The ANOVA SCI Stem Cell Secretome
Treatment Programme Germany

The spinal cord connects the brain with the peripheral nerves; damage to it can disrupt movement, sensation and the control of bladder, bowel and blood pressure. Surgery, medication, physiotherapy and neuro-rehabilitation remain the basis of treatment. ANOVA IRM manufactures MSEC in its own facility in Offenbach, under official authorisation and officially inspected good professional practice (GFP). GFP is the German counterpart of Good Tissue Practice (GTP) in the US. A registration with the US FDA is, on its own, no official confirmation that the rules are met. In Germany, by contrast, GFP is a condition of the official authorisation and is regularly inspected by the authorities. MSEC is cell-free: it contains the signalling molecules released by the patient's own mesenchymal stromal cells, not the cells themselves. Since 2019, patients can combine it with training in the HAL robotic exoskeleton, provided by Cyberdyne Care Robotics in Bochum, Germany.

A spinal cord injury (SCI), also called spinal cord trauma, damages the nerve pathways that carry signals between the brain and the body. Depending on the level of the injury, it leads to paralysis of the legs (paraplegia) or of the arms and legs (tetraplegia), together with loss of sensation and of bladder, bowel and sexual function. Most injuries are traumatic — road traffic accidents, falls, sports injuries or violence — and around 60% affect the neck (cervical spine).

Clinicians describe an injury as complete or incomplete using the ASIA Impairment Scale (AIS A to E) and distinguish an acute, a subacute and a chronic phase. Diagnosis rests on a standardised neurological examination and on MRI or CT of the spine. To date no cure is known for spinal cord injury.

Common consequences include weakness or paralysis below the injury, loss of sensation, muscle stiffness and spasms (spasticity), nerve pain, bladder and bowel problems and, in higher injuries, breathing difficulties.

More details can be found below in our scientific section on spinal cord injury.

ANOVA offers autologous MSC secretome (MSEC) therapy for spinal cord injury, given intrathecally into the cerebrospinal fluid. The programme can be combined with HAL robotic exoskeleton training at Cyberdyne Care Robotics in Bochum; MSEC can also be given on its own or in another combination. Bone marrow concentrate (BMC) is not part of the SCI programme.

Stem cells are thought to act mainly through soluble factors, together called the secretome, which includes exosomes and many other factors. After a spinal cord injury, the initial trauma is followed by inflammation, swelling and scarring around the injured segment. MSEC is intended to influence this environment; if combined with it, HAL training is intended to make active use of the remaining nerve pathways. Whether the combination works better than either part alone has not been tested in a controlled trial; the evidence is set out in the clinical and scientific section below.

The signalling molecules released by the patient's own mesenchymal stromal cells, given intrathecally into the cerebrospinal fluid around the injured spinal cord. External laboratory and animal studies suggest they may dampen inflammation, influence glial scarring and support the growth of blood vessels and nerve fibres. Small external phase 1 and phase 2 studies with MSC products in SCI mainly examined safety and gave mixed results; MSEC itself has not been tested in a clinical trial in SCI.

A robotic exoskeleton for the legs that reads the weak bioelectrical signals still reaching the skin and moves the joints accordingly; the movement is fed back to the brain as sensory information. Training takes place at Cyberdyne Care Robotics in Bochum, five days a week over 12 weeks. In small external studies in chronic SCI, walking without the exoskeleton improved after about three months of training; there was no control group.^{[19],[20],[21]} HAL is a CE-marked medical device.^[18] It is an optional component: ANOVA IRM's MSEC treatment does not depend on it.

Which tests are used to diagnose spinal cord injury?

Spinal cord injury is diagnosed with a standardised neurological examination according to the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI), which determine the neurological level and the AIS grade. CT shows injuries to the bones of the spine. MRI of the spine, with contrast where needed, shows the spinal cord itself — bleeding, swelling, compression and, later, scarring or fluid-filled cavities. Walking function is measured with tests such as the 10-metre walk test, the 6-minute walk test and the WISCI II scale.

What do we review before SCI treatment at ANOVA IRM?

Before any treatment decision we review your neurological findings and AIS grade, your spinal MRI reports, your rehabilitation so far and your breathing function. We also assess whether you are fit for the brief sedation required for tissue collection. If you choose HAL training, Cyberdyne Care Robotics in Bochum assesses whether it is suitable for you.

• Standard: an MRI of the abdominal wall to exclude a hernia is required before the liposuction, taken no more than four weeks beforehand. It can be done at home or at ANOVA IRM.
• Optional: CT guidance for the intrathecal application at ANOVA IRM, used while the dose is given — for example after spinal surgery with implants.
• Optional: further MRI scans of the spine, with or without contrast, where your situation calls for them — for example to show the current state of the injured segment.

Imaging can be carried out in-house; all examinations can also be done by your own doctors. The full diagnostic pathway is described on our diagnostics page.

ANOVA IRM has held the German authorisations for manufacturing MSEC since 2018, and the facility is inspected by the authorities. Since 2019 we have worked with Cyberdyne Care Robotics, which provides HAL training in Bochum for patients who choose to combine it with MSEC. Why a preparation from your own cells, used only for our own patients, needs no marketing authorisation is explained on our regulatory status page.

Your case is first reviewed remotely, by phone or video, before you travel to Germany. Treatment itself takes place in person: in Offenbach am Main, less than 20 minutes from Frankfurt Airport, and, if you add HAL training, in Bochum. You receive an individual written cost estimate before any treatment decision.

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MSEC treatment for spinal cord injury at ANOVA IRM costs approximately €20,000–€36,000; HAL training, if chosen, is billed separately by Cyberdyne Care Robotics. It requires a two-day outpatient visit to Offenbach, Germany, for tissue collection, followed by further visits for the applications according to your individual treatment plan. It is available to people with spinal cord injury after individual medical review.

1. 01
   Initial evaluation

   Remote, by phone or video — typically 2 weeks to a few months

2. 02
   Preliminary screening

   In your home country, to avoid an unnecessary journey

3. 03
   First visit — bloodwork and tissue collection

   Two-day outpatient visit to Offenbach: bloodwork on day 1, then — if the results are in order — mini-liposuction under brief sedation on day 2

4. 04
   Production and quality control

   Approximately 4 weeks; yields 10 doses per production cycle

5. 05
   Storage

   Up to 2 years, allowing an individual schedule — with or without HAL training

6. 06
   Application schedule

   Set individually; with HAL training: five visits during the 12 weeks, two intrathecal doses each, about every 2 to 2½ weeks

We consider people with a spinal cord injury at cervical, thoracic or lumbar level, in particular incomplete or partial injuries, including traumatic injuries, spinal cord compression and swelling of the spinal cord after surgery. Complete injuries are considered only in selected cases. For chronic injuries, we discuss realistic goals with you beforehand. You need to be well enough for the brief sedation required for tissue collection and able to breathe independently and comfortably while lying down. If you choose HAL training, Cyberdyne Care Robotics assesses separately whether it is suitable. Every treatment recommendation follows a full clinical evaluation, and applying for an evaluation does not mean that treatment will be offered.

What are the contraindications for SCI treatment?

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 spinal cord injury:

• Unable to breathe unaided, or requiring a ventilator
• Difficulty breathing in the supine position

What screening is needed before you travel for SCI treatment?

Before you travel, a preliminary screening in your home country — usually a blood test for HIV, hepatitis, syphilis and other active infections — helps you avoid an unnecessary journey. It also looks for medical factors that would already rule out treatment.

What happens at your first SCI visit to Offenbach, Germany?

The first treatment visit takes two days in Offenbach, on an outpatient basis. On day 1 you have your bloodwork and complete the paperwork at ANOVA IRM; the tests are repeated here as German medical rules require. If the results are in order, a small amount of abdominal fat tissue is collected on day 2 by mini-liposuction under brief sedation. From this point to the first secretome application is about four weeks, and you can return home in between.

How is your MSEC for SCI produced and quality-controlled?

Mesenchymal stromal cells are isolated from the collected tissue and expanded under controlled conditions in our own facility in Offenbach, under official authorisation and officially inspected good professional practice (GFP). These cells are then used to produce your MSEC preparation — the signalling molecules they release, not the living cells. Production and quality control take approximately four weeks and yield 10 doses per production cycle. Each patient batch is tested with methods validated according to the European Pharmacopoeia (Ph. Eur.) and GMP, and released under a documented procedure; the released secretome is stored at −80 °C and keeps for up to two years.

How often is MSEC applied in SCI?

Because spinal cord injury is a lasting condition, we recommend a longer-term treatment using all 10 doses produced rather than a single application; see the timeline above. If you combine MSEC with HAL training, the 10 doses are given during the 12 weeks of training, so that both parts run in parallel. Other schedules are possible, for example MSEC without HAL.

The schedule is set individually for each patient, for example with HAL training:

• HAL training (optional): 12 weeks at Cyberdyne Care Robotics in Bochum, five days a week; you stay in private accommodation near the centre, with nursing support available if needed.
• MSEC with HAL: five outpatient visits to Offenbach during the training, about every 2 to 2½ weeks, with two intrathecal doses per visit.
• Standard route for SCI: intrathecal, by lumbar puncture into the cerebrospinal fluid. This is intended to bring the secretome directly to the injured spinal cord. An infusion into the bloodstream would have to cross the blood–brain barrier and the corresponding barrier of the spinal cord.
• Individual alternative: intravenous, if you specifically wish it or if systemic treatment is medically necessary.

Each application visit takes about three hours: the secretome is thawed after you arrive, the injection is given in a monitored procedure room, and you are observed for about an hour before discharge. Intrathecal applications are standard procedures when performed by experienced physicians; where the anatomy requires it, ANOVA IRM uses CT guidance from its in-house radiology. The benefit-risk assessment of intrathecal administration is set out on a separate page.

MSEC treatment for spinal cord injury costs approximately €20,000 to €36,000 and is billed according to the German Medical Fee Schedule (GOÄ). The base package — the mini-liposuction and the first three MSEC doses — costs approximately €20,000; each further dose is charged separately at approximately €2,250 to €2,350 depending on the application route. Because we recommend using all 10 doses for a lasting condition such as spinal cord injury, most treatment plans end up at the upper end of this range. If you add HAL training, it is provided and billed separately by Cyberdyne Care Robotics in Bochum: about €500 per session, or approximately €10,000 to €30,000 depending on the training stage. You receive an individual written estimate before any treatment decision. Our blog post on treatment cost explains what drives the cost of stem cell treatment in general. Travel and accommodation are separate. All prices are subject to change.

Because spinal cord injury is a lasting condition, a double liposuction can be recommended: it yields 20 doses, which can be used over the current shelf life of two years from a single collection. The cost is correspondingly higher and is shown in your individual estimate.

Why does the cost of SCI treatment 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. For spinal cord injury we mainly administer MSEC intrathecally, because in our assessment it is most likely to act there: the cerebrospinal fluid is in direct contact with the injured spinal cord. We use intravenous administration only if you specifically wish it or if systemic treatment is medically necessary. The exact cost of your treatment plan is set out in your individual written cost estimate.

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Damage to the spinal cord occurs in two phases. The primary injury is the mechanical damage at the moment of trauma. It is followed by a secondary injury cascade — reduced blood flow (ischaemia), inflammation, swelling and programmed cell death — that can extend the damage over the following days and weeks.^[1] This is why early treatment aims to relieve pressure on the spinal cord and to keep it supplied with blood.^[5],[6],[7]

Injuries are classified with the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) and the ASIA Impairment Scale. AIS A means a complete injury with no sensory or motor function in the lowest sacral segments. AIS B to D describe incomplete injuries with increasing preserved function, and AIS E means normal function in a person who previously had deficits.^[4] Depending on the level, the result is tetraplegia (cervical injuries) or paraplegia (thoracic, lumbar or sacral injuries).

For many years, the neurological status shortly after injury was taken to predict recovery reliably, with little further improvement expected in the chronic phase. More recent research has questioned how fixed these limits are, and has shown changes in the brain itself after SCI, not only at the injured segment.^[22] This is an evolving field, not a settled consensus. It is part of the rationale for combining a biological approach (MSEC) with active training (HAL).

What causes spinal cord injury, and what are the risk factors?

Most spinal cord injuries are caused by trauma. What causes the injury and what drives the damage afterwards are two different questions; the next section deals with the course after the injury.^[1]

• Road traffic accidents: in North America about 38% of injuries.^[1]
• Falls: about 31%, increasingly in older people.^[1]
• Sports and recreational injuries: about 10–17%; violence is a further cause.^[1],[3]
• Sex and age: about 80% of those affected are male; injuries peak between the ages of 15 and 29, with a second, growing peak over 50.^[1]
• Non-traumatic causes: the spinal cord can also be damaged by tumours, degenerative narrowing of the spinal canal, infections or reduced blood flow.

What drives the course after a spinal cord injury?

The injury itself is the cause; the drivers of the damage that follows are a separate question. Inflammatory cells enter the injured cord and release mediators that can harm nerve cells but may also support clearance and repair.^[9] Over weeks, a glial scar forms around the lesion; it limits the damage but also blocks nerve fibres from growing across it.^[10] Loss of myelin and nerve cells, and later changes in the brain, add to the loss of function.^[1],[22]

This is where our programme aims — at the tissue environment and the use of the remaining pathways, not at the original cause, and not at a cure.

Acute spinal cord injury is treated in specialised centres. The AO Spine guideline, updated in 2024, recommends offering early surgical decompression within 24 hours of injury, regardless of the level of the injury.^[6] A 24-hour infusion of high-dose methylprednisolone within eight hours of injury is suggested as a treatment option, but not when started later.^[5] Mean arterial blood pressure is kept at at least 75–80 mmHg, and not higher than 90–95 mmHg, for three to seven days.^[7]

The drug riluzole did not meet its primary endpoint in an external randomised phase 2/3 trial in acute SCI; the trial was stopped early and was underpowered.^[8] Rehabilitation — physiotherapy, occupational therapy, respiratory care, bladder and bowel management, and treatment of spasticity and nerve pain — continues for life.^[1],[3] The ANOVA programme is offered alongside this care, not in place of it.

How is spinal cord injury diagnosed, and what do we not do ourselves?

The diagnosis and classification of spinal cord injury are made by specialists in spinal cord injury centres, not by us. The work-up includes the ISNCSCI examination with AIS grade, CT and MRI of the spine, and, where needed, neurophysiological tests and urodynamic examination of the bladder.^[1],[4]

What we do ourselves is imaging: MRI with or without contrast, and CT guidance for an intrathecal application. This is carried out at the Prof. Dr. Stehling Institut für Bildgebende Diagnostik GmbH in the same building, which also belongs to Dr. Stehling. We do not perform the neurological classification, neurophysiological tests or bladder examinations; please bring these findings from your treating centre.

MSC secretome (MSEC)

Early concepts assumed that mesenchymal stem cells replace lost nerve cells; later research did not support this. In external laboratory and animal studies, mesenchymal cells and their secretome have been reported to influence inflammation, the structure of the glial scar, the growth of nerve fibres and the formation of new blood vessels.^[10],[11] In an external animal study in rats, grafted mesenchymal stem cells improved recovery through the release of growth factors and the support of new blood vessels.^[11]

External systematic reviews of clinical studies with MSC products in SCI — mostly small and uncontrolled — describe an acceptable short-term safety profile and improvements in AIS grade or sensory scores in some patients.^[12],[15] A meta-analysis of the controlled studies found no clear clinical benefit.^[13] Another meta-analysis of 62 trials concluded that clinical translation is still premature.^[14] In a small external randomised, placebo-controlled phase 1/2 trial in chronic incomplete SCI, intrathecal MSC injections were well tolerated but showed no significant difference from placebo.^[16] MSEC itself has not been tested in a clinical trial in SCI.

What is the efficacy hypothesis behind MSC secretome in SCI?

After a spinal cord injury, inflammation, glial scarring and a poor blood supply limit what the surviving nerve fibres can do.^[9],[10] The hypothesis is that the soluble factors of the secretome, given into the cerebrospinal fluid, influence this environment and make it more permissive for the remaining pathways.^[11]

A possible endpoint for testing this would be walking function without assistance, for example on the 10-metre walk test or the WISCI II scale, compared with HAL training alone. Two limitations belong with it: an effect of MSEC in SCI has not been shown in a controlled trial, and the combination with HAL has not been compared with HAL alone.

HAL robotic exoskeleton training

HAL detects the weak bioelectrical signals that still reach the skin of the legs, interprets the intended movement and supports it with motors at the hip and knee. The resulting movement generates sensory feedback to the brain; Cyberdyne describes this repeated loop as the basis of the training effect.^[18] HAL Lower Limb is CE-marked; according to the manufacturer, its uses include SCI at T8–L5 (AIS A–D) and at C2–T7 (AIS C–D).^[18]

In a small external pilot study, eight people with chronic SCI walked better without the exoskeleton after 90 days of training.^[19] In a second small external study with 21 patients, mobility without the exoskeleton improved after 90 days.^[20] A further external study analysed 55 patients with chronic SCI after 12 weeks of training five times a week. The time for the 10-metre walk test fell by 47%, and the 6-minute walking distance rose by 50%.^[21] Younger patients improved somewhat more, but the age difference was not statistically significant.^[21]

External studies also reported changes in the processing of sensory signals in the brain and improvements in bowel function after HAL training.^[22],[23] These studies had no control group, and they examined HAL alone, without stem cells. A randomised trial of this kind of training in chronic spinal cord injury, funded by the German Federal Joint Committee, began in 2026.^[25]

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.

We have no evaluated dataset of our own for spinal cord injury yet. What we can say about MSEC in SCI therefore rests on the published literature and on the rationale described above. Personal accounts from patients are collected in our testimonials; they are individual reports, not outcome data.

Stem cell-based therapy for spinal cord injury remains experimental, and outcomes vary from patient to patient. Goals are agreed individually and may include walking with aids, independence in daily life, spasticity, nerve pain, sensation and quality of life. Treatment cannot guarantee restored walking ability, relief of symptoms or full neurological recovery.

What is the realistic goal of SCI treatment?

The aim of rehabilitation after spinal cord injury is to make the most of the function that remains and to prevent complications. For MSEC, alone or combined with HAL, the aim is better use of remaining function, not the repair of the spinal cord. Research in this field continues, but no one can honestly promise a date for a cure.

MSEC is an autologous tissue preparation made from the patient's own cells. ANOVA IRM manufactures it 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. HAL is a CE-marked medical device operated by Cyberdyne Care Robotics.^[18] The full derivation for MSEC 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

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 Prostate Center. Because imaging is carried out in the same building, condition-specific diagnostics — including CT-guided intrathecal applications — can be performed in-house rather than referred elsewhere. See diagnostics at ANOVA IRM.

Spinal cord injury — overview, classification and epidemiology

• [1] Ahuja CS, Wilson JR, Nori S, et al. Traumatic spinal cord injury. Nat Rev Dis Primers. 2017;3:17018. doi:10.1038/nrdp.2017.18. PMID: 28447605.
• [2] GBD 2016 Traumatic Brain Injury and Spinal Cord Injury Collaborators. Global, regional, and national burden of traumatic brain injury and spinal cord injury, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019;18(1):56–87. doi:10.1016/S1474-4422(18)30415-0. PMID: 30497965.
• [3] World Health Organization. Spinal cord injury. Fact sheet, 16 April 2024. Accessed 28 September 2026. https://www.who.int/news-room/fact-sheets/detail/spinal-cord-injury
• [4] Rupp R, Biering-Sørensen F, Burns SP, et al. International Standards for Neurological Classification of Spinal Cord Injury: revised 2019. Top Spinal Cord Inj Rehabil. 2021;27(2):1–22. doi:10.46292/sci2702-1. PMID: 34108832.

Acute management and standard care

• [5] Fehlings MG, Tetreault LA, Wilson JR, et al. A clinical practice guideline for the management of acute spinal cord injury: introduction, rationale, and scope. Global Spine J. 2017;7(3 Suppl):84S–94S. doi:10.1177/2192568217703387. PMID: 29164036.
• [6] Fehlings MG, Tetreault LA, Hachem L, et al. An update of a clinical practice guideline for the management of patients with acute spinal cord injury: recommendations on the role and timing of decompressive surgery. Global Spine J. 2024;14(3 Suppl):174S–186S. doi:10.1177/21925682231181883.
• [7] Kwon BK, Tetreault LA, Martin AR, et al. A clinical practice guideline for the management of patients with acute spinal cord injury: recommendations on hemodynamic management. Global Spine J. 2024;14(3 Suppl):187S–211S. doi:10.1177/21925682231202348. PMID: 38526923.
• [8] Fehlings MG, Moghaddamjou A, Harrop JS, et al. Safety and efficacy of Riluzole in Acute Spinal Cord Injury Study (RISCIS): a multi-center, randomized, placebo-controlled, double-blinded trial. J Neurotrauma. 2023;40(17-18):1878–1888. doi:10.1089/neu.2023.0163.

Disease mechanisms

• [9] Donnelly DJ, Popovich PG. Inflammation and its role in neuroprotection, axonal regeneration and functional recovery after spinal cord injury. Exp Neurol. 2008;209(2):378–388. doi:10.1016/j.expneurol.2007.06.009. PMID: 17662717.
• [10] Bradbury EJ, Burnside ER. Moving beyond the glial scar for spinal cord repair. Nat Commun. 2019;10:3879. doi:10.1038/s41467-019-11707-7. PMID: 31462640.

MSC and cell-based therapies in spinal cord injury

• [11] Quertainmont R, Cantinieaux D, Botman O, et al. Mesenchymal stem cell graft improves recovery after spinal cord injury in adult rats through neurotrophic and pro-angiogenic actions. PLoS One. 2012;7(6):e39500. doi:10.1371/journal.pone.0039500. PMID: 22745769.
• [12] Montoto-Meijide R, Meijide-Faílde R, Díaz-Prado SM, et al. Mesenchymal stem cell therapy in traumatic spinal cord injury: a systematic review. Int J Mol Sci. 2023;24(14):11719. doi:10.3390/ijms241411719. PMID: 37511478.
• [13] Kvistad CE, Kråkenes T, Gjerde C, et al. Safety and clinical efficacy of mesenchymal stem cell treatment in traumatic spinal cord injury, multiple sclerosis and ischemic stroke — a systematic review and meta-analysis. Front Neurol. 2022;13:891514. doi:10.3389/fneur.2022.891514. PMID: 35711260.
• [14] Shang Z, Wang M, Zhang B, et al. Clinical translation of stem cell therapy for spinal cord injury still premature: results from a single-arm meta-analysis based on 62 clinical trials. BMC Med. 2022;20:284. doi:10.1186/s12916-022-02482-2. PMID: 36058903.
• [15] Troiani Z, Chipman DE, Ryan TJ, et al. Efficacy of mesenchymal and embryonic stem cell therapy for the treatment of spinal cord injury: a systematic review and meta-analysis of human studies. Global Spine J. 2025;15(8):3969–3981. doi:10.1177/21925682251345450. PMID: 40407042.
• [16] Martins Braga F, Kumru H, Benito-Penalva J, et al. Mesenchymal stromal/stem cells in chronic incomplete traumatic spinal cord injury: a phase I/II double-blind placebo-controlled multicentre trial. Biomedicines. 2026;14(4):762. doi:10.3390/biomedicines14040762. PMID: 42072303 (ClinicalTrials.gov NCT05054803).

Approval status

• [17] Nipro Corporation. Press release: application for full approval of STEMIRAC, autologous bone marrow-derived mesenchymal stem cells for spinal cord injury, in Japan (conditional and time-limited approval since December 2018). 14 November 2025. Accessed 28 September 2026. https://kyodonewsprwire.jp/release/202511139038

HAL robotic exoskeleton

• [18] Cyberdyne Care Robotics GmbH. HAL Lower Limb (HAL-ML05): medical device, CE 0197; indications and mode of operation. Accessed 28 September 2026. https://www.cyberdyne.eu/en/products/medical-device/hal-limb/
• [19] Aach M, Cruciger O, Sczesny-Kaiser M, et al. Voluntary driven exoskeleton as a new tool for rehabilitation in chronic spinal cord injury: a pilot study. Spine J. 2014;14(12):2847–2853. doi:10.1016/j.spinee.2014.03.042. PMID: 24704677.
• [20] Jansen O, Grasmuecke D, Meindl RC, et al. Hybrid Assistive Limb exoskeleton HAL in the rehabilitation of chronic spinal cord injury: proof of concept; the results in 21 patients. World Neurosurg. 2018;110:e73–e78. doi:10.1016/j.wneu.2017.10.080. PMID: 29081392.
• [21] Grasmücke D, Zieriacks A, Jansen O, et al. Against the odds: what to expect in rehabilitation of chronic spinal cord injury with a neurologically controlled Hybrid Assistive Limb exoskeleton. A subgroup analysis of 55 patients according to age and lesion level. Neurosurg Focus. 2017;42(5):E15. doi:10.3171/2017.2.FOCUS171. PMID: 28463613.
• [22] Sczesny-Kaiser M, Höffken O, Aach M, et al. HAL® exoskeleton training improves walking parameters and normalizes cortical excitability in primary somatosensory cortex in spinal cord injury patients. J Neuroeng Rehabil. 2015;12:68. doi:10.1186/s12984-015-0058-9. PMID: 26289818.
• [23] Brinkemper A, Grasmücke D, Yilmaz E, et al. Influence of locomotion therapy with the wearable cyborg HAL on bladder and bowel function in acute and chronic SCI patients. Global Spine J. 2023;13(3):668–676. doi:10.1177/21925682211003851. PMID: 33858209.

Reimbursement of HAL training in Germany

• [24] Cyberdyne Inc. Cybernics Treatment: reimbursement by the German statutory accident insurance (DGUV). Accessed 28 September 2026. https://cyberdyne.jp/english/services/CybernicsTreatment.html
• [25] Gemeinsamer Bundesausschuss (G-BA). Erprobungs-Richtlinie Neuromuskuläre Feedbacktherapie bei Querschnittlähmung (EFeQT-Studie). Beschluss vom 17. August 2023; Studienbeginn 24. August 2026. Accessed 28 September 2026. https://www.g-ba.de/studien/erprobung/efeqt-studie/

General MSC, extracellular vesicle and secretome literature is maintained on the MSC secretome page; bone marrow literature on the BMC page.