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

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.

CLINICAL TRIAL REGISTRATION:

ClinicalTrial.gov identifier NCT01297218 and NCT01696591.

• Authors: Hee Jin Kim, Sang Won Seo, Jong Wook Chang, Jung Il Lee, Chi Hun Kim, Juhee Chin, Soo Jin Choi, Hunki Kwon, Hyuk Jin Yun, Jong Min Lee, Sung Tae Kim, Yearn Seong Choe, Kyung-Han Lee, Duk L Na
• Journal: Alzheimer's & dementia (New York, N. Y.) (Alzheimers Dement (N Y)) Vol. 1 Issue 2 Pg. 95-102 (Sep 2015) ISSN: 2352-8737 [Electronic] United States
• PMID: 29854930 (Publication Type: Journal Article)