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

March 13, 2023 updated by: Medipost Co Ltd.
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
normal saline 2mL, doses separated by 4 weeks for a total of 3 doses
Other: Normal saline 2mL
Normal Saline at 4 week intervals via an Ommaya Reservoir, for a total of 3 administrations
Experimental: NEUROSTEM® (hUCB-MSCs)- low dose
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

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®
Experimental: NEUROSTEM® (hUCB-MSCs) - high dose
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

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®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from the baseline in ADAS-Cog
Time Frame: 24 month after the first dose
Alzheimer's Disease assessment Scale-Cognitive Subscale
24 month after the first dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from the baseline in S-IADL
Time Frame: 24 month after the first dose
Seoul Instrumental Activities of Daily Living
24 month after the first dose
Change from the baseline in K-MMSE
Time Frame: 24 month after the first dose
Mini Mental State Exmination Korean version
24 month after the first dose
Change from the baseline in CGA-NPI
Time Frame: 24 month after the first dose
Caregiver-administered Neuropsychiatric Inventory
24 month after the first dose
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
24 month after the first dose
Change in CDR-SOB
Time Frame: 24 month after the first dose
Clinical Dementia Rating-Sum of Box
24 month after the first dose
Change in CIBIC-plus
Time Frame: 24 month after the first dose
The Clinician's Interview Based Impression of Change-plus
24 month after the first dose
Change in Florbetaben-PET
Time Frame: 24 month after the first dose
Florbetaben - Pittsburgh Compound B-positron emission tomography
24 month after the first dose
Change in FDG-PET (CMRglc: regional cerebral metabolic rate for glucose)
Time Frame: 24 month after the first dose
fluorodeoxyglucose positron emission tomography
24 month after the first dose
Change from baseline in MRI (DTI mapping)
Time Frame: 24 month after the first dose
MRI Analysis
24 month after the first dose
Change from the baseline in CSF biomarkers
Time Frame: 24 month after the first dose
biomakrer analysis
24 month after the first dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medipost Co Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2017

Primary Completion (Actual)

March 18, 2022

Study Completion (Actual)

March 18, 2022

Study Registration Dates

First Submitted

May 29, 2017

First Submitted That Met QC Criteria

May 29, 2017

First Posted (Actual)

June 1, 2017

Study Record Updates

Last Update Posted (Actual)

March 15, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP-CR-010-F/U

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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