Stroke. 2009;40:S149-S151
Published online before print December 8, 2008,
doi: 10.1161/STROKEAHA.108.533208
(Stroke. 2009;40:S149.)
© 2009 American Heart Association, Inc.
Clinical Trials of Stroke Therapy
Which Cells, Which Patients?
Lawrence R. Wechsler, MD
From the UPMC Stroke Institute, Department of Neurology, University of Pittsburgh Medical School, Pittsburgh, Pa.
Correspondence to Lawrence R. Wechsler, MD, Director, UPMC Stroke Institute, Professor of Neurology, University of Pittsburgh Medical School, C426 PUH, 200 Lothrop St, Pittsburgh, PA 15217. E-mail wechslerLR@upmc.edu
Key Words: clinical trials stroke therapy
An extract of the first 250 words of the full text is provided, because this article has no abstract.
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Introduction
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Despite recent advances in stroke prevention and acute stroke
therapy, few treatments exist for reversal of fixed neurological
deficits after stroke. Cellular therapy offers the possibility
of improving neurological deficits months or even years after
stroke. Animal studies provide evidence that such treatment
may be effective. Many questions, however, remain unanswered
regarding cellular therapy for stroke. In view of the significant
differences between animal models and human stroke, some questions
might be best addressed with clinical trials.
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Clinical Trials of Cellular Therapy
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Completed clinical trials of cellular therapy for stroke are
summarized in the Table. Kondziolka et al reported the results
of a Phase I study of 12 patients with completed stroke involving
the basal ganglia treated with human neuronal cells derived
from an immortalized tumor cell line (LBS cells).
1 Either 2
or 6 million cells were implanted stereotactically between 6
months and 6 years after stroke. Patients were followed clinically
as well as with MRI and positron emission tomography scans.
The same group subsequently performed a Phase II study with
randomization of 18 patients to either implantation of 5 or
10 million cells and rehabilitation (14 patients) or rehabilitation
alone (4 patients).
2 Follow-up neurological evaluations were
blinded to treatment status. Savitz et al reported the results
of transplantation of fetal porcine cells implanted stereotactically
in 5 patients with basal ganglia stroke 3 months to 10 years
after onset.
3 The study was discontinued due to adverse events
in 2 patients. In a study by Bang et al, autologous mesenchymal
stem cells were given intravenously
. . . [Full Text of this Article]