Neurodegenerative Diseases and Stem Cell Therapy Germany

Neurodegenerative diseases are among the most complex conditions in modern medicine. They involve the gradual breakdown of the brain, spinal cord, or nervous system, which over time affects movement, coordination, and overall neurological function. Dr. mult. Stehling and ANOVA IRM have treated 188 people with neurological and neurodegenerative diseases since 2016 (as of October 2026).

For many of these conditions, treatment options are limited. Most therapies are designed to manage symptoms rather than influence the underlying biological processes driving disease progression.

Stem cell treatment for neurodegenerative diseases is not a cure. It is intended to help support neurological function, although outcomes vary depending on the condition and stage. These therapies aim to influence processes like inflammation and neuronal cell death within the central nervous system.

At ANOVA Institute for Regenerative Medicine (ANOVA IRM), treatment is focused on specific neurodegenerative conditions where stem cell-based therapies can be applied as part of a medically guided approach. It is offered alongside — never instead of — the treatment by your neurologist.

In neurodegenerative diseases, nerve cells in the brain and spinal cord are gradually lost, so that movement, sensation, speech or thinking are increasingly affected. ALS, Parkinson’s disease and progressive forms of multiple sclerosis are examples; a stroke damages nerve cells suddenly, but its consequences can persist. Disorders of the nervous system as a whole affected about 3.4 billion people worldwide in 2021.^[1]

Typical complaints, depending on the disease, are:

• Muscle weakness and wasting, as in ALS
• Tremor, stiffness and slowed movement, as in Parkinson’s disease
• Numbness, visual disturbances and fatigue, as in multiple sclerosis
• Paralysis or speech problems after a stroke

Most of these diseases progress over time. To date no cure is known for most neurodegenerative diseases. More details can be found below in our scientific section on neurodegenerative diseases.

ANOVA IRM focuses on neurodegenerative diseases where neuronal damage, inflammation, and disrupted neurological function play a central role in disease progression.

While these conditions differ in cause and presentation, they share underlying biological processes that are the focus of research into the neuroprotective and immunomodulatory stem cell-based approaches used at our centre.

Amyotrophic Lateral Sclerosis (ALS)

Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease involving the loss of motor neurons in the brain and spinal cord. As these neurons degenerate, patients experience muscle weakness, atrophy, and loss of voluntary movement.

At a cellular level, ALS involves neuronal damage, inflammatory signalling, and dysfunction in surrounding support cells. Research approaches are therefore focused on protecting remaining neurons and supporting neurological function.

At ANOVA IRM, stem cell-based therapies for ALS are applied with the aim of addressing neuroprotection and the environment surrounding affected neurons.

Learn more about ALS stem cell treatment →

Parkinson’s Disease (PD)

Parkinson’s disease develops through the gradual loss of dopamine-producing neurons in areas of the brain responsible for movement control. As this process progresses, symptoms such as tremor, rigidity, and slowed movement emerge.

Unlike conditions driven by a single pathway, Parkinson’s involves ongoing degeneration and broader dysfunction within the neural environment. This makes treatment less about reversal and more about maintaining function and stability over time.

At ANOVA IRM, stem cell-based therapies for Parkinson’s disease are applied with the aim of addressing dopaminergic neuron function and neural signalling involved in movement control.

Learn more about Parkinson’s disease stem cell treatment →

Multiple Sclerosis (MS)

Multiple sclerosis (MS) is an autoimmune condition in which the immune system attacks the myelin sheath that insulates nerve fibres. As this layer breaks down, communication between the brain and body becomes disrupted.

Unlike ALS and Parkinson’s, MS is primarily driven by immune-mediated inflammation, which also leads to long-term neurological damage. MS is therefore also part of our autoimmune diseases programme.

At ANOVA IRM, stem cell-based therapies for multiple sclerosis are applied with the aim of addressing immune activity and nerve signalling pathways.

Learn more about multiple sclerosis stem cell treatment →

Stroke

A stroke interrupts the blood flow to part of the brain, so that nerve and support cells in the affected region die within minutes. Movement, sensation, speech or thinking can be affected, and stroke is a leading cause of disability worldwide.^[6] A stroke is not a neurodegenerative disease, but inflammation after the event can contribute to further damage.

At ANOVA IRM, MSEC is given into the cerebrospinal fluid after a stroke, with the aim of influencing this inflammation and the environment of the affected nerve cells.

Learn more about stem cell treatment after a stroke →

ANOVA offers a programme for neurological and neurodegenerative diseases, alongside their established treatment. Its core is autologous mesenchymal stem cell secretome (MSEC), given into the cerebrospinal fluid; depending on the disease, further components are added. Each component is selected individually; the programme is not a fixed package.

Stem cells are thought to act mainly through soluble factors, together called the secretome. In neurodegenerative diseases, inflammation within the nervous system and the loss of nerve cells reinforce each other. MSEC is intended to potentially influence this inflammatory activity and the environment of the remaining nerve cells.

ANOVA IRM has not yet tested MSEC in a clinical study. The current state of research is described in the clinical and scientific section below.

An MRI of the brain and spinal cord helps to exclude other causes of the symptoms and, in MS, shows which lesions are active. Before MSEC, an MRI of the abdominal wall is also needed to exclude a hernia before the fat collection.

MSEC is the cell-free mixture of signalling molecules, including exosomes, released by your own mesenchymal stromal cells from fat tissue. The fat is collected in a mini-liposuction under brief sedation. MSEC is given into the cerebrospinal fluid (intrathecally); one production yields 10 doses for a longer treatment period. Small external phase 1/2 studies with related MSC products are summarised in the clinical and scientific section below.

Depending on the disease, the programme can include TUDCA, prescribed individually as a pharmacy-compounded preparation (Rezepturarzneimittel), senolytic therapy, gut microbiome analysis and, optionally, HAL robotic exoskeleton training. We do not name individual senolytic substances on this website. Each component is described, with its evidence, on our pages for ALS, Parkinson’s disease and multiple sclerosis.

Neurological diseases can look alike, so we first review how far the disease has progressed and where. Dr. Stehling, founder of ANOVA IRM, is a radiologist and physicist. We work with the Prof. Dr. Stehling Institut für Bildgebende Diagnostik GmbH, which, like ANOVA IRM, belongs to Dr. Stehling and is located in the same building.

Which tests are used to diagnose neurodegenerative diseases?

The diagnosis is made by your neurologist from the medical history, the neurological examination and further tests. MRI of the brain and spinal cord is central in MS and after a stroke. In ALS, nerve conduction studies and electromyography are used, and in Parkinson’s disease the diagnosis rests mainly on the clinical picture. Blood tests and, where needed, the cerebrospinal fluid help to rule out other causes.

What do we review before treatment of a neurodegenerative disease at ANOVA IRM?

Before any treatment decision we review your neurological findings, your MRI images and reports, your current medication and how your disease has developed. We also check whether you are fit for the brief sedation needed for the fat collection.

• Standard: an MRI of the abdominal wall to exclude a hernia before the liposuction, no more than four weeks old.
• Optional: CT guidance for the application into the cerebrospinal fluid.
• Optional: further MRI scans of the brain and spinal cord, with or without contrast, where your situation calls for them.

Your own doctors at home can carry out these examinations; please send us the results. They can also be done in-house. If you would like existing findings assessed independently, we offer a second opinion. The full diagnostic pathway is described on our diagnostics page.

Dr. mult. Stehling and ANOVA IRM have been treating people with neurological and neurodegenerative diseases since 2016; 188 people so far (as of October 2026).

ANOVA IRM has manufactured MSEC in its own facility in Offenbach since 2018. Imaging is led by radiologists in the same building, and CT guidance can be used for the application into the cerebrospinal fluid. Why an autologous tissue preparation used only for our own patients requires no marketing authorisation is explained on our regulatory status page. Standard care comes first: the treatment by your neurologist remains the basis, and MSEC is offered in addition to it.

Initial evaluation can begin remotely, by phone or video, without travel to Germany. Treatment itself requires visits to Offenbach am Main, which you can reach in less than 20 minutes from Frankfurt Airport. You receive an individual written cost estimate before any treatment decision.

Request a Consultation →

In this section you will find everything about treatment for neurodegenerative diseases at ANOVA IRM: who is eligible, the process step by step and the cost.

1. 01
   Remote assessment

   Review of your neurological findings, medication and images by email, phone or video; two weeks to a few months, depending on available appointments.

2. 02
   Preliminary screening

   Blood test and existing findings in your home country, to avoid an unnecessary journey.

3. 03
   First visit — bloodwork and tissue collection

   Two days in Offenbach: consultation, consent and blood tests on day 1, then — if the results are in order — the mini-liposuction under brief sedation on day 2.

4. 04
   Production and quality control

   About four weeks; yields 10 doses.

5. 05
   Storage

   MSEC is stored at −80 °C for up to two years.

6. 06
   Application schedule

   Set individually: one dose every 4–6 weeks, or two doses every 3 months, into the cerebrospinal fluid.

Stem cell-based therapies may be considered for patients diagnosed with neurodegenerative conditions such as ALS, Parkinson’s disease, or multiple sclerosis, particularly in earlier stages of disease progression.

Suitability depends on multiple factors, including overall health, disease stage, and functional status. Not all patients are eligible, and a detailed medical evaluation is required to determine whether treatment may be appropriate.

Learn more about the diagnostic work-up →

Considering Stem Cell Therapy for a Neurodegenerative Disease?

Neurodegenerative diseases are complex, and treatment decisions require careful evaluation of both the condition and the individual patient.

At ANOVA IRM, consultations are often recommended to review medical history, diagnostic imaging, and disease progression to determine whether stem cell-based therapy may be appropriate and what approach may be most suitable.

Consultations can be conducted remotely, with on-site evaluation available where needed.

Request a consultation →

What are the contraindications for the treatment of neurodegenerative diseases?

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)

Specific to neurodegenerative diseases:

• Unable to breathe unaided, or requiring a ventilator
• Difficulty breathing in the supine position
• Dysphagia (severe difficulty swallowing)
• Psychiatric disorder that would prevent informed consent or cooperation

Treatment at ANOVA IRM is structured around standardized clinical processes for how stem cell-based therapies are sourced, processed, and applied. The method of application and timing may vary depending on the condition and patient.

Key elements of this approach include:

• Autologous stem cell sourcing: Therapies use material derived from the patient’s own body, so no foreign cells or tissue are introduced.
• Focus on therapies derived from mesenchymal stem cells (MSCs): Selected because of research interest in their possible role in immune modulation and neuroprotective signalling, particularly in conditions involving inflammation and neuronal damage.
• Use of the MSC secretome (MSEC): Treatment focuses on signalling molecules released by stem cells. This approach is investigated for its potential to act on signalling pathways involved in neurodegeneration rather than relying solely on direct cell replacement.
• Controlled processing and quality standards: All stem cell products are prepared, tested, and handled under defined protocols for quality, consistency, and traceability.
• Diagnostics-led treatment planning: Treatment is guided by the specific condition, disease stage, and diagnostic findings.
• Regulated medical framework: All treatments are performed under established German regulatory standards with clinical oversight.
• Structured treatment protocols: Depending on the condition, therapy may involve repeated applications over time as part of a broader treatment plan.

Learn more about the stem cell therapies used at ANOVA IRM →

What screening is needed before you travel for treatment of a neurodegenerative disease?

Before you travel, a preliminary screening in your home country helps you avoid an unnecessary journey. It is usually a blood test for medical or infectious-disease factors that would prevent treatment, together with your recent MRI images and your neurologist’s letters.

What happens at your first visit to Offenbach for a neurodegenerative disease?

The first visit takes two consecutive days in Offenbach and is outpatient. On day one, your doctor explains the treatment, obtains your consent and takes blood; an MRI can be added. On day two, a small amount of abdominal fat is collected by mini-liposuction under brief sedation, and the first MSEC dose follows about four to six weeks later.

How is your MSEC produced and quality-controlled?

Mesenchymal stromal cells are isolated from the fat tissue and expanded in our own facility, under official authorisation and officially inspected good professional practice (GFP, gute fachliche Praxis; similar to Good Tissue Practice, GTP, in the US, but more than GTP). The cells produce your MSEC preparation — the signalling molecules they release, not the living cells. Each batch is tested with methods validated according to the European Pharmacopoeia (Ph. Eur.) and GMP and released under a documented procedure. Production and quality control take about four weeks and yield 10 doses, stored at −80 °C for up to two years.

How is MSEC applied in neurodegenerative diseases?

Neurodegenerative diseases are chronic, usually progress over time and currently have no cure. We therefore recommend a longer-term treatment using all 10 doses produced rather than a single application; see the timeline above.

The schedule is set individually for each patient, for example:

• At the start: two doses into the cerebrospinal fluid.
• If you live close by: a single dose every 4 to 6 weeks.
• If you live further away: a double dose every 3 months, about five visits over 15 months for the 10 doses produced.
• Standard route: intrathecal, by lumbar puncture into the cerebrospinal fluid. This is intended to bring the secretome closer to the spinal cord and brain than an infusion into the bloodstream, which would have to cross the blood–brain barrier.
• Individual alternative: intravenous, if you specifically wish it or if systemic treatment is medically necessary.

Intrathecal applications are standard procedures when performed by experienced physicians; where the anatomy requires it, ANOVA IRM uses CT guidance from the radiology in the same building. The benefit-risk assessment of intrathecal administration is set out on a separate page.

MSEC treatment costs approximately €20,000–€36,000, depending on the number of doses (three to ten), and requires a two-day visit for tissue collection, followed by further visits. It is billed according to the German Medical Fee Schedule (GOÄ). The base package of the mini-liposuction and the first three MSEC doses costs approximately €20,000. Each further dose costs approximately €2,250 to €2,350, depending on the application route. Because we recommend using all 10 doses over a longer period, most treatment plans end up at the upper end of this range. Further examinations and your sedation preferences also affect the total, and you receive an individual written estimate before any decision. Our blog post on treatment cost explains the main cost factors. Travel and accommodation are not included. Treatment is generally self-funded; you can still ask your insurer about possible reimbursement. All prices are subject to change.

A double liposuction can be recommended: it yields 20 doses from one collection, which can be used over the shelf life of two years. The cost is correspondingly higher and is shown in your estimate.

Why does the cost of treatment for neurodegenerative diseases vary with the application route?

All treatments at ANOVA IRM are billed according to the German Medical Fee Schedule (Gebührenordnung für Ärzte, GOÄ); within it, the cost varies mainly with the route of application and the number of doses. For neurodegenerative diseases we mainly administer MSEC intrathecally, because the cerebrospinal fluid is a small, closed compartment in direct contact with the spinal cord and brain. Your written cost estimate shows the exact amount.

Request a Consultation →

To understand how stem cell therapy is applied, it is important to look at the underlying biological processes involved in neurodegeneration.

These conditions are characterized by the progressive loss of nerve cells (neurons) within the brain and nervous system. As these cells become damaged or die, the body gradually loses its ability to control movement, coordination, and other neurological functions.

While each condition develops differently, most share common mechanisms, including:

• progressive loss of neurons
• disruption of communication between the brain and body
• damage to structures that support nerve signalling, such as the myelin sheath
• inflammatory or immune-related activity that contributes to further damage

Because these processes continue over time, symptoms typically worsen as more of the nervous system is affected. This progressive nature is what makes neurodegenerative diseases particularly difficult to treat.

What causes neurodegenerative diseases, and what are the risk factors?

The causes differ between the diseases and are not fully understood. Common features are misfolded proteins, disturbed energy metabolism of the cells, inflammation in the nervous system and the death of nerve cells.^[2] Known risk factors are:

• Older age, the strongest risk factor for ALS and Parkinson’s disease^[3],[4]
• Genes, for example a family history or certain mutations in ALS and Parkinson’s disease
• Environmental factors, such as pesticides in Parkinson’s disease or smoking and vitamin D deficiency in MS
• For stroke: high blood pressure, air pollution, smoking, high blood sugar and high LDL cholesterol^[6]

What drives the progression of neurodegenerative diseases?

Once nerve cells start to die, the damage spreads: inflammatory support cells of the brain release messengers that can harm further nerve cells, and in MS immune cells repeatedly attack the myelin.^[2] In this way, inflammation and the loss of nerve cells reinforce each other. Our programme is aimed at this inflammation and the environment of the remaining nerve cells, not at the original cause.

The standard of care depends on the disease and is led by neurologists:

• ALS: riluzole, which can modestly prolong survival^[7]; edaravone in some countries outside the EU^[8]; and tofersen, approved in the EU since 2024, for people with a SOD1 mutation^[9],[10]
• Parkinson’s disease: levodopa, dopamine agonists and MAO-B inhibitors; in advanced stages deep brain stimulation^[11]
• MS: disease-modifying therapies such as interferons, glatiramer acetate or ocrelizumab, and cortisone for relapses^[12]
• After a stroke: medication to prevent a further stroke and rehabilitation
• For all: physiotherapy, occupational and speech therapy

These treatments can slow the course, ease symptoms and support quality of life. They often do not restore lost neurological function. The standard of care for each disease is described on our pages on ALS, Parkinson’s disease and multiple sclerosis.

How are neurodegenerative diseases diagnosed, and what do we not do ourselves?

The diagnosis of a neurodegenerative disease is made by neurologists, not by us. The work-up includes the neurological examination, MRI, nerve conduction tests, examination of the cerebrospinal fluid and blood tests, depending on the disease. MRI with or without contrast and CT guidance for an application into the cerebrospinal fluid are carried out at the Institut für Bildgebende Diagnostik in the same building, which also belongs to Dr. Stehling. We do not perform lumbar puncture for diagnosis or the neurological diagnosis itself.

Because neurodegenerative diseases involve multiple overlapping processes affecting neuronal survival and communication, treatment approaches must go beyond addressing a single symptom or pathway.

The MSC secretome (MSEC), derived from mesenchymal stem cells (MSCs), is of particular research interest due to its association with neuroprotective and immunomodulatory processes. In external laboratory research, these observations are attributed largely to what is known as the paracrine activity of stem cells, in which signalling molecules are described as influencing the surrounding cellular environment.^[16]

This is thought to occur through the release of signalling molecules, often referred to as the mesenchymal stem cell secretome. These include cytokines, growth factors, and extracellular vesicles, which are being studied in external laboratory studies and small external phase 1/2 studies for their role in immune regulation, neuronal function, and the surrounding cellular environment.^[15]

Rather than replacing lost neurons directly, stem cell-based therapies are being investigated for their potential to act on the existing nervous system by influencing the cellular environment and underlying disease processes.

Explore the research on stem cells and neurodegenerative diseases →

Mesenchymal stromal cell secretome — what the terms mean

Mesenchymal stem cells and mesenchymal stromal cells are two names for the same cells, abbreviated MSC. The International Society for Cell & Gene Therapy recommends “mesenchymal stromal cells” for the cells grown in the laboratory, and “stem cells” only where stem cell properties have been demonstrated.^[13],[14] The mesenchymal stromal cell secretome is therefore the same as the mesenchymal stem cell secretome, or MSC secretome: the mixture of growth factors, cytokines, microRNAs and extracellular vesicles such as exosomes that these cells release.^[15]

MSC secretome (MSEC)

ANOVA IRM has not yet tested MSEC in a clinical study. External laboratory and animal studies suggest that factors of the mesenchymal stromal cell secretome may protect nerve cells, dampen inflammatory support cells of the brain and support the cells that form myelin.^[16],[15] These studies used laboratory preparations, not MSEC; they provide background for the rationale, not direct evidence for MSEC.

What is the efficacy hypothesis behind MSEC in neurodegenerative diseases?

In neurodegenerative diseases, inflammation in the nervous system and the loss of nerve cells reinforce each other. The hypothesis is that the soluble factors of the MSC secretome, given into the cerebrospinal fluid, influence this environment: immune activity, inflammatory signalling and the survival of the remaining nerve cells. Two limitations belong with it: the causes of most neurodegenerative diseases remain largely unknown, and anti-inflammatory approaches have so far shown only moderate effects. Our aim is to slow progression, not to cure the disease.

Mesenchymal stem cells in clinical studies of neurodegenerative diseases

In small external phase 1/2 and 2a studies in ALS, mesenchymal stem cells induced in culture to secrete neurotrophic factors (MSC-NTF) were well tolerated, and disease progression appeared slower in some patients.^[17] In an external meta-analysis of mostly small, uncontrolled phase 1/2 studies in MS, about 40 per cent of patients improved after mesenchymal stem cells, about a third remained stable and about 18 per cent worsened.^[18] Without control groups, such figures do not show an effect.

In the external phase 3 study of these MSC-NTF cells in ALS, a benefit over placebo could not yet be demonstrated in the whole study population.^[19] In a meta-analysis of 11 small randomised external studies (691 patients in total) of haematopoietic and mesenchymal stem cells in MS, a benefit over the control treatment could not yet be demonstrated either.^[20] These studies used living cells, not MSEC.

Talk to us about current changes or additions to the programme. For a number of conditions ANOVA IRM also offers infusion therapies alongside the components described above.

Request a Consultation →

We have no evaluated dataset of our own for neurodegenerative diseases yet. What we can say about MSEC therefore rests on the published literature and on the rationale described above. Individual accounts from patients are collected on our testimonials page; they are personal reports, not outcome data.

What the published evidence on neurodegenerative diseases does not yet tell us

• Most clinical studies of mesenchymal stem cells in neurodegenerative diseases are small and early.
• Repair of damaged nerve tissue is what research in this field hopes for; it is not something we can promise today.
• In Germany and the EU, no stem cell-based treatment is approved for ALS, Parkinson’s disease or multiple sclerosis.

MSEC is an autologous tissue preparation, which ANOVA IRM manufactures under a procurement authorisation (Section 20b AMG) and a manufacturing authorisation under Section 20c AMG, issued and regularly inspected by the Hessian State Office for Health and Care (HLfGP). The individual treatment attempt (individueller Heilversuch) concerns the administration only and follows full disclosure and informed consent. Because the product is used only for ANOVA IRM’s own patients, no authorisation under Section 4b, no marketing authorisation under Section 21 and no approval under Section 21a AMG is required. The full derivation is on our regulatory status page.

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

• Who are we?
• Is ANOVA legal?
• Is stem cell therapy safe?
• What is MSC secretome (MSEC)?
• What is BMC (Bone Marrow Concentrate)?
• What are stem cells?
• What should I ask when looking for a stem cell treatment?
• Which conditions do we treat?
• Benefit-risk assessment of intrathecal administration
• Does the secretome pass the blood–brain barrier?
• HAL robotic exoskeleton training
• Science: stem cells and neurodegenerative diseases

Request a Consultation →

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, condition-specific diagnostics — including MRI with contrast and CT guidance for intrathecal applications — can be performed in-house rather than referred elsewhere. See diagnostics at ANOVA IRM.

Specific literature is maintained on the pages for ALS, Parkinson’s disease, multiple sclerosis and stroke, and general literature on the MSC secretome page.

Neurological and neurodegenerative diseases — frequency and mechanisms

• [1] GBD 2021 Nervous System Disorders Collaborators. Global, regional, and national burden of disorders affecting the nervous system, 1990–2021: a systematic analysis for the Global Burden of Disease Study 2021. Lancet Neurol. 2024;23(4):344–381. doi:10.1016/S1474-4422(24)00038-3. PMID: 38493795.
• [2] Wilson DM 3rd, Cookson MR, Van Den Bosch L, et al. Hallmarks of neurodegenerative diseases. Cell. 2023;186(4):693–714. doi:10.1016/j.cell.2022.12.032. PMID: 36803602.
• [3] van Es MA, Hardiman O, Chio A, et al. Amyotrophic lateral sclerosis. Lancet. 2017;390(10107):2084–2098. doi:10.1016/S0140-6736(17)31287-4. PMID: 28552366.
• [4] Bloem BR, Okun MS, Klein C. Parkinson’s disease. Lancet. 2021;397(10291):2284–2303. doi:10.1016/S0140-6736(21)00218-X. PMID: 33848468.
• [5] Walton C, King R, Rechtman L, et al. Rising prevalence of multiple sclerosis worldwide: insights from the Atlas of MS, third edition. Mult Scler. 2020;26(14):1816–1821. doi:10.1177/1352458520970841. PMID: 33174475.
• [6] GBD 2021 Stroke Risk Factor Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990–2021: a systematic analysis for the Global Burden of Disease Study 2021. Lancet Neurol. 2024;23(10):973–1003. doi:10.1016/S1474-4422(24)00369-7. PMID: 39304265.

Standard of care

• [7] Miller RG, Mitchell JD, Moore DH. Riluzole for amyotrophic lateral sclerosis (ALS)/motor neuron disease (MND). Cochrane Database Syst Rev. 2012;(3):CD001447. doi:10.1002/14651858.CD001447.pub3. PMID: 22419278.
• [8] Writing Group; Edaravone (MCI-186) ALS 19 Study Group. Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2017;16(7):505–512. doi:10.1016/S1474-4422(17)30115-1. PMID: 28522181.
• [9] Miller TM, Cudkowicz ME, Genge A, et al. Trial of antisense oligonucleotide tofersen for SOD1 ALS. N Engl J Med. 2022;387(12):1099–1110. doi:10.1056/NEJMoa2204705. PMID: 36129998.
• [10] European Medicines Agency. Qalsody (tofersen): EPAR — medicine overview; authorised in the EU in 2024 for adults with ALS and a SOD1 mutation. https://www.ema.europa.eu/en/medicines/human/EPAR/qalsody (accessed 9 October 2026).
• [11] Armstrong MJ, Okun MS. Diagnosis and treatment of Parkinson disease: a review. JAMA. 2020;323(6):548–560. doi:10.1001/jama.2019.22360. PMID: 32044947.
• [12] McGinley MP, Goldschmidt CH, Rae-Grant AD. Diagnosis and treatment of multiple sclerosis: a review. JAMA. 2021;325(8):765–779. doi:10.1001/jama.2020.26858. PMID: 33620411.

Mesenchymal stromal cells and their secretome — terms and mechanisms

• [13] Dominici M, Le Blanc K, Mueller I, et al. Minimal criteria for defining multipotent mesenchymal stromal cells. The International Society for Cellular Therapy position statement. Cytotherapy. 2006;8(4):315–317. doi:10.1080/14653240600855905. PMID: 16923606.
• [14] Viswanathan S, Shi Y, Galipeau J, et al. Mesenchymal stem versus stromal cells: International Society for Cell & Gene Therapy (ISCT®) Mesenchymal Stromal Cell committee position statement on nomenclature. Cytotherapy. 2019;21(10):1019–1024. doi:10.1016/j.jcyt.2019.08.002. PMID: 31526643.
• [15] Vizoso FJ, Eiro N, Cid S, et al. Mesenchymal stem cell secretome: toward cell-free therapeutic strategies in regenerative medicine. Int J Mol Sci. 2017;18(9):1852. doi:10.3390/ijms18091852. PMID: 28841158.
• [16] Staff NP, Jones DT, Singer W. Mesenchymal stromal cell therapies for neurodegenerative diseases. Mayo Clin Proc. 2019;94(5):892–905. doi:10.1016/j.mayocp.2019.01.001. PMID: 31054608.

Mesenchymal stem cells in neurodegenerative diseases — clinical studies (other products than MSEC)

• [17] Petrou P, Gothelf Y, Argov Z, et al. Safety and clinical effects of mesenchymal stem cells secreting neurotrophic factor transplantation in patients with amyotrophic lateral sclerosis: results of phase 1/2 and 2a clinical trials. JAMA Neurol. 2016;73(3):337–344. doi:10.1001/jamaneurol.2015.4321. PMID: 26751635.
• [18] Islam MA, Alam SS, Kundu S, et al. Mesenchymal stem cell therapy in multiple sclerosis: a systematic review and meta-analysis. J Clin Med. 2023;12(19):6311. doi:10.3390/jcm12196311. PMID: 37834955.
• [19] Cudkowicz ME, Lindborg SR, Goyal NA, et al. A randomized placebo-controlled phase 3 study of mesenchymal stem cells induced to secrete high levels of neurotrophic factors in amyotrophic lateral sclerosis. Muscle Nerve. 2022;65(3):291–302. doi:10.1002/mus.27472. PMID: 34890069 (industry-sponsored).
• [20] Maji S, Mishra A, Srinivasan A, Maiti R. Efficacy and safety of hematopoietic and mesenchymal stem cells in multiple sclerosis: a meta-analysis. Neurol Res. 2026;48(1):96–106. doi:10.1080/01616412.2025.2521712. PMID: 40566801.

Approval status

• [21] Nam JY, Chun S, Lee TY, et al. Long-term survival benefits of intrathecal autologous bone marrow-derived mesenchymal stem cells (Neuronata-R®: lenzumestrocel) treatment in ALS: propensity-score-matched control, surveillance study. Front Aging Neurosci. 2023;15:1148444. doi:10.3389/fnagi.2023.1148444. PMID: 37122380 (manufacturer-affiliated; conditional approval by the Korean MFDS in 2013).
• [22] Sumitomo Pharma Co., Ltd. Press release: conditional and time-limited approval in Japan of AMCHEPRY (raguneprocel), allogeneic iPS cell-derived dopaminergic progenitor cells, for Parkinson’s disease. 6 March 2026. https://www.sumitomo-pharma.com/news/20260306.html (accessed 28 September 2026).