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Completed

NCT Number: NCT03172117

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

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

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year–86 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Samsung Medical Center

Seoul, South Korea

About this study

The subjects will be followed up at 12-month, 24-month, and 36-month (phone call) after the initial administration of NEUROSTEM®.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

human umbilical cord blood derived mesenchymal stem cells

Biological

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

Other names: NEUROSTEM®

Normal saline 2mL

Other

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

Primary outcomes

  1. Change from the baseline in ADAS-Cog

    Time frame: 24 month after the first dose

    Alzheimer's Disease assessment Scale-Cognitive Subscale

Secondary outcomes

  1. Change from the baseline in S-IADL

    Time frame: 24 month after the first dose

    Seoul Instrumental Activities of Daily Living

  2. Change from the baseline in K-MMSE

    Time frame: 24 month after the first dose

    Mini Mental State Exmination Korean version

  3. Change from the baseline in CGA-NPI

    Time frame: 24 month after the first dose

    Caregiver-administered Neuropsychiatric Inventory

  4. ADAS-Cog Response Rate

    Time frame: 24 month after the first dose

    the ADAS-cog score at 24 month after the first administration compared to the baseline

  5. Change in CDR-SOB

    Time frame: 24 month after the first dose

    Clinical Dementia Rating-Sum of Box

  6. Change in CIBIC-plus

    Time frame: 24 month after the first dose

    The Clinician's Interview Based Impression of Change-plus

  7. Change in Florbetaben-PET

    Time frame: 24 month after the first dose

    Florbetaben - Pittsburgh Compound B-positron emission tomography

  8. Change in FDG-PET (CMRglc: regional cerebral metabolic rate for glucose)

    Time frame: 24 month after the first dose

    fluorodeoxyglucose positron emission tomography

  9. Change from baseline in MRI (DTI mapping)

    Time frame: 24 month after the first dose

    MRI Analysis

  10. Change from the baseline in CSF biomarkers

    Time frame: 24 month after the first dose

    biomakrer analysis

Sponsors and collaborators

Lead sponsor

Medipost Co Ltd.

Industry

Registry information

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jun 1, 2017
Registry last updated
Mar 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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