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Open Access Review Issue
Clinical neurorestorative progresses in cerebral palsy
Journal of Neurorestoratology 2017, 5 (1): 51-57
Published: 23 February 2017
Downloads:9

Cerebral palsy (CP), group of permanent nonprogressive clinical disorders in children, is caused by damage to the immature brain. Conventionally available treatments for CP are mainly targeted toward management of its symptoms. With the upcoming field of neurorestorative strategies, we are now able to repair the core brain damage in CP. There are various drugs, stem cells, etc, which have been implicated to have neurorestorative properties. Autologous bone marrow stem cells, umbilical cord stem cells, neural stem cells, and olfactory ensheathing cells have shown the safety and efficacy in preliminary studies. Here, we review the different medicines and cell types that have shown beneficial effects in clinical studies. We propose that combination strategies may be the future of neurorestoration.

Open Access Review Issue
Rethinking on ethics and regulations in cell therapy as part of neurorestoratology
Journal of Neurorestoratology 2016, 4 (1): 1-14
Published: 11 January 2016
Downloads:13

Ethics, regulations, and evidence-based practices form the foundation of modern medicine. However, in recent years, and particularly in reference to cellular therapy, they have become obstacles to the growth and development of this new form of treatment. Based on four important documents, it is proposed that regulatory bodies and medical associations recommend an alternate way of looking at regulations for cell therapy, so as to ensure that only safe and effective treatments are offered to patients, and that greater availability of these new treatment options is also encouraged. The four documents on which these recommendations are based are: 1) World Medical Association Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects; 2) The International Society for Cellular Therapy “White paper” published in 2010; 3) The Beijing Declaration of the International Association of Neurorestoratology; and 4) New legislation passed in Japan in 2014 on regenerative medicine. These recommendations are: greater permissiveness for the use of cell therapy in incurable conditions, identify legitimate cell therapy services, promote medical innovation, respect the rights of patients to choose treatments, recognize the valid compassionate use of unapproved therapies, recognize the significance of small functional gains, give importance to practice-based evidence and existing published literature, have differing regulations for the different types of cell therapies, and adapt the new Japanese legislation for regenerative medicine.

Open Access Original Research Issue
Detailed analysis of the clinical effects of cell therapy for thoracolumbar spinal cord injury: an original study
Journal of Neurorestoratology 2013, 1 (1): 13-22
Published: 25 July 2013
Downloads:11
Background:

Cell therapy is amongst the most promising treatment strategies in spinal cord injury (SCI) because it focuses on repair. There are many published animal studies and a few human trials showing remarkable results with various cell types. The level of SCI determines whether paraplegia or quadriplegia is present, and greatly influences recovery. The purpose of this study was to determine the significance of the clinical effects and long-term safety of intrathecal administration of autologous bone marrow-derived mononuclear cells, along with changes in functional independence and quality of life in patients with thoracolumbar SCI.

Methods:

We undertook a retrospective analysis of a clinical study in which a nonrandomized sample of 110 patients with thoracolumbar SCI underwent autologous bone marrow-derived mononuclear cell transplantation intrathecally and subsequent neurorehabilitation, with a mean follow-up of 2 years ± 1 month. Changes on any parameters were recorded at follow-up. The data were analyzed using the Wilcoxon’s signed-rank test and McNemar’s test. Functional Independence Measure and American Spinal Injury Association (ASIA) scores were recorded, and a detailed neurological assessment was performed.

Results:

Overall improvement was seen in 91% of patients, including reduction in spasticity, partial sensory recovery, and improvement in trunk control, postural hypotension, bladder management, mobility, activities of daily living, and functional independence. A significant association of these symptomatic improvements with the cell therapy intervention was established by the statistical analysis. Some patients showed a shift on the ASIA scale and changes in electrophysiological studies or functional magnetic resonance imaging. No major side effects were noted.

Conclusion:

In patients with thoracolumbar SCI, there were statistically significant beneficial effects, both symptomatic and functional, from intrathecal autologous bone marrow-derived mononuclear cell therapy and rehabilitation. This was a safe and viable therapeutic option with no long-term side effects at 2 years. This analytical study is an early documentation of cell therapy, and can be used as a guide to devise larger more refined clinical trials.

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