers that a patient comparing options would be comparing.

We have an obvious interest in how this comparison turns out. That is precisely why the questions above are framed as questions rather than claims. Every one of them can be put to us, and the answers can be checked against public registers rather than taken on trust. If you take only one thing from this page, take the checklist at the end and use it on us as well.

Nothing here should be read as a claim that cell-based treatments will help any particular condition. Regulation governs how a preparation is made, tested and released. It does not establish that it works. Those are separate questions and we have tried not to blur them.

Our own answers to the four questions

Held to the same standard, and stated so that each point can be checked against a register rather than taken on trust.

Our answer to question 1: licence and inspection

ANOVA holds three authorisations under the German Medicinal Products Act (AMG), granted by the competent authority of the State of Hesse in concert with the Paul-Ehrlich-Institut. This was originally the Darmstadt Regional Council, and since 1 January 2023 is the Hessian State Office for Health and Care (HLfGP):

  • Bone marrow concentrate (BMC): a manufacturing authorisation under § 13(1) AMG, no. DE_HE_01_MIA_2022_0094, and a GMP certificate, no. DE_HE_01_GMP_2025_0046.
  • Collection of the patient’s own tissue and MSC secretome (MSEC): authorisations under § 20b AMG for collection (procurement) and under § 20c AMG for processing the MSC secretome, no. DE-RPDA-18L18.01-1703-B-1-O.

The facility is inspected by the HLfGP under § 64 AMG, routinely every two years. The manufacturing authorisation under § 13 AMG and the GMP certificate are listed in the European EudraGMDP database. ANOVA is also listed as a tissue establishment in the EU Tissue Establishment Compendium. Both registers can be searched by anyone, free of charge.

The Paul-Ehrlich-Institut also takes part in the inspections. The last inspection took place in 2024; the next is scheduled for 2 and 3 December 2026.

Our answer to question 2: assessment of the product

These are different things and we separate them. A manufacturing authorisation concerns how a preparation is made, tested and released; it is not a statement that the preparation is effective.

Neither ANOVA preparation holds a marketing authorisation, and neither needs one, because both are made for and given only to ANOVA’s own patients and are not placed on the market:

  • BMC is an advanced therapy medicinal product, prepared under the hospital exemption of § 4b(1) AMG. A separate authorisation under § 4b(3) AMG is required only when a preparation is supplied to others, which ANOVA does not do.
  • MSEC is a tissue preparation, processed under § 20c AMG. An authorisation under § 21a AMG is required only for placing a tissue preparation on the market, which ANOVA does not do.

The preparations are nevertheless assessed: the Paul-Ehrlich-Institut is involved in granting both authorisations, reviews the preparation as part of that process and takes part in the inspections. Both preparations are given as an individual therapeutic attempt (individueller Heilversuch) after a personal medical assessment and informed consent, not within a clinical trial.

Our answer to question 3: what is injected and who releases it

Each batch is released before use by a named person who is personally and legally responsible: for BMC by the Qualified Person under §§ 14 and 19 AMG, for MSEC by the responsible person under § 20c AMG. Both certify that the batch was manufactured and tested according to the rules.

  • BMC: cells from the patient’s own bone marrow, taken from the pelvic bone and concentrated about sixfold, not cultured and not frozen, applied on the day of collection. Tested before application: nucleated cell count, cell concentration, viability, appearance, agglutination and final volume. A sample for microbiological control is taken before application; its result is available after seven days. Endotoxin is not tested, because all materials used are endotoxin-tested.
  • MSEC: the cell-free secretome of the patient’s own mesenchymal stem cells, grown from fat tissue collected by mini-liposuction; up to ten doses per collection, stored at −80 °C. Tested on every batch before release: viable cell count and viability of the cultured cells, MSC identity, sterility, endotoxin, mycoplasma, particle content (approximate content of extracellular vesicles), total population doublings, total culture time, final volume and number of vials.

Our answer to question 4: if something goes wrong

Suspected adverse reactions are documented. Suspected serious adverse reactions are reported to the competent authority without delay, investigated and assessed, as German medicines law requires (pharmacovigilance).

ANOVA IRM and its physicians hold professional and business liability insurance. The treatment contract is governed by German law; the place of jurisdiction is Offenbach am Main.

We make no claim on this page that cell-based treatments will help any particular condition. What is set out above concerns how preparations are manufactured, tested and released, not what they achieve. Anyone who conflates the two, including us, should be asked to separate them again.

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Take this with you

Twelve things to ask any clinic, anywhere, including this one. Print it, send it by email, and keep the replies in writing.

  1. The name of the authority that issued the manufacturing licence, and the licence number
  2. The legal provision the licence is granted under
  3. The date of the most recent inspection, and by whom
  4. The regulatory status of the preparation itself, in writing
  5. The cell type, source, dose and number of passages
  6. The release tests performed on the batch I will receive
  7. The name and qualification of the person who releases the batch
  8. Whether my treatment is part of a registered clinical trial, and if so its registration number
  9. Where adverse events are reported, and whether reporting is mandatory
  10. What liability insurance exists, and in which jurisdiction a claim would be brought
  11. What the published evidence is for my indication, not for stem cells in general
  12. What happens, and what it costs, if I need follow-up care at home

A clinic that answers all twelve without hesitation is not necessarily offering you an effective treatment. But a clinic that cannot answer the first seven is not offering you a regulated one. More on choosing a stem cell clinic.

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Important Pages

Questions people usually ask next. Each is answered in full on its own page.

Affiliations of ANOVA

ANOVA IRM shares its premises in Offenbach with two further institutions owned by Dr. Stehling: the Institut für Bildgebende Diagnostik (IBDO), providing MRI and CT imaging, and the VITUS PRIVATKLINIK Prof. Dr. Stehling GmbH. Because imaging is carried out in the same building, diagnostics can be performed in-house rather than referred elsewhere. See diagnostics at ANOVA IRM.

References

References are grouped by type. Statutory and regulatory sources are cited so that each can be located in the issuing authority’s own register; peer-reviewed sources link to their DOI. Where no authoritative current source could be identified for a jurisdiction, it has been left out of this page rather than described from secondary accounts.

Statute and regulation

Registers a patient can search

Regulatory guidance and determinations

Peer-reviewed analyses of the market and its regulation

Documented adverse outcomes

Professional society guidance

This page describes regulatory frameworks for patient information. It makes no claim about the efficacy of any treatment and does not replace an individual medical consultation.

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