Open AccessStereotactic brain injection of human umbilical cord blood mesenchymal stem cells in patients with Alzheimer's disease dementia: A phase 1 clinical trial
Author(s) -
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 KyungHan,
Na Duk L.
Publication year - 2015
Publication title -
alzheimer's and dementia: translational research and clinical interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.49
H-Index - 30
ISSN - 2352-8737
DOI - 10.1016/j.trci.2015.06.007
Subject(s) - medicine , umbilical cord , adverse effect , clinical trial , mesenchymal stem cell , dementia , anesthesia , toxicity , surgery , disease , pathology , immunology
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 × 10 6 cells/60 μL and 6.0 × 10 6 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. Clinical Trial Registration ClinicalTrial.gov identifier NCT01297218 and NCT01696591 .