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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

Randomised placebo-controlled multicentre trial to evaluate the efficacy and safety of JTR-161, allogeneic human dental pulp stem cells, in patients with Acute Ischaemic stRoke (J-REPAIR)
Introduction JTR-161 is a novel allogeneic human cell product consisting of dental pulp stem cells isolated from the extracted teeth of healthy adults. It is currently under development as a cell-based therapy for ischaemic stroke. The aim of this study is to evaluate the safety and efficacy of JTR-161 in patients with acute ischaemic stroke when given as a single intravenous administration within 48 hours of symptom onset. Methods and analysis This is a first-in-human, randomised, double-blind, placebo-controlled, multicentre, phase 1/2 clinical trial to be conducted in Japan (from January 2019 to July 2021). Patients wi...
Source: BMJ Open - May 24, 2022 Category: General Medicine Authors: Suda, S., Nito, C., Ihara, M., Iguchi, Y., Urabe, T., Matsumaru, Y., Sakai, N., Kimura, K., on behalf of the J- REPAIR trial group, Okubo, Takeuchi, Takao, Takahashi, Morimoto, Akaiwa, Ishii, Kanzawa, Kanai, Yoshimura, Hara, Tsujino, Kamatsuka, Inoue, Iwa 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

Cell therapy for cerebral hemorrhage: Five year follow-up report.
Authors: Chang Z, Mao G, Sun L, Ao Q, Gu Y, Liu Y Abstract The aim of the study was to examine treatment of cerebral hemorrhages with bone-marrow or human umbilical cord-derived mesenchymal stem cells (BMSCs or Hu-MSCs) and conventional surgical approaches, and determine and compare the effectiveness, feasibility, safety and reproducibility of each method. A retrospective analysis was performed on a cohort of cell-treated cerebral hemorrhage patients from October 1, 2007 to October 1, 2009. A total of 24 patients, all of whom received conventional surgical treatment, were classified as follows: i) The control group...
Source: Experimental and Therapeutic Medicine - January 20, 2017 Category: Journals (General) Tags: Exp Ther Med Source Type: research

Human neural stem cells in patients with chronic ischaemic stroke (PISCES): a phase 1, first-in-man study
Publication date: Available online 3 August 2016 Source:The Lancet Author(s): Dheeraj Kalladka, John Sinden, Kenneth Pollock, Caroline Haig, John McLean, Wilma Smith, Alex McConnachie, Celestine Santosh, Philip M Bath, Laurence Dunn, Keith W Muir 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 ...
Source: The Lancet - August 3, 2016 Category: Journals (General) Source Type: research