Treatment of Spinocerebellar Ataxia with Mesenchymal Stem Cells: A Phase I/IIa Clinical Study

Ataxia is one of the most devastating symptoms of many neurodegenerative disorders. As of today, there is not any effective treatment to retard its progression. Mesenchymal stem cells (MSCs) have shown promise in treating neurodegenerative diseases. We hereby report the results of a phase I/IIa clin...

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Published inCell transplantation Vol. 26; no. 3; pp. 503 - 512
Main Authors Tsai, Yun-An, Liu, Ren-Shyan, Lirng, Jiing-Feng, Yang, Bang-Hung, Chang, Chin-Hao, Wang, Yi-Chen, Wu, Yu-Shan, Ho, Jennifer Hui-Chun, Lee, Oscar K., Soong, Bing-Wen
Format Journal Article
LanguageEnglish
Published Los Angeles, CA SAGE Publications 01.03.2017
Sage Publications Ltd
SAGE Publishing
Subjects
Adipose tissue
Adult
Aged
Ataxia
Atrophy
Body weight
Brain - pathology
Cells, Cultured
Cerebellum
Clinical trials
Double-Blind Method
Female
Glucose metabolism
Humans
Injection
Intravenous administration
Machado-Joseph disease
Magnetic Resonance Spectroscopy
Male
Mesenchymal Stem Cell Transplantation - methods
Mesenchymal stem cells
Metabolites
Middle Aged
Neurodegenerative diseases
Patients
Positron emission tomography
Spinocerebellar ataxia
Spinocerebellar Ataxias - therapy
Stem cells
Transplantation, Homologous - methods
Urinalysis
Young Adult
Clinical trials
Gait disorders/ataxia
Allogeneic mesenchymal stem cells (MSCs)
Trinucleotide repeat diseases
Spinocerebellar ataxias (SCAs)
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Abstract Ataxia is one of the most devastating symptoms of many neurodegenerative disorders. As of today, there is not any effective treatment to retard its progression. Mesenchymal stem cells (MSCs) have shown promise in treating neurodegenerative diseases. We hereby report the results of a phase I/IIa clinical study conducted in Taiwan to primarily evaluate the safety, tolerability, and, secondarily, the possible efficacy of intravenous administration of allogeneic adipose tissue-derived MSCs from healthy donors. Six patients with spinocerebellar ataxia type 3 and one with multiple system atrophy-cerebellar type were included in this open-label study with intravenous administration of 10 6 cells/kg body weight. The subjects were closely monitored for 1 year for safety (vital signs, complete blood counts, serum biochemical profiles, and urinalysis) and possible efficacy (scale for assessment and rating of ataxia and sensory organization testing scores, metabolite ratios on the brain magnetic resonance spectroscopy, and brain glucose metabolism of 18-fluorodeoxyglucose using positron emission tomography). No adverse events related to the injection of MSCs during the 1-year follow-up were observed. The intravenous administration of allogeneic MSCs seemed well tolerated. Upon study completion, all patients wished to continue treatment with the allogeneic MSCs. We conclude that allogeneic MSCs given by intravenous injection seems to be safe and tolerable in patients with spinocerebellar ataxia type 3, thus supporting advancement of the clinical development of allogeneic MSCs for the treatment of spinocerebellar ataxias (SCAs) in a randomized, double-blind, placebo-controlled phase II trials.
AbstractList Ataxia is one of the most devastating symptoms of many neurodegenerative disorders. As of today, there is not any effective treatment to retard its progression. Mesenchymal stem cells (MSCs) have shown promise in treating neurodegenerative diseases. We hereby report the results of a phase I/IIa clinical study conducted in Taiwan to primarily evaluate the safety, tolerability, and, secondarily, the possible efficacy of intravenous administration of allogeneic adipose tissue-derived MSCs from healthy donors. Six patients with spinocerebellar ataxia type 3 and one with multiple system atrophy-cerebellar type were included in this open-label study with intravenous administration of 10 6 cells/kg body weight. The subjects were closely monitored for 1 year for safety (vital signs, complete blood counts, serum biochemical profiles, and urinalysis) and possible efficacy (scale for assessment and rating of ataxia and sensory organization testing scores, metabolite ratios on the brain magnetic resonance spectroscopy, and brain glucose metabolism of 18-fluorodeoxyglucose using positron emission tomography). No adverse events related to the injection of MSCs during the 1-year follow-up were observed. The intravenous administration of allogeneic MSCs seemed well tolerated. Upon study completion, all patients wished to continue treatment with the allogeneic MSCs. We conclude that allogeneic MSCs given by intravenous injection seems to be safe and tolerable in patients with spinocerebellar ataxia type 3, thus supporting advancement of the clinical development of allogeneic MSCs for the treatment of spinocerebellar ataxias (SCAs) in a randomized, double-blind, placebo-controlled phase II trials.
Ataxia is one of the most devastating symptoms of many neurodegenerative disorders. As of today, there is not any effective treatment to retard its progression. Mesenchymal stem cells (MSCs) have shown promise in treating neurodegenerative diseases. We hereby report the results of a phase I/IIa clinical study conducted in Taiwan to primarily evaluate the safety, tolerability, and, secondarily, the possible efficacy of intravenous administration of allogeneic adipose tissue-derived MSCs from healthy donors. Six patients with spinocerebellar ataxia type 3 and one with multiple system atrophy-cerebellar type were included in this open-label study with intravenous administration of 106 cells/kg body weight. The subjects were closely monitored for 1 year for safety (vital signs, complete blood counts, serum biochemical profiles, and urinalysis) and possible efficacy (scale for assessment and rating of ataxia and sensory organization testing scores, metabolite ratios on the brain magnetic resonance spectroscopy, and brain glucose metabolism of 18-fluorodeoxyglucose using positron emission tomography). No adverse events related to the injection of MSCs during the 1-year follow-up were observed. The intravenous administration of allogeneic MSCs seemed well tolerated. Upon study completion, all patients wished to continue treatment with the allogeneic MSCs. We conclude that allogeneic MSCs given by intravenous injection seems to be safe and tolerable in patients with spinocerebellar ataxia type 3, thus supporting advancement of the clinical development of allogeneic MSCs for the treatment of spinocerebellar ataxias (SCAs) in a randomized, double-blind, placebo-controlled phase II trials.Ataxia is one of the most devastating symptoms of many neurodegenerative disorders. As of today, there is not any effective treatment to retard its progression. Mesenchymal stem cells (MSCs) have shown promise in treating neurodegenerative diseases. We hereby report the results of a phase I/IIa clinical study conducted in Taiwan to primarily evaluate the safety, tolerability, and, secondarily, the possible efficacy of intravenous administration of allogeneic adipose tissue-derived MSCs from healthy donors. Six patients with spinocerebellar ataxia type 3 and one with multiple system atrophy-cerebellar type were included in this open-label study with intravenous administration of 106 cells/kg body weight. The subjects were closely monitored for 1 year for safety (vital signs, complete blood counts, serum biochemical profiles, and urinalysis) and possible efficacy (scale for assessment and rating of ataxia and sensory organization testing scores, metabolite ratios on the brain magnetic resonance spectroscopy, and brain glucose metabolism of 18-fluorodeoxyglucose using positron emission tomography). No adverse events related to the injection of MSCs during the 1-year follow-up were observed. The intravenous administration of allogeneic MSCs seemed well tolerated. Upon study completion, all patients wished to continue treatment with the allogeneic MSCs. We conclude that allogeneic MSCs given by intravenous injection seems to be safe and tolerable in patients with spinocerebellar ataxia type 3, thus supporting advancement of the clinical development of allogeneic MSCs for the treatment of spinocerebellar ataxias (SCAs) in a randomized, double-blind, placebo-controlled phase II trials.
Ataxia is one of the most devastating symptoms of many neurodegenerative disorders. As of today, there is not any effective treatment to retard its progression. Mesenchymal stem cells (MSCs) have shown promise in treating neurodegenerative diseases. We hereby report the results of a phase I/IIa clinical study conducted in Taiwan to primarily evaluate the safety, tolerability, and, secondarily, the possible efficacy of intravenous administration of allogeneic adipose tissue-derived MSCs from healthy donors. Six patients with spinocerebellar ataxia type 3 and one with multiple system atrophy-cerebellar type were included in this open-label study with intravenous administration of 10 6 cells/kg body weight. The subjects were closely monitored for 1 year for safety (vital signs, complete blood counts, serum biochemical profiles, and urinalysis) and possible efficacy (scale for assessment and rating of ataxia and sensory organization testing scores, metabolite ratios on the brain magnetic resonance spectroscopy, and brain glucose metabolism of 18-fluorodeoxyglucose using positron emission tomography). No adverse events related to the injection of MSCs during the 1-year follow-up were observed. The intravenous administration of allogeneic MSCs seemed well tolerated. Upon study completion, all patients wished to continue treatment with the allogeneic MSCs. We conclude that allogeneic MSCs given by intravenous injection seems to be safe and tolerable in patients with spinocerebellar ataxia type 3, thus supporting advancement of the clinical development of allogeneic MSCs for the treatment of spinocerebellar ataxias (SCAs) in a randomized, double-blind, placebo-controlled phase II trials.
Ataxia is one of the most devastating symptoms of many neurodegenerative disorders. As of today, there is not any effective treatment to retard its progression. Mesenchymal stem cells (MSCs) have shown promise in treating neurodegenerative diseases. We hereby report the results of a phase I/IIa clinical study conducted in Taiwan to primarily evaluate the safety, tolerability, and, secondarily, the possible efficacy of intravenous administration of allogeneic adipose tissue-derived MSCs from healthy donors. Six patients with spinocerebellar ataxia type 3 and one with multiple system atrophy-cerebellar type were included in this open-label study with intravenous administration of 106 cells/kg body weight. The subjects were closely monitored for 1 year for safety (vital signs, complete blood counts, serum biochemical profiles, and urinalysis) and possible efficacy (scale for assessment and rating of ataxia and sensory organization testing scores, metabolite ratios on the brain magnetic resonance spectroscopy, and brain glucose metabolism of 18-fluorodeoxyglucose using positron emission tomography). No adverse events related to the injection of MSCs during the 1-year follow-up were observed. The intravenous administration of allogeneic MSCs seemed well tolerated. Upon study completion, all patients wished to continue treatment with the allogeneic MSCs. We conclude that allogeneic MSCs given by intravenous injection seems to be safe and tolerable in patients with spinocerebellar ataxia type 3, thus supporting advancement of the clinical development of allogeneic MSCs for the treatment of spinocerebellar ataxias (SCAs) in a randomized, double-blind, placebo-controlled phase II trials.
Author Wu, Yu-Shan
Chang, Chin-Hao
Soong, Bing-Wen
Wang, Yi-Chen
Ho, Jennifer Hui-Chun
Lirng, Jiing-Feng
Tsai, Yun-An
Lee, Oscar K.
Liu, Ren-Shyan
Yang, Bang-Hung
AuthorAffiliation Department of Nuclear Medicine, Taipei Veterans General Hospital, Taipei, Taiwan
Institute of Clinical Medicine, National Yang-Ming University, Taipei, Taiwan
Department of Radiology, Taipei Veterans General Hospital, Taipei, Taiwan
Department of Medical Research, National Taiwan University Hospital, Taipei, Taiwan
Steminent Biotherapeutics Inc., Taipei, Taiwan
Department of Neurology, Taipei Veterans General Hospital, Taipei, Taiwan
Department of Neurosurgery, Neurological Institute, Taipei Veterans General Hospital, Taipei, Taiwan
Taipei City Hospital, Taipei, Taiwan
Faculty of Biomedical Imaging and Radiological Sciences, National Yang-Ming University, Taipei, Taiwan
Stem Cell Research Center, National Yang-Ming University, Taipei, Taiwan
Department of Neurology, National Yang-Ming University, Taipei, Taiwan
AuthorAffiliation_xml – name: Department of Neurosurgery, Neurological Institute, Taipei Veterans General Hospital, Taipei, Taiwan
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– name: Faculty of Biomedical Imaging and Radiological Sciences, National Yang-Ming University, Taipei, Taiwan
– name: Steminent Biotherapeutics Inc., Taipei, Taiwan
– name: Taipei City Hospital, Taipei, Taiwan
– name: Department of Neurology, Taipei Veterans General Hospital, Taipei, Taiwan
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– name: Department of Neurology, National Yang-Ming University, Taipei, Taiwan
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BackLink https://www.ncbi.nlm.nih.gov/pubmed/28195034$$D View this record in MEDLINE/PubMed
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– notice: 2017 SAGE Publications Inc. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the associated terms available at: https://uk.sagepub.com/en-gb/eur/reusing-open-access-and-sage-choice-content
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Keywords Clinical trials
Gait disorders/ataxia
Allogeneic mesenchymal stem cells (MSCs)
Trinucleotide repeat diseases
Spinocerebellar ataxias (SCAs)
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  text: 20170300
PublicationDecade 2010
PublicationPlace Los Angeles, CA
PublicationPlace_xml – name: Los Angeles, CA
– name: United States
– name: Thousand Oaks
– name: Sage CA: Los Angeles, CA
PublicationTitle Cell transplantation
PublicationTitleAlternate Cell Transplant
PublicationYear 2017
Publisher SAGE Publications
Sage Publications Ltd
SAGE Publishing
Publisher_xml – name: SAGE Publications
– name: Sage Publications Ltd
– name: SAGE Publishing
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Snippet Ataxia is one of the most devastating symptoms of many neurodegenerative disorders. As of today, there is not any effective treatment to retard its...
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SubjectTerms Adipose tissue
Adult
Aged
Ataxia
Atrophy
Body weight
Brain - pathology
Cells, Cultured
Cerebellum
Clinical trials
Double-Blind Method
Female
Glucose metabolism
Humans
Injection
Intravenous administration
Machado-Joseph disease
Magnetic Resonance Spectroscopy
Male
Mesenchymal Stem Cell Transplantation - methods
Mesenchymal stem cells
Metabolites
Middle Aged
Neurodegenerative diseases
Patients
Positron emission tomography
Spinocerebellar ataxia
Spinocerebellar Ataxias - therapy
Stem cells
Transplantation, Homologous - methods
Urinalysis
Young Adult
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Title Treatment of Spinocerebellar Ataxia with Mesenchymal Stem Cells: A Phase I/IIa Clinical Study
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https://www.ncbi.nlm.nih.gov/pubmed/28195034
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Volume 26
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