NCT03172117

Brief Summary

A long-term follow-up study to obtain safety and efficacy data in subjects who completed phase 1/2a clinical trial of NEUROSTEM® (NCT02054208), comparing NEUROSTEM and placebo groups for up to 36 months after the initial administration in patients suffering from Alzheimer's disease

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2017

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 19, 2017

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 1, 2017

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2022

Completed
Last Updated

March 15, 2023

Status Verified

March 1, 2023

Enrollment Period

4.8 years

First QC Date

May 29, 2017

Last Update Submit

March 13, 2023

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

  • Change from the baseline in ADAS-Cog

    Alzheimer's Disease assessment Scale-Cognitive Subscale

    24 month after the first dose

Secondary Outcomes (10)

  • Change from the baseline in S-IADL

    24 month after the first dose

  • Change from the baseline in K-MMSE

    24 month after the first dose

  • Change from the baseline in CGA-NPI

    24 month after the first dose

  • ADAS-Cog Response Rate

    24 month after the first dose

  • Change in CDR-SOB

    24 month after the first dose

  • +5 more secondary outcomes

Study Arms (3)

NEUROSTEM® (hUCB-MSCs)- low dose

EXPERIMENTAL

human umbilical cord blood derived mesenchymal stem cells Low dose: 1 x 10\^7cells/2mL 3 repeated intraventricular administrations via an Ommaya Reservoir at 4 week intervals

Biological: human umbilical cord blood derived mesenchymal stem cells

NEUROSTEM® (hUCB-MSCs) - high dose

EXPERIMENTAL

human umbilical cord blood derived mesenchymal stem cells High dose: 3 x 10\^7 cells/2mL 3 repeated intraventricular administrations via an Ommaya Reservoir at 4 week intervals

Biological: human umbilical cord blood derived mesenchymal stem cells

Placebo

PLACEBO COMPARATOR

normal saline 2mL, doses separated by 4 weeks for a total of 3 doses

Other: Normal saline 2mL

Interventions

human umbilical cord blood derived mesenchymal stem cellsBIOLOGICAL

Low dose: 1 x 10\^7cells/2mL 3 repeated intraventricular administrations via an Ommaya Reservoir at 4 week intervals High dose: 3 x 10\^7cells/2mL 3 repeated intraventricular administrations via an Ommaya Reservoir at 4 week intervals

Also known as: NEUROSTEM®
NEUROSTEM® (hUCB-MSCs) - high doseNEUROSTEM® (hUCB-MSCs)- low dose
Normal saline 2mLOTHER

Normal Saline at 4 week intervals via an Ommaya Reservoir, for a total of 3 administrations

Placebo

Eligibility Criteria

Age50 Years - 86 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Assessment of safety and exploratory treatment efficacy in subjects who were enrolled and completed phase 1/2a clinical trial of NEUROSTEM®.
  • Subjects who have been treated with either NEUROSTEM® or placebo at least 12 months ago.
  • Subjects who voluntarily decided to participate and signed the consent form after receiving explanations on the clinical trial (in case it is difficult for the participant to sign, the consent of the legal representative)

You may not qualify if:

  • Subjects who were not enrolled in phase 1/2a clinical trial of Neurostem® for assessing safety and exploratory treatment efficacy
  • Other subjects, excluding those listed above, who were deemed unsuitable by the PI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (2)

  • Lee NK, Jang H, Choi Y, Hwangbo S, Lee S, Lee JI, Kim YJ, Chin J, Chang JW, Seo SW, Son HJ, Choi SJ, Na DL, Kim HJ. Mesenchymal Stem Cells With Adjuvant Dexamethasone in Patients With Alzheimer's Disease: A Phase IIa Trial. Dement Neurocogn Disord. 2025 Oct;24(4):272-285. doi: 10.12779/dnd.2025.24.4.272. Epub 2025 Oct 24.

    PMID: 41220869DERIVED

  • Kim HJ, Cho KR, Jang H, Lee NK, Jung YH, Kim JP, Lee JI, Chang JW, Park S, Kim ST, Moon SW, Seo SW, Choi SJ, Na DL. Intracerebroventricular injection of human umbilical cord blood mesenchymal stem cells in patients with Alzheimer's disease dementia: a phase I clinical trial. Alzheimers Res Ther. 2021 Sep 14;13(1):154. doi: 10.1186/s13195-021-00897-2.

    PMID: 34521461DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2017

First Posted

June 1, 2017

Study Start

May 19, 2017

Primary Completion

March 18, 2022

Study Completion

March 18, 2022

Last Updated

March 15, 2023

Record last verified: 2023-03

Locations

KR(1)