Unproven therapies: what the medicines regulators say — and what it means for ANOVA IRM

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 — unproven cell and tissue therapies. This warning is justified. We address it in full on this page and answer it point by point.

The answer in two sentences: manufacturing at ANOVA IRM takes place under official authorisation, under GMP/GFP conditions and subject to regular official inspection. ANOVA already implements requirements of the new SoHO Regulation, which is already in force and — with a few exceptions — applies from 7 August 2027. Proof of efficacy from our own confirmatory Phase 3 study is not available — which is why the treatments are experimental and are carried out as an individual therapeutic attempt (individueller Heilversuch) after comprehensive patient information.

ANOVA IRM is not an unregulated stem cell clinic. ANOVA IRM holds an official manufacturing authorisation under Section 13 of the German Medicinal Products Act (AMG) for BMC and tissue authorisations under Sections 20b and 20c AMG (a procurement authorisation for bone marrow as the basis for BMC and adipose tissue as the basis for MSC secretome, and a processing authorisation for the 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:

Two questions that must be kept apart

The regulators' warning consists of two components that are often conflated in public debate: safety and efficacy. For each component, we again state openly here where ANOVA IRM stands.

Aspect of the regulators' warning	What is meant	ANOVA IRM's position
Safety — non-sterile or uncontrolled manufacturing, contamination, uncharacterised products, missing batch testing, no traceability, no vigilance	Manufacturing and quality risks with providers that lack official authorisation	Addressed. GMP/GFP structure with a manufacturing authorisation under Section 13 AMG, authorisations under Sections 20b and 20c 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 studies	Missing confirmatory proof of efficacy (Phase 3)	Openly stated. No confirmatory Phase 3 proof of our own. The basis is medical evidence, scientific publications and, where available, Phase 1 and 2 studies. Therefore: experimental, individual therapeutic attempt, comprehensive patient information.

Further details on our GMP/GFP requirements are set out on our GMP/GFP legal page.

In short: a manufacturing operation can be officially authorised, inspected and GMP-compliant without the manufactured product being authorised for an indication. Both apply at ANOVA IRM, for both BMC and the MSC secretome — the one yes, the other no.

The regulators' checklist, answered

EMA and FDA advise patients to ask cell therapy providers specific questions. Here are exactly those questions — with our answer and the respective evidence. For simplicity, we do not distinguish manufacturing from processing in every block here. In regulatory terms, BMC is manufactured; the MSC secretome is processed as a tissue preparation.

Question recommended by the regulators	Answer for ANOVA IRM	Evidence
Is the provider officially authorised to manufacture the product?	Yes — manufacturing authorisation under Section 13 AMG, authorisations under Sections 20b and 20c AMG	EudraGMDP, EU Tissue Establishment Compendium
Is manufacturing officially inspected?	Yes — regular risk-based inspections under Section 64 AMG by the HLfGP	GMP certificate DE_HE_01_GMP_2025_0046
Is manufacturing carried out under GMP?	Yes — mandatory for BMC; for the MSC secretome voluntarily aligned with ATMP level since 2018. ANOVA already implements SoHO requirements	GMP certificate, SOPs
Is every batch tested and released?	Yes — documented testing and release procedure per patient batch	Batch documentation
Are adverse reactions recorded and reported?	Yes — pharmacovigilance obligations, reporting of serious suspected cases to the authority	QM system
Are promises of cure made?	No — information about the limited evidence before every treatment	Informed consent form
Is the product authorised for the indication?	No. There is no marketing authorisation under Section 21 AMG. The treatment is carried out as an individual therapeutic attempt.	openly stated
Is there proof of efficacy from a Phase 3 study?	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-declaration that contains only ticks is not information. We name the gaps as clearly as the requirements we meet.

Further definitions and links to all authorisations, registers, etc. can be found on our GMP/GFP legal page.

What this means for you as a patient

You are not being treated within an approved standard therapy. You are treated within an individual medical therapeutic attempt, either with BMC or MSC secretome. This is legally permissible 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 study.

For the process at ANOVA IRM, this means:

Before every treatment there is an individual medical benefit-risk assessment.
Before every treatment there is comprehensive information about the limited evidence, about possible risks and about existing treatment alternatives, including established standard therapies.
We always explain that so far there is virtually no genuine Phase 3 study for any stem cell therapy and that these therapies are all as yet unapproved.
We tell you the available scientific and clinical study data for your indication and explicitly state what is not proven. Here we explicitly distinguish Phase 1, 2 and 3 studies.
We make no promises of success and cite no success rates that are not based on a scientific or clinical study foundation.

If an effective, approved standard therapy is available for your condition, discuss this option explicitly with your treating physician.

Frequently Asked Questions

Is ANOVA IRM legal?

Yes. ANOVA IRM manufactures its products on the basis of official authorisations under Sections 13, 20b and 20c AMG. These authorisations are granted by the Hessian State Office for Health and Care (HLfGP) and reviewed through regular inspections under Section 64 AMG. They are publicly viewable in the European database EudraGMDP and in the EU Tissue Establishment Compendium.

Does the EMA warn against ANOVA IRM?

No. The EMA/FDA, together with the European medicines authorities, warns generally against unregulated or illegally provided advanced therapies. Lawful regulatory routes may — depending on the product and application — comprise a marketing authorisation, an approved clinical trial or, where the requirements are met, a national hospital exemption. For the treatments described here, ANOVA IRM relies not only on a hospital exemption but on the official authorisations presented on this page. There is no warning that names ANOVA IRM. We consider the general warning justified and answer it point by point on this page.

What is the difference between “experimental” and “illegal”?

These are two different things. Experimental means: for this product in this indication there is no confirmatory Phase 3 proof of efficacy of its own. Legal means: the legally required official authorisations are in place for both BMC and the 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 manufacturing 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. There is no marketing authorisation, and none is required, because ANOVA IRM does not place the products on the market.

Which products does this concern?

Bone Marrow Concentrate (BMC) as an advanced therapy medicinal product (ATMP) and the MSC secretome as a tissue preparation. For BMC there are a procurement authorisation under Section 20b AMG and a manufacturing authorisation under Section 13 AMG. For the MSC secretome there are authorisations under Sections 20b and 20c AMG.

How can I verify this myself?

Via the public registers. The manufacturing authorisation and the GMP certificate are held in EudraGMDP; the tissue authorisation is in the EU Tissue Establishment Compendium. You will find the identifiers in the overview below.

Is ANOVA a clinic?

ANOVA IRM is associated with the Vitus Private Clinic. Both companies are operated by Dr. mult. Michael K. Stehling. In the narrow sense of the German interpretation of the word “clinic”, ANOVA is therefore not a clinic but a private medical institution. ANOVA IRM manufactures the stem cell products (BMC and MSC secretome).

Our official authorisations at a glance

Authorisation / certificate	Identifier	Issued by
Manufacturing authorisation under Section 13 AMG	DE_HE_01_MIA_2022_0094	Hessian State Office for Health and Care (HLfGP)
EU GMP certificate	DE_HE_01_GMP_2025_0046	Hessian State Office for Health and Care (HLfGP)
Tissue authorisation under Sections 20b, 20c AMG	DE-RPDA-18L18.01-1703-B-1-O	competent regional authority
Marketing authorisation under Section 21 AMG	Not required for ANOVA IRM, as the products described here are not placed on the market.	–

Note for international readers: HLfGP and the Paul-Ehrlich-Institut (PEI) are the competent German medicines authorities — functionally comparable to the FDA in the USA, although in Germany inspection (state level) and marketing authorisation (federal level) are separate.