Protect axons
Under normal conditions, Schwann cells wrap around axons to form myelin sheaths and protect the axons.
SCHWANN CELL THERAPY / NERVE REGENERATION
Reconnect
Reconnect
Damaged Nerves
SCAD is advancing cell therapy using ES/iPS cell-derived Schwann cells to support the repair and regeneration of damaged nerves --- from peripheral nerve disorders to more severe neurological injuries, including spinal cord injury.
CG images are conceptual representations of the therapeutic approach.
01 / WHY SCHWANN CELLS
Schwann cells not only form myelin sheaths that protect axons, but also, after nerve injury, they transform to a repair phenotype and support nerve regeneration through multiple mechanisms.
Shift to a repair phenotype after injury
They migrate to the injury site, help to clear damaged tissues, form a scaffold for axonal growth, and contribute to the regenerative environment.
Produce multiple regenerative factors
They produce neurotrophic factors, angiogenic factors, extracellular matrix components, and other molecules that support regeneration.
02 / REPAIR MECHANISMS
Multiple mechanisms
work together to support nerve regeneration
Schwann cells produce multiple cytokines, extracellular matrix components, and other factors involved in nerve repair.
Axonal growthGrowth and neurotrophic factors such as NGF / GDNF / Osteopontin
AngiogenesisVEGF / PDGF-BB / Angiogenin and other factors
Clearance of damaged tissueCCL2 recruits macrophages that engulf and digest cellular debris through phagocytosis
Scaffold formation for axonal regenerationExtracellular matrix components such as laminins
Suppression of glial scar formationTIMP1 / TIMP2 and related factors may suppress scar formation that impedes axonal growth
RemyelinationSupport for myelin formation after axonal regeneration
NGFGDNFVEGFCCL2TIMP1/2Laminins
03 / WHY SCAD
Cells with therapeutic potential,
at the scale required for treatment
Conventional Schwann cell therapy has relied on cells harvested from patients or donor nerves, creating constraints in supply and scale. SCAD uses ES/iPS cells as the starting material for stable manufacturing of clinical-grade Schwann cells.
CONVENTIONAL LIMITATION
Patient- or donor-derived cells
- Limited number of cells available from each harvest
- Invasive nerve harvesting from the patient
- Long lead time from harvesting to transplantation
- Challenges in standardization, scale-up, and consistent quality
SCAD PLATFORM
ES/iPS cell-derived Schwann cell lines
- Stable manufacturing from pluripotent stem cells
- Scalable expansion and differentiation processes
- Cryopreserved, off-the-shelf product format
- Clinical-grade manufacturing methods and quality specifications developed
04 / INDICATION STRATEGY
Establish human POC in peripheral nerves
then expand to more severe nerve injuries
Severe carpal tunnel syndrome is the clinical entry point, followed by peripheral nerve transection/trauma and spinal cord injury.
[ "indication" : An approved use for any therapeutic intervention or drug.]
Severe carpal tunnel syndrome
A disorder caused by compression of the median nerve. This is the clinical entry indication intended to establish early human POC for SCAD Schwann cells.
Peripheral nerve transection and traumatic injury
Expansion to more severe peripheral nerve injuries, including potential combinations with nerve suturing or nerve conduits.
Spinal cord injury
A central nervous system injury with substantial unmet medical needs. Clinical trials in the peripheral nerve indications will give information for this next expansion.
05 / PRECLINICAL EVIDENCE
Improvement across all evaluated endpoints in animal studies
SCAD Schwann cells were administered in a rat sciatic nerve crush model in collaboration with Kyoto University Medical School. (See reference; Neuroscience Insights, Vol. 21, pp. 1–14, 2026 )
EndpointsNeuropathology, electrophysiology, sensory and motor function, muscle mass, and neuromuscular junction (NMJ) protein levels
4 weeksEvaluation period used to assess improvement
POCFunctional recovery demonstrated in an injured nerve model
06 / MANUFACTURING & QUALITY
Stable manufacturing, quality and cryopreservation
A platform built for clinical delivery
SCAD has developed a stable manufacturing process from ES/iPS cells to mature Schwann cells.
97%+Purity of Schwann cell precursors, based on SOX10 / S100B double positivity
88%+Positivity for MBP, a marker of mature Schwann cells
10¹⁰cells/lotProjected manufacturing scale; approximately 1,000 carpal tunnel syndrome doses per lot
Further development of stable large-scale manufacturing methods is ongoing.
07 / CLINICAL DEVELOPMENT
Advancing toward clinical entry
with regulatory-aligned manufacturing and trial preparation
Discussions, coordination, and preparation are underway toward initiation of an investigator-initiated clinical trial in 2027.
2026PMDA consultationsStepwise consultations on cell quality, safety, and the clinical trial protocol
2026–2027MCB / investigational product manufacturingMaster Cell Bank (MCB) establishment and manufacturing of cells for the clinical trial
2027Investigator-initiated trial preparationBuilding the clinical trial implementation structure centered at Kyoto University Hospital
NEXTIndication expansion / global developmentExpansion to other peripheral nerve injuries and spinal cord injury
FUTURE CONCEPT / SCHWANN CELL–DERIVED EXOSOMES
Harnessing Schwann cell repair biology
through Schwann cell-derived exosomes
In addition to Schwann cell therapy itself, SCAD is exploring the future potential of exosomes, nanoscale particles released by Schwann cells. Exosomes may carry bioactive molecules involved in neuroprotection, axonal growth, angiogenesis, anti-inflammatory activity, and other repair processes.
Because SCAD has established technology for stable, large-scale manufacturing of Schwann cells, we believe the same platform may also support stable, large-scale production of Schwann cell-derived exosomes.
ALSAmyotrophic lateral sclerosis
SCISpinal cord injury
TBITraumatic brain injury
Peripheral neuropathyVarious peripheral neuropathies
Schwann cell-derived exosome therapies have been reported in research involving several neurological diseases and injuries, including ALS; however, this field remains at the research stage worldwide. At SCAD, exosomes are currently being considered as a future prospect.
08 / SCIENCE & PUBLICATIONS
Research & Publications
Journal Publications
Schwann cell-related journal publications reported in SCAD news updates.
2026
Mature Schwann Cells Derived From Human Induced Pluripotent Stem Cells Promote Peripheral Nerve Regeneration In Vivo
Fujita, Ikeguchi, Aoyama, Noguchi, Yoshimoto, Sakamoto, Iwai, Miyamoto, Takeuchi, Nagai-Tanima, Nohara, Tooi, Igura, Kiboku, Okama, Ogasawara, Matsuda
Neuroscience Insights, Vol. 21, pp. 1–14, 2026
DOI: 10.1177/26331055261443172
Fujita, Ikeguchi, Aoyama, Noguchi, Yoshimoto, Sakamoto, Iwai, Miyamoto, Takeuchi, Nagai-Tanima, Nohara, Tooi, Igura, Kiboku, Okama, Ogasawara, Matsuda
Neuroscience Insights, Vol. 21, pp. 1–14, 2026
DOI: 10.1177/26331055261443172
2024
Robust Differentiation of Human Pluripotent Stem Cells into Schwann Cells
Tooi, Okama, Sato, Inose, Ogasawara, Senda, Nakatsuji, Kato, Kiboku, Igura
Biochemical and Biophysical Research Communications, Vol. 729, 150353, 2024
DOI: 10.1016/j.bbrc.2024.150353
Tooi, Okama, Sato, Inose, Ogasawara, Senda, Nakatsuji, Kato, Kiboku, Igura
Biochemical and Biophysical Research Communications, Vol. 729, 150353, 2024
DOI: 10.1016/j.bbrc.2024.150353
2024
Effect of Epineurial Injection of Human Induced Pluripotent Stem Cell-Derived Schwann Cells on Nerve Regeneration in a Rat Sciatic Nerve Crush Injury Model
Fujita, Ikeguchi, Aoyama, Noguchi, Sakamoto, Iwai, Miyamoto, Tanima, Nohara, Kiboku, Okama, Ogasawara, Matsuda
Peripheral Nerve, Vol. 35(2), p. 268, 2024
DOI: Not assigned / Conference abstract published in journal
Fujita, Ikeguchi, Aoyama, Noguchi, Sakamoto, Iwai, Miyamoto, Tanima, Nohara, Kiboku, Okama, Ogasawara, Matsuda
Peripheral Nerve, Vol. 35(2), p. 268, 2024
DOI: Not assigned / Conference abstract published in journal
2024
Generation of Schwann Cells From Human Pluripotent Stem Cells With Potential to Promote Nerve Regeneration
Igura, Tooi, Kiboku, Okama, Sato, Inose, Nakatsuji
Peripheral Nerve, Vol. 35(2), p. 269, 2024
DOI: Not assigned / Conference abstract published in journal
Igura, Tooi, Kiboku, Okama, Sato, Inose, Nakatsuji
Peripheral Nerve, Vol. 35(2), p. 269, 2024
DOI: Not assigned / Conference abstract published in journal
Conference Presentations
Schwann cell-related conference presentations reported in SCAD news updates.
2026.03
Establishment of a Clinical Manufacturing Method and Quality and Safety Evaluation of Human ES Cell-Derived Schwann Cells for the Treatment of Nerve Injury
Kiboku, Igura, Tooi, Okama, Ogasawara, Senda, Takada, Kawase, Nakatsuji
25th Congress of the Japanese Society for Regenerative Medicine, P-11-15 / March 2026
Kiboku, Igura, Tooi, Okama, Ogasawara, Senda, Takada, Kawase, Nakatsuji
25th Congress of the Japanese Society for Regenerative Medicine, P-11-15 / March 2026
2026.03
Evaluation of ES Cell-Derived Schwann Cell Transplantation Therapy in a Rat Sciatic Nerve Crush Model
Aoyama, Shimizu, Toyoda, Fujita, Ogasawara, Senda, Kiboku, Igura, Kawase, Ikeguchi
25th Congress of the Japanese Society for Regenerative Medicine, P-28-31 / March 2026
Aoyama, Shimizu, Toyoda, Fujita, Ogasawara, Senda, Kiboku, Igura, Kawase, Ikeguchi
25th Congress of the Japanese Society for Regenerative Medicine, P-28-31 / March 2026
2025.03
Development of a Manufacturing Method for Clinical-Grade Pluripotent Stem Cell-Derived Schwann Cells and Characterization for Nerve Injury Treatment
Kiboku, Igura, Tooi, Okama, Ogasawara, Senda, Takada, Kawase, Nakatsuji
24th Congress of the Japanese Society for Regenerative Medicine, O-11-2 / March 2025
Kiboku, Igura, Tooi, Okama, Ogasawara, Senda, Takada, Kawase, Nakatsuji
24th Congress of the Japanese Society for Regenerative Medicine, O-11-2 / March 2025
2025.03
Effect of Epineurial Injection of Human Induced Pluripotent Stem Cell-Derived Schwann Cells in a Rat Sciatic Nerve Crush Injury Model
Fujita, Ikeguchi, Aoyama, Noguchi, Okama, Ogasawara, Kiboku, Nakatsuji, Matsuda
24th Congress of the Japanese Society for Regenerative Medicine, O-11-5 / March 2025
Fujita, Ikeguchi, Aoyama, Noguchi, Okama, Ogasawara, Kiboku, Nakatsuji, Matsuda
24th Congress of the Japanese Society for Regenerative Medicine, O-11-5 / March 2025
2024.09
Effect of Epineurial Injection of Human Induced Pluripotent Stem Cell-Derived Schwann Cells on Nerve Regeneration in a Rat Sciatic Nerve Crush Injury Model
Fujita, Ikeguchi, Aoyama, Noguchi, Sakamoto, Iwai, Miyamoto, Tanima, Nohara, Kiboku, Okama, Ogasawara, Matsuda
35th Annual Meeting of the Japanese Peripheral Nerve Society, O-16 / September 2024
Fujita, Ikeguchi, Aoyama, Noguchi, Sakamoto, Iwai, Miyamoto, Tanima, Nohara, Kiboku, Okama, Ogasawara, Matsuda
35th Annual Meeting of the Japanese Peripheral Nerve Society, O-16 / September 2024
2024.09
Generation of Schwann Cells From Human Pluripotent Stem Cells With Potential to Promote Nerve Regeneration
Igura, Tooi, Kiboku, Okama, Sato, Inose, Nakatsuji
35th Annual Meeting of the Japanese Peripheral Nerve Society, O-17 / September 2024
Igura, Tooi, Kiboku, Okama, Sato, Inose, Nakatsuji
35th Annual Meeting of the Japanese Peripheral Nerve Society, O-17 / September 2024
PARTNERSHIP / DEVELOPMENT
Building the next stage of nerve regeneration
together
We welcome partnerships in co-development, clinical development, manufacturing, global expansion, licensing, investment, and other areas that can accelerate the practical development of Schwann cell therapy.
Contact us →