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Safety of intrathecal injection of Wharton’s jelly-derived mesenchymal stem cells in amyotrophic lateral sclerosis therapy
Monika Barczewska1, Mariusz Grudniak2, Stanisław Maksymowicz PhD 3
 , Tomasz Siwek1, Tomasz Ołdak2, Katarzyna Jezierska-Woźniak4, Dominika Gładysz2, Wojciech Maksymowicz5
1 Department of Neurology and Neurosurgery, School of Medicine, Collegium Medicum - University of Warmia and Mazury in Olsztyn; University Clinical Hospital in Olsztyn; Instytut Terapii Komórkowych w Olsztynie (Cell Therapies Institute, FamiCord Group), Olsztyn, Poland
2 Polski Bank Komórek Macierzystych (PBKM, FamiCord Group), Warszawa, Poland
3 Department of Psychology, Clinical Logopedics and Social Science in Medicine, Faculty of Health Sciences, Collegium Medicum - University of Warmia and Mazury in Olsztyn; Instytut Terapii Komórkowych w Olsztynie (Cell Therapies Institute, FamiCord Group), Olsztyn, Poland
4 Department of Neurology and Neurosurgery, Laboratory of Regenerative Medicine, School of Medicine, Collegium Medicum-University of Warmia and Mazury in Olsztyn, Olsztyn, Poland
5 Department of Neurology and Neurosurgery, School of Medicine, Collegium Medicum - University of Warmia and Mazury in Olsztyn; University Clinical Hospital in Olsztyn, Olsztyn, Poland
Correspondence Address:
Stanisław Maksymowicz
Department of Psychology, Clinical Logopedics and Social Science in Medicine, Faculty of Health Sciences, Collegium Medicum - University of Warmia and Mazury in Olsztyn; Instytut Terapii Komórkowych w Olsztynie (Cell Therapies Institute, FamiCord Group), Olsztyn
Poland
 Source of Support: This research was supported by Instytut Terapii Komórkowych w Olsztynie (Cell Therapies Institute, FamiCord Group) in Olsztyn (to
MB, SM, and TS), Conflict of Interest: None  | Check |
DOI: 10.4103/1673-5374.243723
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Animal experiments have confirmed that mesenchymal stem cells can inhibit motor neuron apoptosis and inflammatory factor expression and increase neurotrophic factor expression. Therefore, mesenchymal stem cells have been shown to exhibit prospects in the treatment of amyotrophic lateral sclerosis. However, the safety of their clinical application needs to be validated. To investigate the safety of intrathecal injection of Wharton’s jelly-derived mesenchymal stem cells in amyotrophic lateral sclerosis therapy, 43 patients (16 females and 27 males, mean age of 57.3 years) received an average dose of 0.42 × 106 cells/kg through intrathecal administration at the cervical, thoracic or lumbar region depending on the clinical symptoms. There was a 2 month interval between two injections. The adverse events occurring during a 6-month treatment period were evaluated. No adverse events occurred. Headache occurred in one case only after first injection of stem cells. This suggests that intrathecal injection of Wharton’s Jelly-derived mesenchymal stem cells is well tolerated in patients with amyotrophic lateral sclerosis. This study was approved by the Bioethical Committee of School of Medicine, University of Warmia and Mazury in Olsztyn, Poland (approval No. 36/2014 and approval No. 8/2016). This study was registered with the ClinicalTrials.gov (identifier: NCT02881476) on August 29, 2016.
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