Stereotactic brain injection of human umbilical cord blood mesenchymal stem cells in patients with Alzheimer's disease dementia: A phase 1 clinical trial

Alzheimer's and Dementia: Translational Research and Clinical Interventions - Tập 1 - Trang 95-102 - 2015
Hee Jin Kim1,2, Sang Won Seo1,2,3, Jong Wook Chang4,5, Jung Il Lee2,6, Chi Hun Kim7, Juhee Chin1,2, Soo Jin Choi5, Hunki Kwon8, Hyuk Jin Yun8, Jong Min Lee8, Sung Tae Kim9, Yearn Seong Choe10, Kyung-Han Lee10, Duk L. Na1,2,11
1Department of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, 06351, Korea
2Neuroscience Center, Samsung Medical Center, Seoul, Korea
3Department of Clinical Research Design & Evaluation, SAIHST, Sungkyunkwan University, Seoul, Korea
4Stem Cell & Regenerative Medicine Center, Research Institute for Future Medicine, Samsung Medical Center, Seoul, Korea
5Biomedical Research Institute, MEDIPOST Co., Ltd., Seoul, Korea
6Department of Neurosurgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
7Department of Psychology, Behavioural and Clinical Neuroscience Institute, University of Cambridge, Cambridge, UK
8Department of Biomedical Engineering, Hanyang University, Seoul, Korea
9Department of Radiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
10Department of Nuclear Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
11Department of Health Sciences and Technology, SAIHST, Sungkyunkwan University, Seoul, Korea

Tóm tắt

AbstractIntroductionWe conducted a phase 1 clinical trial in nine patients with mild‐to‐moderate Alzheimer's disease to evaluate the safety and dose‐limiting toxicity of stereotactic brain injection of human umbilical cord blood–derived mesenchymal stem cells (hUCB‐MSCs).MethodsThe low‐ (n = 3) and high‐dose (n = 6) groups received a total of 3.0 × 106 cells/60 μL and 6.0 × 106 cells/60 μL, respectively, into the bilateral hippocampi and right precuneus.ResultsNo patient showed serious adverse events including fever during the 24‐month follow‐up period. During the 12‐week follow‐up period, the most common acute adverse event was wound pain from the surgical procedure (n = 9), followed by headache (n = 4), dizziness (n = 3), and postoperative delirium (n = 3). There was no dose‐limiting toxicity.DiscussionAdministration of hUCB‐MSCs into the hippocampus and precuneus by stereotactic injection was feasible, safe, and well tolerated. Further trials are warranted to test the efficacy.Clinical Trial RegistrationClinicalTrial.gov identifier NCT01297218 and NCT01696591.

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Alzheimer's and Dementia: Translational Research and Clinical Interventions

Tập 1

95-102

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