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Efficacy and safety of human-derived neural stem cell in patients with ischaemic stroke: study protocol for a randomised controlled trial
Introduction Stroke is the most common cause of neurological disability in adults worldwide. Neural stem cell (NSC) transplantation has shown promising results as a treatment for stroke in animal experiments. The pilot investigation of stem cells in stroke phase 1 and phase 2 trials showed that transplantation of the highest dose (20 million cells) was well tolerated. Preliminary clinical benefits have also been observed. However, the trials were open-label and had a small sample size. Furthermore, human NSCs (hNSCs) were intracerebrally implanted, and some serious adverse events were considered to be related to the surgic...
Source: BMJ Open - November 8, 2022 Category: General Medicine Authors: Xie, C., Wang, K., Peng, J., Jiang, X., Pan, S., Wang, L., Wu, Y., Guan, Y. Tags: Open access, Neurology Source Type: research

Allogeneic adipose tissue-derived mesenchymal stem cells in ischaemic stroke (AMASCIS-02): a phase IIb, multicentre, double-blind, placebo-controlled clinical trial protocol
Introduction Stroke is a serious public health problem, given it is a major cause of disability worldwide despite the spread of recanalisation therapies. Enhancement of brain plasticity with stem cell administration is a promising innovative therapy to reduce sequelae in these patients. Methods and analysis We have developed a phase IIb, multicentre, randomised, double-blind, placebo-controlled clinical trial protocol to evaluate the safety and efficacy of intravenous administration of allogeneic adipose tissue-derived mesenchymal stem cells (AD-MSCs) in patients with acute ischaemic stroke, concurrently with conventional...
Source: BMJ Open - August 9, 2021 Category: General Medicine Authors: de Celis-Ruiz, E., Fuentes, B., Moniche, F., Montaner, J., Borobia, A. M., Gutierrez-Fernandez, M., Diez-Tejedor, E. Tags: Open access, Neurology Source Type: research