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)
- Keith W Muir1,
- Diederik Bulters2,
- Mark Willmot3,
- Nikola Sprigg4,
- Anand Dixit5,
- http://orcid.org/0000-0002-7688-9649Nick Ward6,7,
- Pippa Tyrrell8,
- Arshad Majid9,
- Laurence Dunn10,
- Philip Bath4,
- Julian Howell11,
- Paul Stroemer11,
- Kenneth Pollock11,
- 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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