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

Using the Action Research Arm Test for validation is not useful, it is subjective.

I see nothing here that suggests that any objective damage diagnosis was done. Without having a valid starting point this research can't be replicated.

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

1. Keith W Muir1,
2. Diederik Bulters2,
3. Mark Willmot3,
4. Nikola Sprigg4,
5. Anand Dixit5,
6. http://orcid.org/0000-0002-7688-9649Nick Ward6,7,
7. Pippa Tyrrell8,
8. Arshad Majid9,
9. Laurence Dunn10,
10. Philip Bath4,
11. Julian Howell11,
12. Paul Stroemer11,
13. Kenneth Pollock11,
14. John Sinden11

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(So dead brain areas like mine would not be helped.), 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

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http://dx.doi.org/10.1136/jnnp-2019-32251