Evidence map›Paper›PMID 34521461›Full record

ArticleAlzheimer's research & therapy2021

Intracerebroventricular injection of human umbilical cord blood mesenchymal stem cells in patients with Alzheimer's disease dementia: a phase I clinical trial.

Hee Jin Kim, Kyung Rae Cho, Hyemin Jang, Na Kyung Lee, Young Hee Jung, Jun Pyo Kim, Jung Il Lee, Jong Wook Chang, Seongbeom Park, Sung Tae Kim and 4 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase I
In one paragraph

Article in Alzheimer's research & therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 99 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
99citing papers in PubMed, 5 pooled it
14.5field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02054208 phase1 / phase2completednot on this map

A Double-blind, Single-center, Phase 1/2a Clinical Trial to Evaluate the Safety and Exploratory Efficacy of Intraventricular Administrations of NEUROSTEM® Versus Placebo Via an Ommaya Reservoir in Patients With Alzheimer's Disease

TypeinterventionalSponsorMedipost Co Ltd.Ran2014 to 2019Enrolled46ConditionsAlzheimer's DiseaseArmshuman umbilical cord blood derived mesenchymal stem cells, Normal saline 2mL
NCT03172117 phase1 / phase2completednot on this map

Follow-up Study of Safety and Efficacy in Subjects Who Completed NEUROSTEM® Phase-I/IIa Clinical Trial.

TypeinterventionalSponsorMedipost Co Ltd.Ran2017 to 2022Enrolled36ConditionsAlzheimer's DiseaseArmshuman umbilical cord blood derived mesenchymal stem cells, Normal saline 2mL
3 · Its place in the literature

Who cites it

99 citing papers in PubMed, 5 syntheses or guidelines pooled it, 154 citations in OpenAlex.

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  20. Stem cells therapy molecular tracking - the special focus on nuclear medicine.Reports of practical oncology and radiotherapy : journal of Greatpoland Cancer Center in Poznan and Polish Society of Radiation Oncology · 2026
    Review

39 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 6 institutions in 2 countries.

Hee Jin KimDepartments of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine, 80 Ilwon-ro, Gangnam-gu, Seoul, 135-710, Republic of Korea.
Kyung Rae ChoDepartment of Neurosurgery, Konkuk University School of Medicine, Seoul, Republic of Korea.
Hyemin JangDepartments of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine, 80 Ilwon-ro, Gangnam-gu, Seoul, 135-710, Republic of Korea.
Na Kyung LeeAlzheimer's Disease Convergence Research Center, Samsung Medical Center, Seoul, Republic of Korea.
Young Hee JungDepartment of Neurology, Myongji Hospital, Hanyang University, Goyang, Republic of Korea.
Jun Pyo KimCenter for Neuroimaging, Radiology and Imaging Sciences, Indiana University School of Medicine, Indianapolis, IN, USA.
Jung Il LeeNeuroscience Center, Samsung Medical Center, Seoul, Republic of Korea.
Jong Wook ChangStem Cell & Regenerative Medicine Institute, Samsung Medical Center, Seoul, Republic of Korea.
Seongbeom ParkDepartments of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine, 80 Ilwon-ro, Gangnam-gu, Seoul, 135-710, Republic of Korea.
Sung Tae KimDepartment of Radiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Seung Whan MoonDepartment of Nuclear Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Sang Won SeoDepartments of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine, 80 Ilwon-ro, Gangnam-gu, Seoul, 135-710, Republic of Korea.
Soo Jin ChoiBiomedical Research Institute, R&D Center, MEDIPOST Co., Ltd., Seongnam, Republic of Korea.
Duk L NaDepartments of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine, 80 Ilwon-ro, Gangnam-gu, Seoul, 135-710, Republic of Korea. dukna@naver.com.
Sungkyunkwan University · KRSamsung Medical Center · KRHanyang University · KRIndiana University – Purdue University Indianapolis · USKonkuk University · KRMedipost (South Korea) · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundsAlzheimer's disease is the most common cause of dementia, and currently, there is no disease-modifying treatment. Favorable functional outcomes and reduction of amyloid levels were observed following transplantation of mesenchymal stem cells (MSCs) in animal studies.

objectivesWe conducted a phase I clinical trial in nine patients with mild-to-moderate Alzheimer's disease dementia to evaluate the safety and dose-limiting toxicity of three repeated intracerebroventricular injections of human umbilical cord blood-derived MSCs (hUCB-MSCs).

methodsWe recruited nine mild-to-moderate Alzheimer's disease dementia patients from Samsung Medical Center, Seoul, Republic of Korea. Four weeks prior to MSC administration, the Ommaya reservoir was implanted into the right lateral ventricle of the patients. Three patients received a low dose (1.0 × 10

resultsAfter hUCB-MSC injection, the most common adverse event was fever (n = 9) followed by headache (n = 7), nausea (n = 5), and vomiting (n = 4), which all subsided within 36 h. There were three serious adverse events in two participants that were considered to have arisen from the investigational product. Fever in a low dose participant and nausea with vomiting in another low dose participant each required extended hospitalization by a day. There were no dose-limiting toxicities. Five participants completed the 36-month extended observation study, and no further serious adverse events were observed.

conclusionsThree repeated administrations of hUCB-MSCs into the lateral ventricle via an Ommaya reservoir were feasible, relatively and sufficiently safe, and well-tolerated. Currently, we are undergoing an extended follow-up study for those who participated in a phase IIa trial where upon completion, we hope to gain a deeper understanding of the clinical efficacy of MSC AD therapy.

trial registrationClinicalTrials.gov NCT02054208. Registered on 4 February 2014. ClinicalTrials.gov NCT03172117. Registered on 1 June 2017.

Indexed as

Alzheimer DiseaseMesenchymal Stem CellsMesenchymal Stem Cell TransplantationAnimalsFetal BloodFollow-Up StudiesHumansAlzheimer’s diseaseIntracerebroventricular injectionMesenchymal stem cellPhase I/IIa

Identifiers

PMID34521461
PMCPMC8439008
OpenAlexW3201185476

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.