AI Article Synopsis
- Amyotrophic Lateral Sclerosis (ALS) is an incurable disease, and this study explored the use of mesenchymal stem cell (MSC) transplantation as a potential treatment option.
- The Phase 1 clinical trial involved ten ALS patients and aimed to assess the safety and toxicity of the procedure, with regular follow-ups showing no significant adverse effects or structural changes in the brain or spinal cord.
- While the study confirmed the safety of MSC transplantation, it noted that the effectiveness of the procedure remains uncertain due to the absence of post mortem material to evaluate the vitality of the transplanted cells.
Article Abstract
Amyotrophic Lateral Sclerosis (ALS) is a devastating incurable disease. Stem-cell-based therapies represent a new possible strategy for ALS clinical research. The objectives of this Phase 1 clinical study were to assess the feasibility and toxicity of mesenchymal stem cell transplantation and to test the impact of a cell therapy in ALS patients. The trial was approved and monitored by the National Institute of Health and by the Ethics Committees of all participating Institutions. Autologous MSCs were isolated from bone marrow, expanded in vitro and analyzed according to GMP conditions. Expanded MSCs were suspended in the autologous cerebrospinal fluid (CSF) and directly transplanted into the spinal cord at a high thoracic level with a surgical procedure. Ten ALS patients were enrolled and regularly monitored before and after transplantation by clinical, psychological, neuroradiological and neurophysiological assessments. There was no immediate or delayed transplant-related toxicity. Clinical, laboratory, and radiographic evaluations of the patients showed no serious transplant-related adverse events. Magnetic resonance images (MRI) showed no structural changes (including tumor formation) in either the brain or the spinal cord. However the lack of post mortem material prevents any definitive conclusion about the vitality of the MSCs after transplantation. In conclusion, this study confirms that MSC transplantation into the spinal cord of ALS patients is safe and that MSCs might have a clinical use for future ALS cell based clinical trials.
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| http://dx.doi.org/10.1016/j.expneurol.2009.08.007 | DOI Listing |
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