German Stem Cell Engineering — Innovative. Legal. Licenced
ANOVA Institute for Regenerative Medicine, Germany
ANOVA IRM is a private medical institute in Offenbach am Main, Germany, near Frankfurt, treating patients in five areas: neurology, joint and back pain, spinal cord injury, erectile dysfunction and anti-ageing. Treatment is based on two stem cell-based products we manufacture ourselves from the patient's own tissue: bone marrow concentrate (BMC) and MSC secretome (MSEC). Experimental — fully legal — manufactured under German regulatory authorisation and official inspection since 2018.
MSC secretome (MSEC) is not a stem cell transplant. It is a cell-free preparation containing the molecules released by your own mesenchymal stromal cells isolated from adipose tissue, but no living cells. Bone marrow concentrate (BMC) is cell-containing and concentrated from your own bone marrow. Which of the two is medically appropriate is decided case by case, after diagnostics. Read how ANOVA IRM is regulated, who we are, and what MSC secretome (MSEC) actually is.
Five Programmes at ANOVA
One diagnostic philosophy, applied across five areas of treatment.
| Component | Detail |
|---|---|
| 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 |
Why ANOVA
ANOVA holds manufacturing authorisations under § 13 and § 20c AMG for two stem cell products
Regenerative therapies in Germany are tightly regulated, and ANOVA IRM's two products follow two different legal routes under the German Medicines Act (Arzneimittelgesetz, AMG). Bone marrow concentrate (BMC) requires an authorisation under § 20b AMG for collecting the bone marrow and a manufacturing authorisation (Herstellungserlaubnis) under § 13 AMG [R1–R2]. MSC secretome (MSEC) is a tissue preparation: ANOVA IRM holds an authorisation under § 20b AMG for collecting the tissue and a manufacturing authorisation in the form of an authorisation for processing under § 20c AMG, which requires officially inspected good professional practice (GFP) and compliance with all requirements of the AMG and the German ordinance on the manufacture of medicinal products (AMWHV) for tissue preparations [R2–R3]. 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. These authorisations are issued by the responsible state authority, the Hessian State Office for Health and Care (HLfGP, formerly Darmstadt Regional Council), with the Paul Ehrlich Institute as the competent federal authority for these product classes [R4] — and only after the applicant demonstrates consistent product quality and patient safety.
ANOVA IRM, based in Offenbach am Main, has held these authorisations since 2018 for two products:
- BMC (Bone Marrow Concentrate) — autologous stem cells concentrated from the patient's own bone marrow.
- Mesenchymal Stem Cell Secretome (MSEC) — the totality of substances released by mesenchymal stem cells, including potentially regenerative and anti-inflammatory factors, vesicles and exosomes, produced under controlled laboratory conditions.
These authorisations are a meaningful regulatory distinction, not a formality any medical practice could obtain. For MSEC, ANOVA IRM goes beyond what the law requires: in selected areas — above all production, quality control and quality assurance — it voluntarily applies the stricter standards used for advanced therapy medicinal products. In this way, ANOVA IRM has met since 2018 some of the requirements that the new EU regulation on substances of human origin (SoHO) now sets out — years before that regulation existed.
Providers without such authorisations are not subject to this official control of manufacture and quality. Because ANOVA IRM applies both products only to its own patients and does not place them on the market, no authorisation under § 4b AMG, no marketing authorisation under § 21 AMG and no approval under § 21a AMG is required for administering them [R5, R7, R8].
ANOVA IRM manufactures both products itself. MSC secretome (MSEC) is a cell-free preparation used mainly in chronic conditions, because one tissue collection yields 10 doses that can be stored and given repeatedly. Depending on the condition it is applied intrathecally, into the cerebrospinal fluid, or locally. Bone marrow concentrate (BMC) is cell-containing and is used mainly for acute and locally confined problems, applied — where useful under imaging guidance — directly into the affected joint, tendon or tissue. An overview of both products is available separately.
Why speed matters in modern medicine
Medicine today moves faster than the systems built to regulate and deliver it. New mechanisms of disease, new molecular targets and new regenerative approaches are published every month. The path from a promising finding to a treatment available on prescription is long by design.
This is the gap translational medicine is built to address, and it is why the framework of the individual therapeutic attempt (individueller Heilversuch) exists within German medical practice [R5–R6]: to allow physicians, case by case and under a documented benefit-risk assessment, to offer patients access to well-reasoned, evidence-supported options before those options have completed the full journey to mainstream availability. The individual therapeutic attempt concerns the administration only, not the manufacture of the products.
Diagnosis Before Treatment
We do not treat symptoms with a standard protocol. Every programme begins with a structured diagnostic work-up: imaging, laboratory analysis, and where relevant specialised techniques such as arthro-MRI or non-radioactive contrast MRI. The aim is an exact diagnosis and a clear answer to where and why a treatment could help. Imaging is carried out in the same building, which also allows CT-guided application where the anatomy requires it.
More on diagnostics at ANOVA IRM, including a second opinion on an existing diagnosis and genetic testing.
Put Us to the Test
Get an online or on-site consultation. Bring us your case, your history and your questions. You will receive a diagnostic assessment and a proposed treatment concept, together with the scientific literature it is based on.
How a Case Actually Moves
- Send your request — including relevant medical files.
- Consultation — online or on-site.
- Receive your concept — a diagnostic and treatment plan, with the supporting scientific data.
- Discuss it — with your family and with your own treating physicians.
Contraindications
Our treatments are experimental. We treat only people for whom, after medical assessment, we consider the benefit-risk balance to support treatment.
Applies to all ANOVA treatments:
- Active cancer within the last two years
- Under the age of legal majority
- Pregnancy or breastfeeding
- Active infectious disease (hepatitis A, B, C, HIV, syphilis or other)
Condition-specific exclusion criteria apply in addition and are set out on the relevant page.
What to expect as a patient
- Initial evaluation can begin remotely, by phone or video, without travelling to Germany.
- Offenbach am Main is less than 20 minutes from Frankfurt Airport and reachable by car or train from across Europe.
- Diagnostic imaging (MRI, CT) is available in the same building, often on the same day.
- You send us your case and records, speak with our physicians, and receive a diagnostic and treatment concept together with the underlying scientific literature, so that you and your own doctors can review it.
- Costs depend on the condition and on the product and route of application; indicative figures are given on each condition page. You always receive an individual written cost estimate before any treatment decision. Treatment is generally self-funded.
- All services provided by our patient care team are free of charge; physician consultation fees are stated in advance.
News and insights
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.
General scientific literature
Selected cross-indication literature on mechanism and safety of mesenchymal stromal cells, secretome and extracellular vesicles is maintained on the MSC secretome page; bone marrow literature on the BMC page. Condition-specific studies are cited on the relevant disease pages. The regulatory sources cited on this page are listed in the appendix below.
Appendix — Regulatory sources cited on this page
- R1 § 13 Arzneimittelgesetz (AMG) — Herstellungserlaubnis. Manufacturing authorisation required for the production of medicinal products. https://www.gesetze-im-internet.de/amg_1976/__13.html
- R2 § 20b AMG — Erlaubnis für die Gewinnung von Gewebe und die Laboruntersuchung. https://www.gesetze-im-internet.de/amg_1976/__20b.html
- R3 § 20c AMG — Erlaubnis für die Be- oder Verarbeitung, Konservierung, Prüfung, Lagerung und das Inverkehrbringen von Gewebezubereitungen. https://www.gesetze-im-internet.de/amg_1976/__20c.html
- R4 Paul-Ehrlich-Institut — Arzneimittel für neuartige Therapien (ATMP), Zuständigkeit der Bundesoberbehörde. https://www.pei.de/DE/regulation/genehmigungen/atmp-4b-amg/atmp-4b-amg-node.html
- R5 § 4b AMG — Sondervorschriften für Arzneimittel für neuartige Therapien; Ausnahme vom Vierten Abschnitt (Zulassung). https://www.gesetze-im-internet.de/amg_1976/__4b.html
- R6 World Medical Association, Declaration of Helsinki, Article 37 — Unproven Interventions in Clinical Practice. https://www.wma.net/policies-post/wma-declaration-of-helsinki/
- R7 § 21a AMG — Genehmigung von Gewebezubereitungen. Approval of tissue preparations, required only for placing them on the market. https://www.gesetze-im-internet.de/amg_1976/__21a.html
- R8 § 21 AMG — Zulassungspflicht. Marketing authorisation, required for placing medicinal products on the market. https://www.gesetze-im-internet.de/amg_1976/__21.html
