Intracerebral implantation of human neural stem cells and motor recovery after stroke: multicentre prospective single-arm study (PISCES-2).

Muir, Keith W and Bulters, Diederik and Willmot, Mark and Sprigg, Nikola and Dixit, Anand and Ward, Nick and Tyrrell, Pippa and Majid, Arshad and Dunn, Laurence and Bath, Philip and Howell, Julian and Stroemer, Paul and Pollock, Kenneth and Sinden, John (2020) Intracerebral implantation of human neural stem cells and motor recovery after stroke: multicentre prospective single-arm study (PISCES-2). Journal of neurology, neurosurgery, and psychiatry, 91 (4). pp. 396-401. ISSN 1468-330X. Available through UHB Open Athens

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Abstract

BACKGROUND

Human neural stem cell implantation may offer improved recovery from stroke. We investigated the feasibility of intracerebral implantation of the allogeneic human neural stem cell line CTX0E03 in the subacute-chronic recovery phase of stroke and potential measures of therapeutic response in a multicentre study.

METHODS

We undertook a prospective, multicentre, single-arm, open-label study in adults aged >40 years with significant upper limb motor deficits 2-13 months after ischaemic stroke. 20 million cells were implanted by stereotaxic injection to the putamen ipsilateral to the cerebral infarct. The primary outcome was improvement by 2 or more points on the Action Research Arm Test (ARAT) subtest 2 at 3 months after implantation.

FINDINGS

Twenty-three patients underwent cell implantation at eight UK hospitals a median of 7 months after stroke. One of 23 participants improved by the prespecified ARAT subtest level at 3 months, and three participants at 6 and 12 months. Improvement in ARAT was seen only in those with residual upper limb movement at baseline. Transient procedural adverse effects were seen, but no cell-related adverse events occurred up to 12 months of follow-up. Two deaths were unrelated to trial procedures.

INTERPRETATION

Administration of human neural stem cells by intracerebral implantation is feasible in a multicentre study. Improvements in upper limb function occurred at 3, 6 and 12 months, but not in those with absent upper limb movement at baseline, suggesting a possible target population for future controlled trials.

FUNDING

ReNeuron, Innovate UK (application no 32074-222145).

TRIAL REGISTRATION NUMBER

EudraCT Number: 2012-003482-18.

Item Type:	Article
Additional Information:	Available through UHB Open Athens
Subjects:	WL Nervous system. Neurology
Divisions:	Emergency Services > Neurology
Related URLs:	https://pubmed.ncbi.nlm.nih.gov/32041820...
Depositing User:	Beth Connors
Date Deposited:	24 Aug 2020 12:27
Last Modified:	24 Aug 2020 12:27
URI:	http://www.repository.uhblibrary.co.uk/id/eprint/3377

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