Stereotactic brain injection of human umbilical cord blood mesenchymal stem cells in patients with Alzheimer's disease dementia: A phase 1 clinical trialopen access
- Authors
- Kim, Hee Jin; Seo, Sang Won; Chang, Jong Wook; Lee, Jung Il; Kim, Chi Hun; Chin, Juhee; Choi, Soo Jin; Kwon, Hunki; Yun, Hyuk Jin; Lee, Jong Min; Kim, Sung Tae; Choe, Yearn Seong; Lee, Kyung-Han; Na, Duk L.
- Issue Date
- Oct-2015
- Publisher
- Elsevier Inc.
- Keywords
- Alzheimer' s disease; Hippocampus; Mesenchymal stem cell; Precuneus; Stereotactic injection
- Citation
- Alzheimer's and Dementia: Translational Research and Clinical Interventions, v.1, no.2, pp.95 - 102
- Indexed
- SCOPUS
- Journal Title
- Alzheimer's and Dementia: Translational Research and Clinical Interventions
- Volume
- 1
- Number
- 2
- Start Page
- 95
- End Page
- 102
- URI
- https://scholarworks.bwise.kr/hanyang/handle/2021.sw.hanyang/156186
- DOI
- 10.1016/j.trci.2015.06.007
- ISSN
- 2352-8737
- Abstract
- Introduction We 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). Methods The 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. Results No 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. Discussion Administration 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.
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