Unproven therapies: what the medicines regulators say — and what it means for ANOVA IRM
This page takes up the warnings of the EMA, the FDA and the Paul-Ehrlich-Institut about unproven cell and tissue therapies and answers them point by point for ANOVA IRM: the treatments are experimental because there is no phase 3 efficacy evidence of its own, but the products are manufactured under official authorisation — a manufacturing authorisation under Section 13 AMG for BMC and a manufacturing authorisation under Section 20c AMG for MSC secretome — and regular inspection.
The answer up front
Medicines regulators such as the European Medicines Agency (EMA), the Paul-Ehrlich-Institut (PEI) and the US Food and Drug Administration (FDA) warn against so-called unproven therapies — cell and tissue therapies without proven benefit. This warning is justified. We take it up in full on this page and answer it point by point.
The answer in brief: manufacture at ANOVA IRM takes place under official authorisation, under GMP (BMC) and, for MSC secretome, under officially inspected good professional practice (GFP), and under regular official inspection. GFP is the German counterpart of Good Tissue Practice (GTP) in the US. Unlike a registration with the US FDA, which on its own is no official confirmation that the rules are met, GFP in Germany is a condition of the official authorisation and is regularly inspected by the authorities. ANOVA already implements some requirements of the new SoHO Regulation, which is already in force and — with a few exceptions — applies from 7 August 2027. There is no efficacy evidence from a confirmatory phase 3 trial of its own — which is why the treatments are experimental; administration takes place as an individual treatment attempt after comprehensive information of the patient, manufacture always under official authorisation.
ANOVA IRM is not an unregulated stem cell clinic. ANOVA IRM holds official authorisations for both products: for BMC a manufacturing authorisation under Section 13 of the German Medicinal Products Act (AMG), for MSC secretome as a tissue preparation a manufacturing authorisation under Section 20c AMG, which requires GFP and compliance with all AMG and AMWHV requirements for tissue preparations. In addition, ANOVA IRM holds procurement authorisations under Section 20b AMG for the bone marrow (BMC) and the adipose tissue (MSC secretome).
The warnings in the original
We do not paraphrase the warnings; we link to them. Anyone who wants to form their own view should read the original texts:
- EMA/CAT: EMA warns against using unproven cell-based therapies (PDF, 2020)
- EMA: Advanced therapy medicinal products – Overview
- FDA: Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes
- FDA: Patient and Consumer Warning about Unapproved Products from Human Cells or Tissues
- Paul-Ehrlich-Institut: advanced therapy medicinal products (ATMP) (German)
Two questions that must be kept apart
The regulators’ warning has two components that are often mixed up in public discussion: safety and efficacy. For each component we state openly once more where ANOVA IRM stands.
|
Aspect of the regulators’ warning |
What is meant |
Position of ANOVA IRM |
|---|---|---|
|
Safety — non-sterile or uncontrolled manufacture, contamination, uncharacterised products, absent batch testing, no traceability, no vigilance |
Manufacturing and quality risks at providers without official authorisation |
Addressed. GMP structure for BMC with a manufacturing authorisation under Section 13 AMG, GFP structure for MSC secretome with a manufacturing authorisation under Section 20c AMG, procurement in each case under Section 20b AMG; official inspection by the Hessian State Office for Health and Care (HLfGP), documented batch release and pharmacovigilance. Publicly verifiable in EudraGMDP. |
|
Efficacy — promises of cure without controlled trials |
Missing confirmatory efficacy evidence (phase 3) |
Stated openly. No phase 3 evidence of its own. The basis is medical evidence, scientific publications and, where available, phase 1 and 2 studies. Hence: experimental, individual treatment attempt, comprehensive information of the patient. |
Further details on GMP and GFP at ANOVA IRM are set out on the Regulatory Status page.
In short: a manufacturer can be officially authorised, inspected and GMP- or GFP-compliant without the product being approved for an indication. That is exactly the case at ANOVA IRM for both BMC and MSC secretome — the one yes, the other no.
The regulators’ checklist, answered
EMA and FDA recommend that patients ask providers of cell therapies specific questions. Here are exactly these questions — with our answer and the evidence for each. For simplicity we do not distinguish manufacture from processing in every row: in regulatory terms BMC is manufactured, while MSC secretome, as a tissue preparation, is processed.
|
Question recommended by the regulators |
Answer for ANOVA IRM |
Evidence |
|---|---|---|
|
Is the provider officially authorised to manufacture the product? |
Yes — for BMC a manufacturing authorisation under Section 13 AMG, for MSC secretome a manufacturing authorisation under Section 20c AMG; procurement in each case under Section 20b AMG |
|
|
Is manufacture officially inspected? |
Yes — regular risk-based inspections under Section 64 AMG by the HLfGP |
GMP certificate DE_HE_01_GMP_2025_0046 |
|
Is manufacture carried out under GMP? |
Yes — for BMC (mandatory). MSC secretome is processed under GFP; in selected areas — above all production, quality control and quality assurance — ANOVA has voluntarily applied the stricter standards used for ATMPs since 2018 and thereby already meets some requirements of the SoHO Regulation |
GMP certificate, SOPs |
|
Is every batch tested and released? |
Yes — documented testing and release procedure for every patient batch |
Batch records |
|
Are adverse reactions recorded and reported? |
Yes — pharmacovigilance obligations, reporting of serious suspected cases to the authority |
Quality management system |
|
Are promises of cure made? |
No — information about the limited data before every treatment |
Patient information form |
|
Is the product approved for the indication? |
No. There is no marketing authorisation under Section 21 AMG. Manufacture takes place under official authorisation; administration to the provider’s own patients takes place as an individual treatment attempt, for which no authorisation under Section 4b, no marketing authorisation under Section 21 and no approval under Section 21a AMG is required. Stem cell products approved in Germany and their manufacturers are listed on InCelligence.de. |
stated openly |
|
Is there efficacy evidence from a phase 3 trial? |
No. The basis is medical evidence, publications and phase 1 and 2 studies. |
Evidence pages per indication |
The last two rows matter to us. A self-assessment consisting only of ticks is no assessment. We name the gaps as clearly as the requirements that are met.
Which questions you should ask any provider of a stem cell treatment is explained in detail on the page About Stem Cells.
Further definitions and links to all authorisations and registers can be found on the Regulatory Status page.
What this means for you as a patient
You are not treated within an approved standard therapy. You are treated as part of an individual medical treatment attempt with either BMC or MSC secretome. The individual treatment attempt concerns the administration only: the products themselves are always manufactured at ANOVA IRM under official authorisation and inspection. An individual treatment attempt without such authorisations would be possible, but it would not be controlled. Administration as an individual treatment attempt is legally permitted and clearly regulated in Germany — but it means that efficacy for your indication cannot be regarded as proven, because we have not conducted a clinical trial.
For the process at ANOVA IRM this means:
- Every treatment is preceded by an individual medical benefit-risk assessment.
- Every treatment is preceded by comprehensive information about the limited data, possible risks and existing treatment alternatives, including established standard therapies.
- We always explain that for most stem cell therapies there is no completed phase 3 trial so far and that our treatments are not approved.
- We tell you the available scientific and clinical evidence for your indication and state explicitly what is not proven. We distinguish explicitly between phase 1, 2 and 3 studies.
- We make no promises of success and state no success rates that are not based on scientific or clinical studies.
If an effective, approved standard therapy is available for your condition, discuss this option explicitly with your treating doctor.
Our official authorisations at a glance
|
Authorisation / certificate |
Reference number |
Issued by |
|---|---|---|
|
Hessian State Office for Health and Care (HLfGP) |
||
|
EU GMP certificate |
Hessian State Office for Health and Care (HLfGP) |
|
|
Authorisation (procurement as well as manufacturing authorisation for the tissue preparation) under Sections 20b, 20c AMG |
Hessian State Office for Health and Care (HLfGP; issued at the time by Darmstadt Regional Council) |
|
|
Marketing authorisation under Section 21 AMG |
Not required for ANOVA IRM, as the products described here are not placed on the market; likewise no authorisation under Section 4b and no approval under Section 21a AMG. |
– |
Further reading
- Regulatory Status of ANOVA IRM — the core page: experimental and legal, chain of authorisations, authorities, registers
- GMP, GFP and batch release at ANOVA IRM
- SoHO Regulation 2027 and what ANOVA IRM has done since 2018
Frequently asked questions
What are “unproven therapies”?
The EMA and the FDA use the term unproven therapies for cell and tissue therapies whose efficacy and safety have not been demonstrated in controlled trials and which are often offered outside the legal routes — without a marketing authorisation, without an approved clinical trial, without the required manufacturing authorisations. The treatments at ANOVA IRM are not proven in phase 3 trials either and are therefore experimental; unlike at unregulated providers, however, manufacture takes place under official authorisation and inspection, and administration takes place as an individual treatment attempt under medical responsibility.
Do the EMA or FDA warn against ANOVA IRM?
No. The EMA and the FDA warn in general terms against cell and tissue therapies that are offered without official authorisation and without controlled manufacture; there is no warning against ANOVA IRM by name. ANOVA IRM relies on official authorisations — for BMC under Sections 20b and 13 AMG, for MSC secretome under Section 20b AMG and a manufacturing authorisation under Section 20c AMG — and, for administration to its own patients, needs no authorisation under Section 4b, no marketing authorisation under Section 21 and no approval under Section 21a AMG, because it does not place its products on the market. We consider the general warning justified and answer it point by point on this page.
What is the difference between “experimental” and “illegal”?
They are two different things. Experimental means: for this product in this indication there is no phase 3 efficacy evidence of its own. Legal means: the official authorisations required by law are in place for both BMC and MSC secretome. A treatment can be both at the same time — and at ANOVA IRM it is.
Is “GMP-certified” the same as “approved”?
No. A GMP certificate confirms that manufacture meets the requirements of Good Manufacturing Practice and has been officially inspected. A marketing authorisation under Section 21 AMG confirms that the quality, safety and efficacy of a product have been demonstrated for a specific indication. ANOVA IRM holds a GMP certificate for the manufacture of BMC; MSC secretome is processed under GFP on the basis of the manufacturing authorisation under Section 20c AMG and is also officially inspected. There is no marketing authorisation, and none is required, because ANOVA IRM does not place its products on the market; for the same reason no approval under Section 21a or authorisation under Section 4b AMG is needed.
Is stem cell therapy safe?
Not without qualification: like any medical treatment, stem cell therapy carries risks, for example at the collection site or through temporary reactions; your doctor discusses your individual risks with you during the informed-consent consultation. Safety can be influenced above all through the quality of the product: following the logic of the authorities, products from an officially authorised and inspected manufacturer are to be regarded as safer than products from unregulated providers. So ask providers about their authorisations and certificates!
Is an experimental stem cell therapy risk-free?
No — no medical treatment is risk-free, and an effect cannot be guaranteed; which risks apply in your case is clarified in the informed-consent consultation with your doctor. What can be reduced above all is the risk arising from the product itself: official authorisations, manufacture under GMP (BMC) or processing under GFP (MSC secretome) and the testing of every single batch limit manufacturing and quality risks — which is why, in the regulators’ logic, products from such manufacturers count as safer than those from unregulated providers. Ask to see authorisations and certificates!
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 Prostate Center. Because imaging is carried out in the same building, condition-specific diagnostics — including CT-guided procedures — are performed in-house rather than referred elsewhere. See diagnostics at ANOVA IRM.
Last medically reviewed on 8 September 2026