Intracerebral transplantation of autologous adipose-derived stem cells for chronic ischemic stroke: A phase I study
Corresponding Author
Tsung-Lang Chiu
Department of Neurosurgery, Bioinnovation Center, Tzu Chi Foundation, Buddhist Tzu Chi General Hospital, Tzu Chi University, Hualien, Taiwan, ROC
Correspondence
Tsung-Lang Chiu, Department of Neurosurgery, Buddhist Tzu Chi General Hospital, Tzu Chi University, 707, Sec. 3, Chung-Yang Rd., Hualien, Taiwan 97002, ROC.
Email: [email protected]
Po-Cheng Lin, Department of Stem Cell Applied Technology, Gwo Xi Stem Cell Applied Technology, Hsinchu 30261, Taiwan.
Email: [email protected]
Search for more papers by this authorRathinasamy Baskaran
Department of Bioinformatics and Medical Engineering, Asia University, Taichung, Taiwan, ROC
Search for more papers by this authorSheng-Tzung Tsai
Department of Neurosurgery, Bioinnovation Center, Tzu Chi Foundation, Buddhist Tzu Chi General Hospital, Tzu Chi University, Hualien, Taiwan, ROC
Search for more papers by this authorChih-Yang Huang
Cardiovascular and Mitochondrial Related Disease Research Center, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Hualien, Taiwan, ROC
Department of Biological Science and Technology, Asia University, Taichung, Taiwan, ROC
Department of Medical Research, China Medical University Hospital, China Medical University, Taichung, Taiwan, ROC
Search for more papers by this authorMing-Hsi Chuang
Department of Technology Management, Chung Hwa University, Hsinchu, Taiwan, ROC
Search for more papers by this authorWan-Sin Syu
Department of Stem Cell Applied Technology, Gwo Xi Stem Cell Applied Technology, Hsinchu, Taiwan, ROC
Search for more papers by this authorHorng-Jyh Harn
Bioinnovation Center, Tzu Chi foundation; Department of Pathology, Buddhist Tzu Chi General Hospital, Tzu Chi University, Hualien, Taiwan, ROC
Search for more papers by this authorYi-Chun Lin
Department of Stem Cell Applied Technology, Gwo Xi Stem Cell Applied Technology, Hsinchu, Taiwan, ROC
Search for more papers by this authorChun-Hung Chen
Department of Stem Cell Applied Technology, Gwo Xi Stem Cell Applied Technology, Hsinchu, Taiwan, ROC
Search for more papers by this authorPi-Chun Huang
Department of Stem Cell Applied Technology, Gwo Xi Stem Cell Applied Technology, Hsinchu, Taiwan, ROC
Search for more papers by this authorYi-Fen Wang
Department of Neurosurgery, Bioinnovation Center, Tzu Chi Foundation, Buddhist Tzu Chi General Hospital, Tzu Chi University, Hualien, Taiwan, ROC
Search for more papers by this authorChi-Hsuan Chuang
Genomics Research Center, Academia Sinica, Taipei, Taiwan, ROC
Search for more papers by this authorCorresponding Author
Po-Cheng Lin
Department of Stem Cell Applied Technology, Gwo Xi Stem Cell Applied Technology, Hsinchu, Taiwan, ROC
Correspondence
Tsung-Lang Chiu, Department of Neurosurgery, Buddhist Tzu Chi General Hospital, Tzu Chi University, 707, Sec. 3, Chung-Yang Rd., Hualien, Taiwan 97002, ROC.
Email: [email protected]
Po-Cheng Lin, Department of Stem Cell Applied Technology, Gwo Xi Stem Cell Applied Technology, Hsinchu 30261, Taiwan.
Email: [email protected]
Search for more papers by this authorShinn-Zong Lin
Department of Neurosurgery, Bioinnovation Center, Tzu Chi Foundation, Buddhist Tzu Chi General Hospital, Tzu Chi University, Hualien, Taiwan, ROC
Search for more papers by this authorCorresponding Author
Tsung-Lang Chiu
Department of Neurosurgery, Bioinnovation Center, Tzu Chi Foundation, Buddhist Tzu Chi General Hospital, Tzu Chi University, Hualien, Taiwan, ROC
Correspondence
Tsung-Lang Chiu, Department of Neurosurgery, Buddhist Tzu Chi General Hospital, Tzu Chi University, 707, Sec. 3, Chung-Yang Rd., Hualien, Taiwan 97002, ROC.
Email: [email protected]
Po-Cheng Lin, Department of Stem Cell Applied Technology, Gwo Xi Stem Cell Applied Technology, Hsinchu 30261, Taiwan.
Email: [email protected]
Search for more papers by this authorRathinasamy Baskaran
Department of Bioinformatics and Medical Engineering, Asia University, Taichung, Taiwan, ROC
Search for more papers by this authorSheng-Tzung Tsai
Department of Neurosurgery, Bioinnovation Center, Tzu Chi Foundation, Buddhist Tzu Chi General Hospital, Tzu Chi University, Hualien, Taiwan, ROC
Search for more papers by this authorChih-Yang Huang
Cardiovascular and Mitochondrial Related Disease Research Center, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Hualien, Taiwan, ROC
Department of Biological Science and Technology, Asia University, Taichung, Taiwan, ROC
Department of Medical Research, China Medical University Hospital, China Medical University, Taichung, Taiwan, ROC
Search for more papers by this authorMing-Hsi Chuang
Department of Technology Management, Chung Hwa University, Hsinchu, Taiwan, ROC
Search for more papers by this authorWan-Sin Syu
Department of Stem Cell Applied Technology, Gwo Xi Stem Cell Applied Technology, Hsinchu, Taiwan, ROC
Search for more papers by this authorHorng-Jyh Harn
Bioinnovation Center, Tzu Chi foundation; Department of Pathology, Buddhist Tzu Chi General Hospital, Tzu Chi University, Hualien, Taiwan, ROC
Search for more papers by this authorYi-Chun Lin
Department of Stem Cell Applied Technology, Gwo Xi Stem Cell Applied Technology, Hsinchu, Taiwan, ROC
Search for more papers by this authorChun-Hung Chen
Department of Stem Cell Applied Technology, Gwo Xi Stem Cell Applied Technology, Hsinchu, Taiwan, ROC
Search for more papers by this authorPi-Chun Huang
Department of Stem Cell Applied Technology, Gwo Xi Stem Cell Applied Technology, Hsinchu, Taiwan, ROC
Search for more papers by this authorYi-Fen Wang
Department of Neurosurgery, Bioinnovation Center, Tzu Chi Foundation, Buddhist Tzu Chi General Hospital, Tzu Chi University, Hualien, Taiwan, ROC
Search for more papers by this authorChi-Hsuan Chuang
Genomics Research Center, Academia Sinica, Taipei, Taiwan, ROC
Search for more papers by this authorCorresponding Author
Po-Cheng Lin
Department of Stem Cell Applied Technology, Gwo Xi Stem Cell Applied Technology, Hsinchu, Taiwan, ROC
Correspondence
Tsung-Lang Chiu, Department of Neurosurgery, Buddhist Tzu Chi General Hospital, Tzu Chi University, 707, Sec. 3, Chung-Yang Rd., Hualien, Taiwan 97002, ROC.
Email: [email protected]
Po-Cheng Lin, Department of Stem Cell Applied Technology, Gwo Xi Stem Cell Applied Technology, Hsinchu 30261, Taiwan.
Email: [email protected]
Search for more papers by this authorShinn-Zong Lin
Department of Neurosurgery, Bioinnovation Center, Tzu Chi Foundation, Buddhist Tzu Chi General Hospital, Tzu Chi University, Hualien, Taiwan, ROC
Search for more papers by this authorAbstract
Current therapy does not provide significant benefits for patients with chronic stroke. Pre-clinical studies suggested that autologous adipose-derived stem cells have benefits for the treatment of chronic stroke. This Phase I open-label study was conducted to demonstrate the safety and efficacy of autologous adipose-derived stem cells (GXNPC1) in chronic stroke. Three patients with chronic stroke were treated with stereotactic implantation of autologous adipose-derived stem cells (1 × 108 cells). The primary endpoints of safety evaluation included adverse events, over a 6 months post-implantation period. The secondary endpoints included improvements in neurological functions. Evolutional change of brain parenchyma was also followed with magnetic resonance imaging (MRI). All three participants improved significantly at 6 months follow-up. The extent of improvement from pre-treatment was: National Institutes of Health Stroke Scale improved 5-15 points, Barthel Index: 25–50 points, Berg balance scale 0–21 points and Fugl-Meyer modified sensation 3–28 points. All three patients had signal change along the implantation tract on MRI one month after surgery. There is no related safety issue through 6 months observation. Clinical measures of neurological symptoms of these patients with chronic stroke improved at 6 months without adverse effects after implantation of autologous adipose-derived stem cells (GXNPC1), which might be correlated with post-implantation changes on brain MRI.
Clinical Trial Registration-URL: https://clinicaltrials.gov/ct2/show/NCT02813512?term=ADSC&cond=Stroke&cntry=TW&draw=2&rank=1 Unique identifier: NCT02813512.
CONFLICT OF INTEREST
The authors declare that they have no conflicts of interest related to the content of this article.
Open Research
DATA AVAILABILITY STATEMENT
The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.
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