Amyotrophic Lateral Sclerosis Clinical Trial
Official title:
The Evaluation of the Effect of Wharton's Jelly Mesenchymal Stem Cells (WJMSCs) on the Immune System of Patients With Amyotrophic Lateral Sclerosis (ALS)
The objective of this study is to evaluate the safety of intrathecal administration of Wharton's Jelly Mesenchymal Stem Cells (WJMSC) and the impact on the immune system of patients with Amyotrophic Lateral Sclerosis.
Clinical Phase: I/II Population: Patients with Amyotrophic Lateral Sclerosis. Project Design: One arm, non-blinded, open label study Planned Sample Size: 20 patients Investigational Medicinal Product: active IMP - mesenchymal stem cells isolated from Wharton's jelly Screening: Three visits on site to check the eligibility criteria (around 90, 60 and 30 days before first IMP administration) Treatment (IMP administration): Each patient will receive IMP three times: on baseline (day 0), 30 and 60 days after baseline (+/- 7 days). Administration route: intrathecal Follow up: Duration: 18 months after first IMP administration Four on-site visits (3, 6, 9, 12 months after first IMP administration) and seven phone visits (4, 5, 7, 8, 10, 11 and 18 months after first IMP administration) ;
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