ArticleJournal of translational medicine2015
Human neural stem cell transplantation in ALS: initial results from a phase I trial.
Article in Journal of translational medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 93 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Intra-spinal Cord Delivery of Human Neural Stem Cells in ALS Patients: Proposal for a Phase I Study/ Trapianto Intramidollare di Cellule Staminali Neurali Umane Come Terapia Putativa Per la SLA: Proposta di un Trial Clinico di Fase I
A Phase I Multicenter Study of Allogenic, Intracerebroventricular Human Neural Stem Cells Transplantation for the Experimental Treatment of Secondary Progressive Multiple Sclerosis Patients
Who cites it
93 citing papers in PubMed, 3 syntheses or guidelines pooled it, 203 citations in OpenAlex.
- Neural Stem/Progenitor Cell Therapy in Patients and Animals with Amyotrophic Lateral Sclerosis: A Systematic Review and Meta-analysis.Molecular neurobiology · 2025Pooled it
- Cell-based therapies for amyotrophic lateral sclerosis/motor neuron disease.The Cochrane database of systematic reviews · 2019Pooled it
- Cell-based therapies for amyotrophic lateral sclerosis/motor neuron disease.The Cochrane database of systematic reviews · 2016Pooled it
- Safety and efficacy of first-in-man intrathecal injection of human astrocytes (AstroRx®) in ALS patients: phase I/IIa clinical trial results.Journal of translational medicine · 2023Trial
- Regenerative strategies for ALS: stem cells and extracellular vesicles.Discover nano · 2026Review
- Metallothionein and neurodegenerative diseases.Neural regeneration research · 2026Article
- Advancing regenerative medicine with RNA nanotechnology for chronic and end organ diseases.Communications medicine · 2026Review
- Review
- Molecular and functional characterization of GMP-manufactured neural stem cells and their extracellular vesicles for innovative therapeutic applications.Stem cell research & therapy · 2026Article
- A conserved bioelectrical signature defines subventricular zone-derived human fetal neural stem cells and tracks their differentiation state.Frontiers in cell and developmental biology · 2026Article
- The Effectiveness Based on Optimal Dose and Administration Route, and Safety Profiles of Stem Cells and Derived Products in the Treatment of Patients With Amyotrophic Lateral Sclerosis: A Systematic Review and Meta-Analysis.Stem cells international · 2026Review
- Clinical Efficacy of Stem Cell Therapy in Neurotraumatic and Neurodegenerative Conditions: A Comparative Review.Tissue engineering and regenerative medicine · 2025Review
- Cutting-edge treatments in amyotrophic lateral sclerosis: the role of molecular pathogenesis in targeted therapies.Stem cell research & therapy · 2025Review
- Dual SMAD inhibition as a versatile platform in human pluripotent stem cell-based regenerative medicine and disease modeling.Molecules and cells · 2025Review
- Neural Stem Cell-Derived Extracellular Vesicles for Advanced Neural Repair.Journal of neurochemistry · 2025Review
- Safety and efficacy evaluation of intracerebroventricular human neural stem cell transplantation in SOD1 mice as a novel approach for ALS.Journal of translational medicine · 2025Article
- Review
- Cell-based regenerative and rejuvenation strategies for treating neurodegenerative diseases.Stem cell research & therapy · 2025Review
- Mapping the global clinical landscape of stem cell therapies for neurological diseases from 1998 to 2023: an analysis based on the Trialtrove database.Stem cell research & therapy · 2025Article
- Role of Oligodendrocyte Lineage Cells in White Matter Injury.Advances in neurobiology · 2025Review
33 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
41 authors at 9 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundWe report the initial results from a phase I clinical trial for ALS. We transplanted GMP-grade, fetal human neural stem cells from natural in utero death (hNSCs) into the anterior horns of the spinal cord to test for the safety of both cells and neurosurgical procedures in these patients. The trial was approved by the Istituto Superiore di Sanità and the competent Ethics Committees and was monitored by an external Safety Board.
methodsSix non-ambulatory patients were treated. Three of them received 3 unilateral hNSCs microinjections into the lumbar cord tract, while the remaining ones received bilateral (n = 3 + 3) microinjections. None manifested severe adverse events related to the treatment, even though nearly 5 times more cells were injected in the patients receiving bilateral implants and a much milder immune-suppression regimen was used as compared to previous trials.
resultsNo increase of disease progression due to the treatment was observed for up to18 months after surgery. Rather, two patients showed a transitory improvement of the subscore ambulation on the ALS-FRS-R scale (from 1 to 2). A third patient showed improvement of the MRC score for tibialis anterior, which persisted for as long as 7 months. The latter and two additional patients refused PEG and invasive ventilation and died 8 months after surgery due to the progression of respiratory failure. The autopsies confirmed that this was related to the evolution of the disease.
conclusionsWe describe a safe cell therapy approach that will allow for the treatment of larger pools of patients for later-phase ALS clinical trials, while warranting good reproducibility. These can now be carried out under more standardized conditions, based on a more homogenous repertoire of clinical grade hNSCs. The use of brain tissue from natural miscarriages eliminates the ethical concerns that may arise from the use of fetal material.
trial registrationEudraCT:2009-014484-39 .
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.