NCT04954534

Brief Summary

This study is to evaluate of Exploratory Efficacy of NEUROSTEM® in Subjects who control group of NEUROSTEM® Phase-I/IIa Clinical Trial

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

June 1, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 8, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

July 12, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

July 14, 2021

Status Verified

July 1, 2021

Enrollment Period

7 months

First QC Date

June 1, 2021

Last Update Submit

July 8, 2021

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

  • Change from the baseline in ADAS-Cog

    The ADAS-Cog is a psychometric instrument that evaluates memory, attention, reasoning, language, orientation, and praxis using an 11-point AD Assessment Scale. It has a minimum score of 0 and a maximum severity score of 70, and a higher score indicates more impairment.

    4weeks,8weeks,12weeks,24 weeks after the first dose

Secondary Outcomes (7)

  • Change in CDR-SOB

    24 weeks after the first dose

  • Change from the baseline in K-MMSE(korean version)

    24 weeks after the first dose

  • Change from the baseline in CGA-NPI

    24 weeks after the first dose

  • Change from the baseline in SIB

    24 weeks after the first dose

  • ADAS-Cog Response Rate

    The ADAS-cog response is defined as no worsening (no change or improvement on ADAS-cog score) of the ADAS-cog score at 24 weeks after the first administration compared to the baseline

  • +2 more secondary outcomes

Study Arms (1)

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

Interventions

human umbilical cord blood derived mesenchymal stem cellsBIOLOGICAL

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 dose

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects who have been treated with placebo in phase 1/2a clinical trial of NEUROSTEM®
  • 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:

  • History of stroke within 3 months prior to study enrollment
  • Severe liver disorder (equivalent to double the normal values of ALT and AST) at Visit 1
  • Severe kidney disorder (serum creatinine ≥1.5mg/dL) at Visit 1
  • Abnormal Laboratory findings at Visit 1
  • Hemoglobin \< 9.5 g/dL for male and \<9.0 g/dL for female
  • Total WBC Count \< 3000/mm3
  • Total Bilirubin \>= 3 mg/dL
  • Suspected active lung disease based on chest X-ray at Visit 1
  • Bleeding disorder (abnormal blood coagulation test result (i.e. platelet count of \< 137,000/mm3, PT ≥ 1.5 INR, or aPTT ≥ 1.5 x control anti-coagulant or anti-platelet, without anticoagulant or anti-platelet therapy)
  • Diagnosis of cancer (of any body system, including brain tumor)
  • Contraindicated for any of the tests performed during the clinical trial period (for example, MRI, CT, PET)
  • Whom the principal investigator considers inappropriate for participation in the study due to any reasons other than those listed above

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Publications (1)

  • 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

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Duk L. Na, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Heejin kim, MD

CONTACT

+82-2-3410-1947evekhj@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 1, 2021

First Posted

July 8, 2021

Study Start

July 12, 2021

Primary Completion

January 31, 2022

Study Completion

June 30, 2022

Last Updated

July 14, 2021

Record last verified: 2021-07

Locations

KR(1)