Potential Use of Autologous and Allogeneic Mesenchymal Stem Cells in Patients With Multiple System Atrophy

Plain-language summary

The prevalence of Multiple System Atrophy (MSA) is reported to be between 3.4 - 4.9 cases per 100,000 population. The estimated average incidence is 0.6 - 0.7 cases per 100,000 people per year. Many patients are not diagnosed properly during their lifetime because of the difficulty in differentiating MSA from other disorders. Approximately 29 - 33% of patients with isolated late onset cerebellar ataxia and 8 - 10% of patients with parkinsonism will develop MSA. There are currently no therapies that can cure or stop the progression of the disease. The current pharmacological therapy is only to relieve symptoms. Mesenchymal stem cells (MSC) are considered an efficient source of cells for therapy, because they can be safely harvested and transplanted to donors or patients, have low immunogenicity, and have broad therapeutic potential. Results from preliminary preclinical and clinical trials indicate the potential of MSC-based treatment in meeting several key aspects of neurodegeneration. Stem cell-based therapy for neurodegenerative diseases aims to stop clinical damage by regenerating and by providing local support for damaged tissue, in addition after transplantation, MSCs have been shown to be capable of penetrating the lesion area and thus have great potential use as a means of administering therapeutic agents. The subjects of this study were patients who experienced possible MSA based on the consensus clinical criteria for MSA. There will be three treatment groups with a total sample of 5 subjects each. Group 1 will receives MSC-Adipose Autologous with doses 2x50 million cells intratechally. Group 2 will receives MSC-Umbilical Cord Allogeneic with doses 2x 50 million cells intratechally. Group 3 will receives MSC-Umbilical Cord Allogeneic with doses 2x50 million cells intratechally and 2x10cc secretome MSC from Adipose Intravenously. Clinical improvement will be evaluated using the UMSARS scale, PET-Scans, MRI, DaTScan, IGF-1, BDNF, Sympathetic skin respons (SSR), EMG, Composite Autonomic Severity Score (CASS), High definition-Optical coherence tomography (HD-OCT), ERG, VEP, Log MAR chart, Ishihara test and side adverse effect on MSC. This study is divided into six timeframes : Before an implantation, First Month after second implantation, Third month after secondary implantation, Sixth month after second implantation, Ninth month after second implantation and Twelve month after second implantation. The differences between the test variables are then used as an indicator to assess clinical improvement within the subjects.

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