Stem Cell Therapy for Neurodegenerative Disease · ANOVA Germany

The ANOVA Stem Cell ALS Programme

An individualised programme combining mesenchymal stromal cell secretome therapy with supportive components, for people living with amyotrophic lateral sclerosis.

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Layer 1 · Read in under 2 minutes

Introduction & Summary

What the programme is, its five components, and who it is for — the essentials at a glance.

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Layer 2 · Practical & Logistics

Treatment, Eligibility & Cost

Who qualifies, what the process actually involves, and what it costs — step by step.

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Layer 3 · Full clinical detail

Clinical & Scientific Evidence

ALS biology, the rationale behind each component, our real-world data and all references.

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Portrait of Prof. Dr. Michael K. Stehling
Written by

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

University Professor of Radiology, Jerusalem University (AQU), Fmr. Fellow, Harvard Medical School, Boston, Assoc. Prof. of Radiology, Boston University, Visiting Scholar, UCLA Berkeley, Founder, CEO, Medical Director ANOVA IRM GmbH

Prof. Stehling is a physicist, physician and inventor. He was involved in the development of Magnetic Resonance Imaging (MRI) with Nobel laureate Sir Peter Mansfield, the development of the E² tumour ablation technique with Boris Rubinsky and serves as Chief Medical Officer for BioChoric Inc., the company developing isochoric cryopreservation. He pioneered irreversible electroporation (IRE) for prostate cancer and has established the first German facility licensed to manufacture two stem cell products for the treatment of patients.

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Introduction & Summary

 

The ANOVA ALS Stem Cell Programme

ANOVA IRM offers an individualised, multi-component treatment programme for people with amyotrophic lateral sclerosis (ALS), centred on mesenchymal stromal cell secretome (MSEC) therapy, delivered under German medical licence in Offenbach, Germany. The programme is experimental — not a cure — and is offered alongside, not instead of, standard ALS care such as riluzole.

Unlike approaches involving living stem cell transplants, MSEC is a cell-free preparation containing biologically active molecules released by the patient's own mesenchymal stromal cells. On this page we discuss the current state of ALS treatment and the scientific basis for our approach. For people with ALS and their caregivers considering experimental options, we present our clinical observations and explain how suitable patients are evaluated and treated at our institute in Offenbach, Germany.

Why ANOVA

ANOVA IRM is fully legal and one of the few institutions in Germany — and the only one holding manufacturing authorisation for two distinct stem cell-based products, BMC and MSC secretome — licensed to produce and administer these therapies under German and European regulatory oversight (Regierungspräsidium Hessen & Paul-Ehrlich-Institut).

To date, more than 75 people with ALS have been treated at our institute. Every treatment decision is made individually, following comprehensive neurological assessment and full discussion of the current evidence with the patient.

ALS is one of several neurodegenerative and neurological conditions we treat using the same individualised, evidence-informed approach — including multiple sclerosis, Parkinson's disease, and stroke recovery.

Understanding ALS, briefly

ALS, also called motor neuron disease or Lou Gherig´s disease, is a progressive disease of the motor neurons that control voluntary movement. As these neurons degenerate, muscles weaken over time, affecting mobility, speech, swallowing and breathing. Most cases occur without a known family history. The underlying biology involves several interacting processes — including inflammation, cellular ageing, and impaired neuron support — rather than a single cause.

This is why ANOVA's approach does not rely on a single intervention, but addresses several of these processes together.

The ANOVA ALS Programme — Five Components

01

Mesenchymal Stromal Cell Secretome

MSEC, the biologically active molecules naturally released by stem cells — administered directly into the cerebrospinal fluid, where research suggests they may support neuronal survival and reduce inflammation.

02

TUDCA (Tauroursodeoxycholic Acid)

A naturally occurring compound under active clinical investigation for its potential to protect motor neurons and support cell function.

03

Senolytic Therapy

Targets senescent ("aged") cells, which are increasingly understood to contribute to chronic inflammation in neurodegenerative disease.

04

Gut Microbiome Analysis & Substitution

Assessment of the gut-brain axis, with personalised dietary and probiotic strategies where clinically indicated.

05

HAL Robotic Exoskeleton Training (optional, where appropriate)

A voluntary-driven robotic leg exoskeleton (Hybrid Assistive Limb) that may help preserve walking ability in patients who retain sufficient residual muscle activity. Offered as an adjunct for suitable candidates, not as a substitute for the therapies above.

Each component is selected individually based on the patient's clinical picture — not applied as a fixed package.

→ Full scientific rationale and literature references for every component: see Layer 3 — Clinical & Scientific Evidence.

Early Research Data

In 69 ALS patients with sufficient follow-up (of 86 treated since 2016), MSEC was linked to ~30% slower functional decline than typical for no treatment, and ~23% slower than typical for riluzole — an early signal, not yet proven. Real patient data; not yet statistically significant.

→ Read the full Research Update, including every limitation of this data and how it compares to riluzole's evidence base: see Clinical & Scientific Evidence.

ALSFRS-R chart showing numerically slower progression in 69 MSEC-treated ALS patients compared with literature reference slopes for riluzole and no treatment over 24 months.
ANOVA MSEC patients' ALSFRS-R decline vs. typical riluzole and no-treatment reference rates, 0–24 months.

Who this programme is for

We treat patients in the early to mid stage of ALS who can breathe unassisted (normal respiratory function). A full clinical evaluation — including medical history, neurological status and, where relevant, genetic or microbiome testing — precedes every treatment recommendation.

→ Full eligibility criteria, requirements, contraindications, testing, treatment schedule and cost: see Treatment, Eligibility & Cost.

What to expect

Initial evaluation can begin remotely, by phone or video consultation, without travel to Germany. Treatment itself requires an in-person visit to Offenbach (near Frankfurt am Main). We will provide a personalised cost estimate before any treatment decision is made.

Quick answers

Can stem cell therapy cure ALS?

No. No stem-cell-based treatment has been shown to cure ALS or restore motor neurons that have already been lost. ANOVA's programme is investigated for its potential to slow decline and support remaining neurons — not as a cure.

Is MSEC an approved treatment for ALS?

No. It is offered under the German legal framework for an individual therapeutic attempt ("individueller Heilversuch"), following full disclosure of its experimental nature and informed consent. Full legal and regulatory detail is on the Clinical & Scientific Evidence page.

How much does treatment cost?

Approximately €20,000–€36,000 depending on the number of doses used. Full cost breakdown and payment details are on the Treatment, Eligibility & Cost page.

Should I stop my current ALS medication (e.g. riluzole)?

No. ANOVA's programme is intended to complement, not replace, guideline-based ALS care. Please continue to work with your treating neurologist throughout.

Explore our other programmes

ANOVA IRM treats several neurodegenerative and neurological conditions using the same individualised approach described on this page.

Multiple Sclerosis → Parkinson's Disease → Stroke Recovery →

Next steps

Layer 1 · Read in under 2 minutes

Introduction & Summary

What the programme is, its five components, and who it is for — the essentials at a glance.

Jump to section
Layer 2 · Practical & Logistics

Treatment, Eligibility & Cost

Who qualifies, what the process actually involves, and what it costs — step by step.

Jump to section
Layer 3 · Full clinical detail

Clinical & Scientific Evidence

ALS biology, the rationale behind each component, our real-world data and all references.

Jump to section

ALS Treatment: Eligibility, Process & Cost

Who qualifies for MSEC treatment, what the process actually involves, and what it costs — explained step by step.

MSEC treatment for ALS at ANOVA IRM costs approximately €20,000–€36,000 depending on the number of doses, requires a two-day outpatient visit to Offenbach for tissue collection, and is generally available to patients with early-to-mid stage ALS who can breathe unassisted. This page explains eligibility, the full process, and costs in detail.

Request a Cost Estimate →

Mesenchymal stromal cells releasing extracellular vesicles, miRNA, proteins and cytokines investigated in cell-free mesenchymal stem cell therapy.
MSC secretome components and cellular signalling.

The timeline at a glance

  1. 01
    Initial evaluation

    Remote, by phone/video — typically 2 weeks to a few months depending on availability

  2. 02
    Testing & screening

    Bloodwork and infectious-disease screening; can begin in home country, confirmed/repeated in Offenbach

  3. 03
    First visit (tissue harvest)

    2-day outpatient visit to Offenbach; mini-liposuction under brief sedation

  4. 04
    Production & quality control

    Approximately 4 weeks; yields 10 or 20 doses per cycle

  5. 05
    Storage

    Up to 2 years — allows an extended, personalised application schedule

  6. 06
    Application schedule

    Intrathecal injection every 4–6 weeks (single dose), or — more commonly — double dose every 3 months

  7. €
    Cost

    Approximately €20,000–€36,000, depending on number of doses used out for 10 produced

Who qualifies -requirements

We treat patients in the early to mid stage of ALS who can breathe unassisted (normal respiratory function) and are medically fit for the brief sedation needed to harvest fat tissue. ANOVA treats fast and slow progressors. After review of your medical data including diagnosis and neurological assessment etc. a full clinical evaluation — including medical history, neurological status and, where relevant, genetic or microbiome testing — precedes every treatment recommendation. We cannot treat children or pregnant women; other factors may also be exclusion criteria. Any special requirements are discussed with you.

Contraindications

Our stem cell treatments are experimental. We only treat patients for whom we believe the risk/benefit ratio indicates treatment, based on current medical and scientific evidence. We do not treat patients for whom the following apply:

  • Active cancer in the last two years
  • Not yet of legal age
  • Existing pregnancy or lactation period
  • Unable to breathe on own, ventilator
  • Difficulty breathing in supine position
  • Dysphagia (extreme difficulty swallowing)
  • Psychiatric disorder
  • Active infectious disease (Hepatitis A, B, C, HIV, Syphilis, or other)

Testing & screening

Patients who appear suitable are asked to complete preliminary testing in their home country — typically bloodwork to identify medical or infectious-disease factors that could prevent treatment. If no exclusion criteria are diagnosed, the patient can proceed with the planned visit to Offenbach. Required testing is confirmed or repeated at ANOVA IRM before adipose tissue is harvested, so the examination in Offenbach primarily confirms the earlier review rather than starting the process from scratch.

First visit to Offenbach

The first treatment visit requires approximately two days in Offenbach, on an outpatient basis. A small amount of adipose tissue is collected by mini-liposuction under brief sedation. The total timeline from this point to the first secretome application is usually 4-6 weeks.

Production

Mesenchymal stromal cells are isolated from the harvested tissue and expanded under controlled laboratory conditions in our GMP/GFP facility in Offenbach Germany. Then tell stem cells are used to produce the patient's MSEC preparation — the biologically active factors released by the cells, not the living cells themselves. Production and quality control take approximately four weeks and typically yield 10 doses per cycle. The resulting secretome can be stored for up to two years, allowing an extended, personalised application schedule.

Treatment schedule, timeline and intervals

Once production and quality control are complete, patients return to Offenbach for their MSEC applications. For ALS, the secretome is administered intrathecally by lumbar puncture into the cerebrospinal fluid, typically every 4 to 6 weeks as a single dose, or — more commonly — as a double dose every 3 months. The treating physician recommends an appropriate schedule according to medical needs and travel readiness, and patients decide whether and when to return for subsequent applications within the two-year storage period.

Cost & cost estimates

Treatment cost depends on the product used, the number of doses, further examinations, and sedation/anaesthesia preferences. MSEC treatment generally costs approximately €20,000 to €36,000, depending on the total number of doses used out of the 10 produced. Additional programme components, diagnostics, sedation and the individual application schedule may affect the total cost. You will receive an individualised written cost estimate before any treatment decision is made. Travel, accommodation and other personal expenses are separate.

Does health insurance cover the cost?

Experimental ALS treatment is generally self-funded. Patients may check possible reimbursement with their insurer individually, but should expect to cover treatment costs themselves.

Frequently asked questions

Who qualifies for ALS stem cell therapy at ANOVA IRM?

Patients with confirmed early- to mid-stage diagnosis of ALS/MND who can breathe independently and are medically fit for the brief sedation and tissue-harvesting procedure required for MSEC production. Final eligibility is determined through individual medical assessment; see the full contraindication list on this page.

How is MSEC administered for ALS?

By intrathecal injection via lumbar puncture into the cerebrospinal fluid, typically at 4 to 6 weeks intervals as a single dose, or — more commonly — a double dose every 3 months, according to the individual treatment plan. This would allow for a treatment timeline of 5 visits over 1 year.

How long does the whole process take?

Initial evaluation can begin remotely and may take from approximately two weeks to several months. Tissue harvesting requires about two days in Offenbach, followed by approximately four weeks of production and quality control. Patients then return for applications according to their individual schedule.

How much does ALS stem cell treatment cost?

MSEC treatment generally costs approximately €20,000 to €36,000, depending on the total number of doses used. ANOVA provides an individualised written estimate before treatment; travel and accommodation are separate.

Does health insurance cover ALS stem cell therapy?

Experimental ALS treatment is generally self-funded. Patients may check possible reimbursement with their insurer individually, but should expect to cover treatment costs themselves.

Should patients continue their existing ALS treatment (e.g. riluzole)?

Yes. ANOVA's programme is intended to complement rather than replace established neurological care. Patients should continue to discuss guideline-based ALS treatment and ongoing care with their treating neurologist.

Layer 1 · Read in under 2 minutes

Introduction & Summary

What the programme is, its five components, and who it is for — the essentials at a glance.

Jump to section
Layer 2 · Practical & Logistics

Treatment, Eligibility & Cost

Who qualifies, what the process actually involves, and what it costs — step by step.

Jump to section
Layer 3 · Full clinical detail

Clinical & Scientific Evidence

ALS biology, the rationale behind each component, our real-world data and all references.

You are here

ALS: Clinical & Scientific Evidence

The biology of ALS, the mechanism behind each programme component, and an honest account of where our real-world evidence currently stands.

Discuss the Evidence With a Neurologist →

This page sets out the biology of ALS, the current guideline-based standard of care, the legal framework under which ANOVA's programme is offered, the scientific rationale for each programme component with literature references, and ANOVA's own real-world outcome data — including its limitations, reported without embellishment.

1. Understanding ALS/MND

Amyotrophic lateral sclerosis (ALS), also known as motor neuron disease (MND) or Lou Gehrig's disease, is a progressive neurodegenerative disorder affecting the nerve cells that control voluntary movement.[23] As upper and lower motor neurons gradually degenerate, muscles become weaker, leading over time to increasing difficulties with mobility, speech, swallowing and breathing.[23]

ALS affects approximately 5 people per 100,000 worldwide.[23] Around 90% of cases occur without a known family history (sporadic ALS), while approximately 10% represent familial ALS associated with inherited genetic variants, including mutations in genes such as SOD1, C9orf72, TARDBP and FUS.[22]

Although the exact causes of ALS remain incompletely understood, extensive research indicates that several biological processes contribute to disease progression, including neuroinflammation, oxidative stress, mitochondrial dysfunction, impaired protein homeostasis, disturbances in cellular energy metabolism and alterations of the gut–brain axis.[14],[17] Rather than representing a single disease mechanism, ALS is now widely regarded as a complex disorder involving multiple interacting pathways.[22]

Healthy motor neuron compared with nerve cells affected by amyotrophic lateral sclerosis, also called Lou Gehrig's disease, showing reduced neuromuscular connections and muscle atrophy.
Motor neuron degeneration and muscle atrophy in ALS.

2. Current Standard of Care

International treatment guidelines recommend multidisciplinary care combined with approved pharmacological therapies where appropriate. Comprehensive supportive care — physiotherapy, nutritional support, respiratory care, speech and language therapy, and assistive technologies — remains an essential component of ALS management throughout the course of the disease.[23]

Riluzole has been the standard pharmacological treatment for ALS for almost three decades. Clinical studies show the medication can modestly prolong survival in some patients, though the magnitude of benefit varies between individuals.[1],[2],[3] Like all medicines, riluzole may also cause adverse effects, including gastrointestinal symptoms and elevations of liver enzymes.[1]

Edaravone has been approved in several countries for selected ALS patients following studies suggesting a reduction in functional decline in certain populations, though the extent to which these findings generalise to the broader ALS population continues to be investigated.[21] Sodium phenylbutyrate combined with taurursodiol (TUDCA) is another approach that generated encouraging early results, prompting further confirmatory research into its long-term clinical benefit.[10]

Important: this is the guideline-based standard of care. ANOVA IRM's programme, described below, is offered alongside — not in place of — these therapies, and treatment recommendations are developed individually rather than according to a fixed protocol.

ANOVA IRM holds GMP/GFP legal permissions and is controlled by the German FDA equivalent (HlfGP and PEI). Where medically appropriate, treatment at ANOVA IRM may be offered within the German legal framework of an individual therapeutic attempt ("individueller Heilversuch"). This framework allows physicians, in carefully selected individual cases, to consider treatment approaches that are not part of established standard therapy — provided that patients receive comprehensive medical information, understand the experimental nature of the intervention, and provide informed consent.

The therapeutic approaches described on this page are therefore not established standard treatments for ALS/MND. Several components are currently being investigated in clinical research; others are supported primarily by preclinical studies and translational scientific evidence. Their potential benefits and risks are discussed individually with each patient before any treatment decision is made.

Manufacturing authorisation: Regierungspräsidium Hessen & Paul-Ehrlich-Institut. Information correct as of 2026.

4. Component-by-Component Scientific Rationale

To date, more than 70 individuals with ALS have been treated at our institute. Rather than focusing on a single biological pathway, our therapeutic strategy addresses several mechanisms believed to contribute to ALS progression: neuroinflammation, impaired neuronal support, cellular ageing, and disturbances of the gut-brain axis.

01

Mesenchymal Stromal Cell Secretome (MSEC

This approach uses MSEC the broad spectrum of biologically active molecules naturally released by MSCs — growth factors, cytokines, extracellular vesicles, exosomes and other signalling molecules — rather than transplanting living cells.[8],[9] Experimental studies suggest these substances may influence inflammatory processes, support neuronal survival and promote tissue repair. Early clinical studies of MSC-derived products administered intrathecally have shown encouraging safety data and biological activity, though clinical efficacy remains under investigation.[6],[7] At ANOVA IRM, the secretome is administered by lumbar puncture into the cerebrospinal fluid, intended to give the central nervous system direct exposure to its biologically active components.

02

Tauroursodeoxycholic Acid (TUDCA)

A naturally occurring bile acid of considerable scientific interest for its potential neuroprotective properties.[10] Laboratory studies suggest TUDCA may influence mitochondrial function, endoplasmic reticulum stress and apoptosis. Early clinical studies in ALS reported encouraging findings, leading to larger international trials now evaluating its therapeutic role.[11],[12] TUDCA is not an approved ALS treatment, and its role remains investigational.

03

Gut Microbiome Analysis & Substitution

Growing evidence points to a gut-brain axis that may influence immune regulation and neurological health.[13],[14] Several studies report differences in gut microbiome composition between ALS patients and healthy individuals; clinical significance remains under investigation, but the observations have driven research interest in the microbiome's role in neuroinflammation.[15],[16],[17] ANOVA IRM offers comprehensive microbiome analysis as part of individual clinical assessment, which may inform personalised dietary or probiotic strategies.

04

Cellular Senescence and Senolytic Therapies

Biological ageing is increasingly recognised as relevant to ALS.[19] Senescent cells stop dividing but continue releasing inflammatory signalling molecules, and their accumulation may contribute to chronic inflammation and impaired tissue repair.[19],[20] In animal models and early translational research, senolytic compounds have selectively reduced senescent cell populations and influenced biological markers of neurodegeneration; clinical research in human neurodegenerative disease is ongoing.[18] No senolytic compound is established or approved as an ALS treatment.

05

HAL Robotic Exoskeleton Training (optional adjunct)

The Hybrid Assistive Limb (HAL), developed by Cyberdyne Inc. (Japan), is a voluntary-driven robotic exoskeleton that detects residual bioelectrical signals from the patient's own muscles and assists the intended movement. A multicentre, randomised, controlled crossover trial across nine Japanese hospitals found that HAL-based cybernic treatment significantly improved ambulatory function in patients with slowly progressive rare neuromuscular diseases, a category that includes ALS.[24] In an ALS/MND-specific study, a full course of HAL training produced a significant improvement in gait cadence on the 10-metre walk test, although overall gait speed and step length were not significantly affected in that cohort.[25] Supporting evidence from a related progressive neuromuscular condition — limb-girdle muscular dystrophy — found HAL-supported treadmill therapy to be safe and feasible.[26]

HAL training is offered at ANOVA IRM as an optional adjunct for ambulatory patients who retain residual muscle activity for the device to detect and assist — it is not part of the core pharmacological/biological programme, and is not appropriate for all patients.

→ Eligibility criteria, treatment schedule and cost for all programme components: see Treatment, Eligibility & Cost.

5. Real-World Data — MSEC for ALS: Where Our Research Stands

Research Update, August 2026

We have early, encouraging signals from our ongoing work with mesenchymal stem cell secretome (MSEC) in ALS — and we want to be direct about what that does and doesn't mean yet.

What we're studying

Since 2016, we have to date treated 86 people with a diagnosis of ALS/MND with MSEC and tracked their functional ability over time using the ALSFRS-R, the standard 48-point scale used in ALS research and care.

The early trend

Looking at the 69 patients with enough follow-up data, people in our MSEC cohort lost function more slowly, on average, than what's typically reported for people with no treatment, and somewhat more slowly than what's typically reported for people on riluzole.

ALSFRS-R decline of ANOVA MSEC patients compared with riluzole and no-treatment reference rates
The blue line and dots show the real, monthly-averaged functional scores of our MSEC patients, with the shaded band showing patient variation. The dotted blue line is a straight-line trend (−0.697 points/month) fitted through that data, shown for direct comparison with two reference lines: red for the typical pace of decline with no treatment (−1.0 points/month), and green for the typical pace of decline reported with riluzole (−0.9 points/month). All three lines are estimates, not guarantees for any individual patient.
~30%

Slower average decline vs. no treatment (not yet statistically significant)

~23%

Slower average decline vs. riluzole (not yet statistically significant)

69

Patients with enough follow-up to analyse, of 86 treated

The encouraging part: the direction of the trend is consistent whether we look at the full follow-up period or just the first nine months, which is the timeframe most ALS case studies use. That consistency is a reasonable basis to keep investigating this approach seriously.

What this doesn't yet tell us

We want to be direct about the limits of this data, because we think that's what honest medicine looks like — especially for a disease where people are making real decisions under real pressure.

  • It is not yet statistically significant. With the number of patients we have so far, we cannot rule out that this trend is due to chance. A larger study is needed to know for sure.
  • There is no comparison group. Everyone in this analysis received MSEC. We are comparing our patients to published rates from other studies, not to a matched group of ALS patients who didn't receive treatment — a much weaker form of evidence than a controlled trial.
  • Our patients may not be a typical group. People who return for repeated treatments and follow-up visits over months or years tend to be doing relatively well. That alone could make our results look better than the treatment's true effect.
  • ALS varies enormously between people, which makes small studies like this one hard to interpret with confidence.

How this compares to riluzole

We know many patients and clinicians are frustrated with riluzole — its benefit is real but modest, and it comes with side effects. That frustration is completely understandable, and it's part of why we're pursuing MSEC research in the first place.

To be fair to the comparison: riluzole's approval and status as standard of care rest on large controlled trials and real-world data showing a statistically significant survival benefit, along with decades of safety experience. Its benefit on day-to-day function is more modest and has been harder to demonstrate consistently — but its core evidence base is substantially stronger than what we have for MSEC today. We think it's important to say that plainly rather than imply the two are on equal footing at this stage.

What comes next

These early results are encouraging, but they're not a conclusion. As a private treatment centre, ANOVA is not in a position to sponsor a formal randomised clinical trial. What we are committed to is continuing to treat patients individually, collecting data on every person we treat, and evaluating that data — rigorously and transparently, including its limitations — against the growing body of published research from other centres and registries, as our numbers grow.

Stay informed. If you or a loved one has ALS and you'd like to be kept informed as our data develops and is published, please contact ANOVA IRM. This is not a treatment referral — it's an invitation to follow our research as it grows.

Important: MSEC is an investigational, autologous cell-secretome preparation. It is not an FDA-approved treatment for ALS/MND. Nothing on this page is medical advice. Please talk to your neurologist about your individual treatment options, including riluzole, edaravone, AMX0035, and tofersen where applicable.

6. Frequently Asked Questions — Evidence & Approval Status

Can stem cell therapy help ALS?

Stem cell-based therapies for ALS remain experimental. Current research is focused mainly on whether these approaches may support remaining motor neurons and potentially slow disease progression by influencing biological processes involved in ALS. ANOVA IRM uses a cell-free MSEC preparation derived from the patient's own mesenchymal stromal cells; the rationale and our own clinical observations are set out above.

Is stem cell therapy approved for ALS?

Stem cell therapy is not an established standard treatment for ALS/MND in Germany or the EU. In South Korea, NeuroNata-R (lenzumestrocel), an autologous bone-marrow-derived MSC treatment, received conditional approval for ALS in 2013/2014. Its confirmatory, randomized Phase 3 trial (ALSUMMIT) did not reach statistical significance across the full study population, but did show a benefit in a subgroup of slower-progressing patients; based on that data, South Korea's Ministry of Food and Drug Safety updated the product's label and retained its conditional approval in 2026. NeuroNata-R contains living MSCs and is therefore distinct from ANOVA's cell-free MSEC approach, which is offered as an experimental treatment following individual medical assessment and informed consent.

Can stem cell therapy cure ALS?

No stem-cell-based treatment has been shown to cure ALS or restore motor neurons that have already been lost. Current approaches, including ANOVA's, are being investigated for their potential neuroprotective and supportive effects only.

What type of stem cell therapy does ANOVA use for ALS?

ANOVA primarily uses an autologous Mesenchymal Stromal Cell Secretome (MSEC) produced from the patient's own mesenchymal stromal cells. The final preparation is cell-free and contains the biologically active factors released by these cells rather than living MSCs.

9. Scientific References — ALS-Specific Literature

Current Standard Therapy for ALS

  1. Bensimon G, Lacomblez L, Meininger V. A Controlled Trial of Riluzole in Amyotrophic Lateral Sclerosis. NEJM. 1994;330:585–591.
  2. Miller RG, Mitchell JD, Moore DH. Riluzole for ALS/MND. Cochrane Database Syst Rev. 2012;(3).
  3. Fang T, et al. Riluzole, Disease Stage and Survival in ALS. Lancet Neurology. 2018;17:416–418.
  4. Andrews JA, et al. Real-world Evidence of Riluzole Effectiveness in ALS. ALS Frontotemporal Degener. 2020;21:509–518.
  5. Thakore NJ, et al. Early Initiation of Riluzole May Improve Absolute Survival in ALS. Muscle & Nerve. 2023;67:146–154.

Mesenchymal Stromal Cells and Regenerative Medicine

  1. Oh KW, et al. Phase I Trial of Repeated Intrathecal Autologous BM-MSCs in ALS. Stem Cells Transl Med. 2015;4:590–597.
  2. Petrou P, et al. Safety and Clinical Effects of MSCs Secreting Neurotrophic Factor in ALS. JAMA Neurology. 2016;73:337–344.
  3. Mazzini L, et al. MSC Transplantation in ALS: A Review of Clinical Studies. J Neurol. 2019.
  4. Deng S, Xie H, Xie B. Cell-Based Regenerative Strategies for Neurodegenerative Diseases. Stem Cell Res Ther. 2025.

TUDCA and Neuroprotection

  1. Cudkowicz ME, et al. Trial of Sodium Phenylbutyrate–Taurursodiol for ALS. NEJM. 2022.
  2. Albanese A, et al. TUDCA in ALS: The TUDCA-ALS Trial Protocol. Front Neurol. 2022;13:1009113.
  3. Lombardo FL, et al. Safety and Efficacy of TUDCA as Add-On Treatment in ALS: SAP. Trials. 2023;24:792.

HAL Robotic Exoskeleton Training

  1. Nakajima T, Sankai Y, Takata S, et al. Cybernic treatment with wearable cyborg Hybrid Assistive Limb (HAL) improves ambulatory function in patients with slowly progressive rare neuromuscular diseases: a multicentre, randomised, controlled crossover trial for efficacy and safety (NCY-3001). Orphanet J Rare Dis. 2021;16(1):304. PMID: 34233722.
  2. Morioka H, Hirayama T, Sugisawa T, et al. Robot-assisted training using hybrid assistive limb ameliorates gait ability in patients with amyotrophic lateral sclerosis. J Clin Neurosci. 2022;99:158–163. PMID: 35279589.
  3. Sczesny-Kaiser M, Kowalewski R, Schildhauer TA, et al. Treadmill training with HAL exoskeleton — a novel approach for symptomatic therapy in patients with limb-girdle muscular dystrophy — preliminary study. Front Neurosci. 2017;11:449. PMID: 28848377.

Gut–Brain Axis and the ALS Microbiome

  1. Cryan JF, et al. The Microbiota–Gut–Brain Axis. Physiol Rev. 2019.
  2. Cryan JF, O'Riordan KJ, Cowan CSM, et al. The Microbiota-Gut-Brain Axis. Lancet Neurol. 2020;19:179–194.
  3. Dandamudi S, et al. Neurodegenerative Disorders and the Gut–Microbiome–Brain Axis: A Review. Cureus. 2024.
  4. Li X, et al. Correlation Between the Gut Microbiome and Neurodegenerative Diseases. Neural Regen Res. 2024;19:833–845.
  5. Yang EJ. The Emerging Role of the Brain–Gut Axis in ALS. Int J Mol Sci. 2025.

Cellular Senescence and Healthy Ageing

  1. Gonzales MM, et al. Senolytic Therapy in Mild Alzheimer's Disease: A Phase I Trial. Nat Med. 2023;29:2481–2488.
  2. Tan X, Gao N. The Emerging Role of Cellular Senescence in ALS. Front Neurosci. 2025.
  3. Tsang VSK, Malaspina A, Henson SM. The Metabolic Intersection Between Immunosenescence and Neuroinflammation in ALS. J Inflamm. 2025.

Translational Medicine and Emerging Therapeutic Concepts

  1. Bedlack RS. The Scientific and Therapeutic Rationale for Off-Label Treatments in ALS. Ann Neurol. 2025.
  2. Mejzini R, et al. ALS Genetics, Mechanisms and Therapeutics: Where Are We Now? Front Neurosci. 2019.
  3. van Es MA, Hardiman O, Chio A, et al. Amyotrophic Lateral Sclerosis. The Lancet. 2017;390:2084–2098.

→ View supporting MSC / exosome / regenerative medicine literature in the ANOVA Scientific Library — general mechanism references shared across all five programme pages, kept off this page since they are not ALS-specific.

  1. Georg Hansmann, Philippe Chouvarine, Franziska Diekmann, Martin Giera, Markus Ralser, Michael Mülleder, Constantin von Kaisenberg, Harald Bertram, Ekaterina Legchenko & Ralf Hass "Human umbilical cord mesenchymal stem cell-derived treatment of severe pulmonary arterial hypertension". Nature Cardiovascular Research volume 1, pages568–576 (2022).
  2. Murphy JM, Fink DJ, Hunziker EB, et al. Stem cell therapy in a caprine model of osteoarthritis . Arthritis Rheum. 2003;48:3464–74.
  3. Lee KB, Hui JH, Song IC, Ardany L, et al. Injectable mesenchymal stem cell therapy for large cartilage defects—a porcine model. Stem Cell. 2007;25:2964–71.
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Contraindications

Our stem cell treatments are experimental, but we only treat patients for whom we believe the risk/benefit ratio indicates treatment based on the state of the art, i.e., medical, scientific evidence.

Please understand that we therefore do not treat patients for whom the following points apply:

  • Active cancer in the last two years
  • Not yet of legal age
  • Existing pregnancy or lactation period
  • Unable to breathe on own, ventilator
  • Difficulty breathing in supine position
  • Dysphagia (extreme difficulty swallowing)
  • Psychiatric disorder
  • Active infectious disease (Hepatitis A, B, C, HIV, Syphilis, or other)