http://www.ncbi.nlm.nih.gov/pubmed/25107583
Banerjee S1, Bentley P2, Hamady M2, Marley S2, Davis J2, Shlebak A2, Nicholls J2, Williamson DA2, Jensen SL2, Gordon M2, Habib N2, Chataway J2.
Abstract
Treatment
with CD34+ hematopoietic stem/progenitor cells has been shown to
improve functional recovery in nonhuman models of ischemic stroke via
promotion of angiogenesis and neurogenesis. We aimed to determine the
safety and feasibility of treatment with CD34+ cells delivered
intra-arterially in patients with acute ischemic stroke. This was the
first study in human subjects. We performed a prospective,
nonrandomized, open-label, phase I study of autologous, immunoselected
CD34+ stem/progenitor cell therapy in patients presenting within 7 days
of onset with severe anterior circulation ischemic stroke (National
Institutes of Health Stroke Scale [NIHSS] score ≥8). CD34+ cells were
collected from the bone marrow of the subjects before being delivered by
catheter angiography into the ipsilesional middle cerebral artery.
Eighty-two patients with severe anterior circulation ischemic stroke
were screened, of whom five proceeded to treatment. The common reasons
for exclusion were age >80 years (n = 19); medical instability (n =
17), and significant carotid stenosis (n = 13). The procedure was well
tolerated in all patients, and no significant treatment-related adverse
effects occurred. All patients showed improvements in clinical
functional scores (Modified Rankin Score and NIHSS score) and reductions
in lesion volume during a 6-month follow-up period. Autologous CD34+
selected stem/progenitor cell therapy delivered intra-arterially into
the infarct territory can be achieved safely in patients with acute
ischemic stroke. Future studies that address eligibility criteria,
dosage, delivery site, and timing and that use surrogate imaging markers
of outcome are desirable before larger scale clinical trials.
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