Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2015 Jul 26;1(2):95-102.
doi: 10.1016/j.trci.2015.06.007. eCollection 2015 Sep.

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

Hee Jin Kim  1   2 , Sang Won Seo  1   2   3 , Jong Wook Chang  4   5 , Jung Il Lee  2   6 , Chi Hun Kim  7 , Juhee Chin  1   2 , Soo Jin Choi  5 , Hunki Kwon  8 , Hyuk Jin Yun  8 , Jong Min Lee  8 , Sung Tae Kim  9 , Yearn Seong Choe  10 , Kyung-Han Lee  10 , Duk L Na  1   2   11
Affiliations

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

Hee Jin Kim et al. Alzheimers Dement (N Y). .

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.

Keywords: Alzheimer's disease; Hippocampus; Mesenchymal stem cell; Precuneus; Stereotactic injection.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
Intraoperative navigation–guided stereotactic administration of hUCB-MSCs. hUCB-MSCs were injected into the right and left hippocampus and right precuneus at four sites (5-mm intervals) along the inserted trajectory while retracting the cannula (A). However, in six of nine patients, the fourth injection was located on the temporal horn of the lateral ventricle, probably due to substantial hippocampal atrophy. In these cases, the omitted doses were injected into the right precuneus, resulting in three injection sites in each hippocampus and six sites in the right precuneus (B). An example of stereotactic administration of hUCB-MSCs into the left hippocampus (C). Each patient received 12 injections for a total of 3.0 × 106 cells/60 μL in the low dose group or 6.0 × 106 cells/60 μL in the high dose group. Abbreviation: hUCB-MSCs, human umbilical cord blood–derived mesenchymal stem cells.
See this image and copyright information in PMC

References

    1. Caplan A.I. Mesenchymal stem cells. J Orthop Res. 1991;9:641–650. - PubMed
    1. Kim J.Y., Kim D.H., Kim J.H., Lee D., Jeon H.B., Kwon S.J. Soluble intracellular adhesion molecule-1 secreted by human umbilical cord blood-derived mesenchymal stem cell reduces amyloid-beta plaques. Cell Death Differ. 2012;19:680–691. - PMC - PubMed
    1. Kim J.Y., Kim D.H., Kim D.S., Kim J.H., Jeong S.Y., Jeon H.B. Galectin-3 secreted by human umbilical cord blood-derived mesenchymal stem cells reduces amyloid-beta 42 neurotoxicity in vitro. FEBS Lett. 2010;584:3601–3608. - PubMed
    1. Lee H.J., Lee J.K., Lee H., Shin J.W., Carter J.E., Sakamoto T. The therapeutic potential of human umbilical cord blood-derived mesenchymal stem cells in Alzheimer's disease. Neurosci Lett. 2010;481:30–35. - PubMed
    1. Venkataramana N.K., Kumar S.K., Balaraju S., Radhakrishnan R.C., Bansal A., Dixit A. Open-labeled study of unilateral autologous bone-marrow-derived mesenchymal stem cell transplantation in Parkinson's disease. Transl Res. 2010;155:62–70. - PubMed

Associated data