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Human spinal cord stem cells.
Human spinal cord stem cells. is a Small molecule drug developed by Neuralstem Inc.. It is currently in Phase 1 development. Also known as: spinal cord injury (SCI).
Human spinal cord stem cells have been studied in clinical trials for the treatment of spinal cord injury, with interventions including intravenous and intrathecal administration of human umbilical cord tissue-derived mesenchymal stem cells and bone marrow mononuclear cells. The mechanism of action of these cells is classified as somatic cell supplemental therapy, according to ChEMBL.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Human spinal cord stem cells. |
|---|---|
| Also known as | spinal cord injury (SCI) |
| Sponsor | Neuralstem Inc. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Extracellular Vesicles for the Treatment of Syringomyelia (PHASE1)
- Efficacy of iPSC-Derived Motor Neuron Cells (XS228) in Subacute Spinal Cord Injury: A Phase II Randomized Controlled Trial (PHASE2)
- Safety and Early Efficacy of iPSC-Derived Motor Neuron Progenitor Cells (XS228) in Subacute Spinal Cord Injury: A Phase I Trial (PHASE1)
- Safety and Exploratory Efficacy of Transplantation Therapy Using PSA-NCAM(+) NPC in AIS-A Level of Sub-acute SCI (PHASE1, PHASE2)
- Stem Cell Spinal Cord Injury Exoskeleton and Virtual Reality Treatment Study (NA)
- Study to Investigate the Safety of the Transplantation of Human Glial Restricted Progenitor Cells Into Subjects With Transverse Myelitis (PHASE1, PHASE2)
- CNS10-NPC-GDNF for the Treatment of ALS (PHASE1)
- Repeated Subarachnoid Administrations of hUC-MSCs in Treating SCI (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Human spinal cord stem cells. CI brief — competitive landscape report
- Human spinal cord stem cells. updates RSS · CI watch RSS
- Neuralstem Inc. portfolio CI
Frequently asked questions about Human spinal cord stem cells.
What is Human spinal cord stem cells.?
Who makes Human spinal cord stem cells.?
Is Human spinal cord stem cells. also known as anything else?
What development phase is Human spinal cord stem cells. in?
Related
- Manufacturer: Neuralstem Inc. — full pipeline
- Also known as: spinal cord injury (SCI)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing