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J Korean Neurol Assoc. 2009 May;27(2):163-169. Korean. Original Article.
Kim HY , Paek JY , Park HK , Choi MR , Yoon HS , Kim KS , Kim SH .
Department of Neurology, College of Medicine, Hanyang University Hospital, Seoul, Korea.
Bioengineering Institute, CoreStem Inc., Seoul, Korea.
Division of Molecular and Life Sciences, Hanyang University, Ansan, Korea.
Department of Anatomy and Cell Biology, College of Medicine, Hanyang University, Seoul, Korea.

BACKGROUND: This study was performed to investigate the efficacy and safety of intrathecal autologous bone marrowderived mesenchymal stem cells (MSCs) treatment for patients with ALS. METHODS: After a lead-in period for 3 months, 22 patients were treated with MSCs twice at an interval of 1 month. After initial MSCs injection, all patients were followed up for 3 months and their disease course, clinical characteristics were assessed. Disease status of patients were analyzed with ALS functional rating scale-revised (ALSFRS-R) for primary outcome measure, and additional clinical findings after treatment were all collected for secondary outcome measure and safety. Age and disease-duration matched patients with ALS were selected as a control group. RESULTS: During the follow-up period, MSCs treatment yielded a significant lesser change of ALSFRS-R score, compared to control group (1.54 vs 3.56, p<0.01). Moreover, the slop of decline of ALSFRS-R was significantly lower during the follow-up period, compared to the lead-in period in MSCs treatment group (2.68 vs 1.54, p=0.04), whereas the slopes during the two periods were not different in the control group (3.15 vs 3.56, p=0.37). MSCs treatment was well tolerated except for occurrences of transient headache, low back pain, and myalgia. CONCLUSIONS: Our results show that intrathecal MSCs injection can slow disease progression and might be used as a disease modifying modality as an alternative treatment choice in patients with ALS.

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