ArticleScientific reports2016
Neural Stem Cell Tumorigenicity and Biodistribution Assessment for Phase I Clinical Trial in Parkinson's Disease.
Article in Scientific reports, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02452723 (A Single Arm, Open-Label Phase 1 Study to Evaluate the Safety and Tolerability of ISC-hpNSC Injected Into the Striatum and Substantia Nigra of Patients With Parkinson's Disease), which is not on this map. Cited by 44 papers.
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.
A Single Arm, Open-Label Phase 1 Study to Evaluate the Safety and Tolerability of ISC-hpNSC Injected Into the Striatum and Substantia Nigra of Patients With Parkinson's Disease
Who cites it
44 citing papers in PubMed, 73 citations in OpenAlex.
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- Advances in brain remodeling, stem cell therapies, and translational barriers in stroke and brain aging.Biogerontology · 2025Review
- Current Applications of Human Pluripotent Stem Cells in Neuroscience Research and Cell Transplantation Therapy for Neurological Disorders.Stem cell reviews and reports · 2025Review
- Engineering aortic valves via transdifferentiating fibroblasts into valvular endothelial cells without using viruses or iPS cells.Bioactive materials · 2025Article
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- Characteristics of Parthenogenetic Stem Cells and Their Potential Treatment Strategy for Central Nervous System Diseases.Neuropsychiatric disease and treatment · 2025Review
- The Abnormal Proliferation of Midbrain Dopamine Cells From Human Pluripotent Stem Cells Is Induced by Exposure to the Tumor Microenvironment.CNS neuroscience & therapeutics · 2024Article
- A tumorigenicity evaluation platform for cell therapies based on brain organoids.Translational neurodegeneration · 2024Article
- Detection of residual pluripotent stem cells in cell therapy products utilizing droplet digital PCR: an international multisite evaluation study.Stem cells translational medicine · 2024Article
- Cell therapy for neurological disorders.Nature medicine · 2024Review
- Research progress of neural stem cells as a source of dopaminergic neurons for cell therapy in Parkinson's disease.Molecular biology reports · 2024Review
- Neuro-regeneration or Repair: Cell Therapy of Neurological Disorders as A Way Forward.Current neuropharmacology · 2024Review
- Transplantation of human neural stem cell prevents symptomatic motor behavior disability in a rat model of Parkinson's disease.Open life sciences · 2024Article
- Cell Replacement Therapy for Brain Repair: Recent Progress and Remaining Challenges for Treating Parkinson's Disease and Cortical Injury.Brain sciences · 2023Review
- Challenges in the clinical advancement of cell therapies for Parkinson's disease.Nature biomedical engineering · 2023Review
- Neural stem/progenitor cell-derived extracellular vesicles: A novel therapy for neurological diseases and beyond.MedComm · 2023Review
- From 2D to 3D: Development of Monolayer Dopaminergic Neuronal and Midbrain Organoid Cultures for Parkinson's Disease Modeling and Regenerative Therapy.International journal of molecular sciences · 2023Review
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Human pluripotent stem cells (PSC) have the potential to revolutionize regenerative medicine. However undifferentiated PSC can form tumors and strict quality control measures and safety studies must be conducted before clinical translation. Here we describe preclinical tumorigenicity and biodistribution safety studies that were required by the US Food and Drug Administration (FDA) and Australian Therapeutic Goods Administration (TGA) prior to conducting a Phase I clinical trial evaluating the safety and tolerability of human parthenogenetic stem cell derived neural stem cells ISC-hpNSC for treating Parkinson's disease (ClinicalTrials.gov Identifier NCT02452723). To mitigate the risk of having residual PSC in the final ISC-hpNSC population, we conducted sensitive in vitro assays using flow cytometry and qRT-PCR analyses and in vivo assays to determine acute toxicity, tumorigenicity and biodistribution. The results from these safety studies show the lack of residual undifferentiated PSC, negligible tumorigenic potential by ISC-hpNSC and provide additional assurance to their clinical application.
Identifiers
What OpenQuestion holds
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.