ArticleFrontiers in neurology2018
Phase 1 Trial of Amnion Cell Therapy for Ischemic Stroke.
Article in Frontiers in neurology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed, 2 syntheses or guidelines pooled it, 31 citations in OpenAlex.
- Application of human amniotic epithelial cells in regenerative medicine: a systematic review.Stem cell research & therapy · 2020Pooled it
- Stem cell-based therapies for ischemic stroke: a systematic review and meta-analysis of clinical trials.Stem cell research & therapy · 2020Pooled it
- Molecular Pathophysiology of Ischemic Stroke and Mesenchymal Stem Cell Based Therapeutic Strategies for Neural Tissue Regeneration: A Pre-clinical and Clinical Perspective.Stem cell reviews and reports · 2026Review
- Implications of maternal-fetal health on perinatal stem cell banking.Gene therapy · 2024Review
- Reinvesting the cellular properties of human amniotic epithelial cells and their therapeutic innovations.Frontiers in immunology · 2024Review
- The GibcoGene therapy · 2023Review
- Expansion of human amniotic epithelial cells using condition cell reprogramming technology.Human cell · 2023Article
- Phase I trial outcome of amnion cell therapy in patients with ischemic stroke (I-ACT).Frontiers in neuroscience · 2023Article
- Stem cells and COVID-19: are the human amniotic cells a new hope for therapies against the SARS-CoV-2 virus?Stem cell research & therapy · 2021Review
- Characteristics and Therapeutic Potential of Human Amnion-Derived Stem Cells.International journal of molecular sciences · 2021Review
- Crescentic Glomerulonephritis: Pathogenesis and Therapeutic Potential of Human Amniotic Stem Cells.Frontiers in physiology · 2021Review
- A comparative study of Bayesian optimal interval (BOIN) design with interval 3+3 (i3+3) design for phase I oncology dose-finding trials.Statistics in biopharmaceutical research · 2021Article
- Emerging Cellular Therapies for Anti-myeloperoxidase Vasculitis and Other Autoimmune Diseases.Frontiers in immunology · 2021Review
- Multipotency of mouse trophoblast stem cells.Stem cell research & therapy · 2020Article
- Therapeutic Potential of Human Amniotic Epithelial Cells on Injuries and Disorders in the Central Nervous System.Stem cells international · 2019Review
- Cell-Based Therapies for Stroke: Are We There Yet?Frontiers in neurology · 2019Review
- Model-Assisted Designs for Early-Phase Clinical Trials: Simplicity Meets Superiority.JCO precision oncology · 2019Review
- Amnion epithelial cells - a novel therapy for ischemic stroke?Neural regeneration research · 2018Article
- Safety, acceptability, and usability of an immersive gamification technology system for use in patients with behavioral and psychological symptoms of dementia (phase 1 trial).Journal of Alzheimer's disease reportsArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThere is increasing interest in stem cell therapy as another treatment modality in stroke, particularly for patients who are unable to receive endovascular clot retrieval or thrombolysis therapies, or for whom standard treatment has failed. We have recently shown that human amniotic epithelial cells (hAECs) are effective in reducing infarct volume in different animal models of ischemic stroke, including in non-human primates. hAEC therapy attenuated infarct growth and/or promoted functional recovery, even when administered 1-3 days after the onset of stroke.
methodsWe now propose an open label Phase 1 dose escalation trial to assess the safety of allogeneic hAECs in stroke patients with a view to providing an evidence platform for future Phase 2 efficacy trials. We propose a modified 3 + 3 dose escalation study design with additional components for measuring magnetic resonance signal of efficacy as well as the effect of hAECs on immunosuppression after stroke.
resultThe trial will commence in 2018. The findings will be published in a peer-reviewed journal.
conclusionThe trial is registered with ANZCTR (ACTRN12618000076279p).
Indexed as
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.