Evidence map›Paper›PMID 27497862›Full record

ArticleLancet (London, England)2016

Human neural stem cells in patients with chronic ischaemic stroke (PISCES): a phase 1, first-in-man study.

Dheeraj Kalladka, John Sinden, Kenneth Pollock, Caroline Haig, John McLean, Wilma Smith, Alex McConnachie, Celestine Santosh, Philip M Bath, Laurence Dunn and 1 more

Registry-linked trialAbstract readClinical Trial, Phase I
PubMed Publisher
In one paragraph

Article in Lancet (London, England), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01151124 (A Phase I Safety Trial of CTX0E03 Drug Product Delivered Intracranially in the Treatment of Patients With Stable Ischemic Stroke), which is not on this map. Cited by 256 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
256citing papers in PubMed, 9 pooled it
27.3field-weighted citation impact, top 1% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT01151124 phase1completednot on this map

A Phase I Safety Trial of CTX0E03 Drug Product Delivered Intracranially in the Treatment of Patients With Stable Ischemic Stroke

TypeinterventionalSponsorReNeuron LimitedRan2010 to 2022Enrolled11ConditionsStrokeArmsCTX0E03 neural stem cells
3 · Its place in the literature

Who cites it

256 citing papers in PubMed, 9 syntheses or guidelines pooled it, 400 citations in OpenAlex.

  1. Safety and efficacy of bone marrow mononuclear cell therapy for ischemic stroke recovery: a systematic review and meta-analysis of randomized controlled trials.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2024
    Pooled it
  2. A review and meta-analysis of stem cell therapies in stroke patients: effectiveness and safety evaluation.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2024
    Pooled it
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  7. Stem cell transplantation for ischemic stroke.The Cochrane database of systematic reviews · 2019
    Pooled it
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  20. How deep is your recovery? Rethinking true motor recovery versus compensation in neurorehabilitation.International journal of rehabilitation research. Internationale Zeitschrift fur Rehabilitationsforschung. Revue internationale de recherches de readaptation · 2026
    Review

196 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 4 institutions in 1 country.

Dheeraj KalladkaInstitute of Neuroscience and Psychology, University of Glasgow, Queen Elizabeth University Hospital, Glasgow, UK.
John SindenReNeuron Ltd, Surrey Research Park, Guildford, Surrey, UK.
Kenneth PollockReNeuron Ltd, Surrey Research Park, Guildford, Surrey, UK.
Caroline HaigRobertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.
John McLeanDepartment of Neuroradiology, University of Glasgow, Queen Elizabeth University Hospital, Glasgow, UK.
Wilma SmithInstitute of Neuroscience and Psychology, University of Glasgow, Queen Elizabeth University Hospital, Glasgow, UK.
Alex McConnachieRobertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.
Celestine SantoshDepartment of Neuroradiology, University of Glasgow, Queen Elizabeth University Hospital, Glasgow, UK.
Philip M BathStroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.
Laurence DunnNeurosurgery, Institute of Neurological Sciences, University of Glasgow, Queen Elizabeth University Hospital, Glasgow, UK.
Keith W MuirInstitute of Neuroscience and Psychology, University of Glasgow, Queen Elizabeth University Hospital, Glasgow, UK. Electronic address: keith.muir@glasgow.ac.uk.
Queen Elizabeth University Hospital · GBUniversity of Glasgow · GBReNeuron (United Kingdom) · GBUniversity of Nottingham · GB

Funding

Medical Research Council MR/N003403/1
6 · The paper itself

Abstract

backgroundCTX0E03 is an immortalised human neural stem-cell line from which a drug product (CTX-DP) was developed for allogeneic therapy. Dose-dependent improvement in sensorimotor function in rats implanted with CTX-DP 4 weeks after middle cerebral artery occlusion stroke prompted investigation of the safety and tolerability of this treatment in stroke patients.

methodsWe did an open-label, single-site, dose-escalation study. Men aged 60 years or older with stable disability (National Institutes of Health Stroke Scale [NIHSS] score ≥6 and modified Rankin Scale score 2-4) 6-60 months after ischaemic stroke were implanted with single doses of 2 million, 5 million, 10 million, or 20 million cells by stereotactic ipsilateral putamen injection. Clinical and brain imaging data were collected over 2 years. The primary endpoint was safety (adverse events and neurological change). This trial is registered with ClinicalTrials.gov, number NCT01151124.

findings13 men were recruited between September, 2010, and January, 2013, of whom 11 (mean age 69 years, range 60-82) received CTX-DP. Median NIHSS score before implantation was 7 (IQR 6-8) and the mean time from stroke was 29 (SD 14) months. Three men had subcortical infarcts only and seven had right-hemisphere infarcts. No immunological or cell-related adverse events were seen. Other adverse events were related to the procedure or comorbidities. Hyperintensity around the injection tracts on T2-weighted fluid-attenuation inversion recovery MRI was seen in five patients. At 2 years, improvement in NIHSS score ranged from 0 to 5 (median 2) points.

interpretationSingle intracerebral doses of CTX-DP up to 20 million cells induced no adverse events and were associated with improved neurological function. Our observations support further investigation of CTX-DP in stroke patients.

fundingReNeuron Limited.

Indexed as

Neural Stem CellsPutamenAgedAged, 80 and overBrainBrain IschemiaCerebral InfarctionChronic DiseaseDiffusion Tensor ImagingFeasibility StudiesHumansInjectionsMagnetic Resonance ImagingMaleMiddle AgedPilot Projects

Identifiers

PMID27497862
OpenAlexW2490585184

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.