Volume 16, Issue 1 pp. 3-13
RESEARCH ARTICLE
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Intracerebral transplantation of autologous adipose-derived stem cells for chronic ischemic stroke: A phase I study

Tsung-Lang Chiu

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]

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Rathinasamy Baskaran

Rathinasamy Baskaran

Department of Bioinformatics and Medical Engineering, Asia University, Taichung, Taiwan, ROC

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Sheng-Tzung Tsai

Sheng-Tzung Tsai

Department of Neurosurgery, Bioinnovation Center, Tzu Chi Foundation, Buddhist Tzu Chi General Hospital, Tzu Chi University, Hualien, Taiwan, ROC

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Chih-Yang Huang

Chih-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

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Ming-Hsi Chuang

Ming-Hsi Chuang

Department of Technology Management, Chung Hwa University, Hsinchu, Taiwan, ROC

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Wan-Sin Syu

Wan-Sin Syu

Department of Stem Cell Applied Technology, Gwo Xi Stem Cell Applied Technology, Hsinchu, Taiwan, ROC

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Horng-Jyh Harn

Horng-Jyh Harn

Bioinnovation Center, Tzu Chi foundation; Department of Pathology, Buddhist Tzu Chi General Hospital, Tzu Chi University, Hualien, Taiwan, ROC

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Yi-Chun Lin

Yi-Chun Lin

Department of Stem Cell Applied Technology, Gwo Xi Stem Cell Applied Technology, Hsinchu, Taiwan, ROC

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Chun-Hung Chen

Chun-Hung Chen

Department of Stem Cell Applied Technology, Gwo Xi Stem Cell Applied Technology, Hsinchu, Taiwan, ROC

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Pi-Chun Huang

Pi-Chun Huang

Department of Stem Cell Applied Technology, Gwo Xi Stem Cell Applied Technology, Hsinchu, Taiwan, ROC

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Yi-Fen Wang

Yi-Fen Wang

Department of Neurosurgery, Bioinnovation Center, Tzu Chi Foundation, Buddhist Tzu Chi General Hospital, Tzu Chi University, Hualien, Taiwan, ROC

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Chi-Hsuan Chuang

Chi-Hsuan Chuang

Genomics Research Center, Academia Sinica, Taipei, Taiwan, ROC

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Po-Cheng Lin

Corresponding 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]

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Shinn-Zong Lin

Shinn-Zong Lin

Department of Neurosurgery, Bioinnovation Center, Tzu Chi Foundation, Buddhist Tzu Chi General Hospital, Tzu Chi University, Hualien, Taiwan, ROC

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First published: 13 October 2021
Citations: 20

Abstract

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.

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.

The full text of this article hosted at iucr.org is unavailable due to technical difficulties.