التفاصيل البيبلوغرافية
| العنوان: |
Human neural stem cells in patients with chronic ischaemic stroke (PISCES): a phase 1, first-in-man study. |
| المؤلفون: |
Kalladka, Dheeraj1, Sinden, John2, Pollock, Kenneth2, Haig, Caroline3, McLean, John4, Smith, Wilma1, McConnachie, Alex3, Santosh, Celestine4, Bath, Philip M.5, Dunn, Laurence6, Muir, Keith W.1 keith.muir@glasgow.ac.uk |
| المصدر: |
Lancet. 8/20/2016, Vol. 388 Issue 10046, p787-796. 10p. 2 Black and White Photographs, 1 Diagram, 2 Charts, 2 Graphs. |
| مصطلحات موضوعية: |
*NEURAL stem cells, *STROKE treatment, *CORONARY disease, *MEDICATION safety, *SENSORIMOTOR cortex, *BRAIN imaging, *MAGNETIC resonance imaging, *PATIENTS, *PHYSIOLOGY, *THERAPEUTICS, *RADIOGRAPHY, *BASAL ganglia, *BRAIN, *CEREBRAL ischemia, *CHRONIC diseases, *CLINICAL trials, *COMPARATIVE studies, *COMPUTED tomography, *INFARCTION, *INJECTIONS, *RESEARCH methodology, *MEDICAL cooperation, *RESEARCH, *STEM cells, *STEREOTAXIC techniques, *TIME, *PILOT projects, *EVALUATION research, *TREATMENT effectiveness, *DISEASE complications |
| مصطلحات جغرافية: |
UNITED Kingdom |
| مستخلص: |
Background: CTX0E03 is an immortalised human neural stem-cell line from which a drug product (CTX-DP) was developed for allogeneic therapy. Dose-dependent improvement in sensorimotor function in rats implanted with CTX-DP 4 weeks after middle cerebral artery occlusion stroke prompted investigation of the safety and tolerability of this treatment in stroke patients.Methods: We did an open-label, single-site, dose-escalation study. Men aged 60 years or older with stable disability (National Institutes of Health Stroke Scale [NIHSS] score ≥6 and modified Rankin Scale score 2-4) 6-60 months after ischaemic stroke were implanted with single doses of 2 million, 5 million, 10 million, or 20 million cells by stereotactic ipsilateral putamen injection. Clinical and brain imaging data were collected over 2 years. The primary endpoint was safety (adverse events and neurological change). This trial is registered with ClinicalTrials.gov, number NCT01151124.Findings: 13 men were recruited between September, 2010, and January, 2013, of whom 11 (mean age 69 years, range 60-82) received CTX-DP. Median NIHSS score before implantation was 7 (IQR 6-8) and the mean time from stroke was 29 (SD 14) months. Three men had subcortical infarcts only and seven had right-hemisphere infarcts. No immunological or cell-related adverse events were seen. Other adverse events were related to the procedure or comorbidities. Hyperintensity around the injection tracts on T2-weighted fluid-attenuation inversion recovery MRI was seen in five patients. At 2 years, improvement in NIHSS score ranged from 0 to 5 (median 2) points.Interpretation: Single intracerebral doses of CTX-DP up to 20 million cells induced no adverse events and were associated with improved neurological function. Our observations support further investigation of CTX-DP in stroke patients.Funding: ReNeuron Limited. [ABSTRACT FROM AUTHOR] |
| قاعدة البيانات: |
Academic Search Index |
