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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-19

Study Completion Date

2022-03-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Exploratory Efficacy Study of NEUROSTEM® Versus Placebo in Patients With Alzheimer's Disease

NCT02054208

Alzheimer's Disease

COMPLETED PHASE1/PHASE2

The Safety and The Efficacy Evaluation of NEUROSTEM®-AD in Patients With Alzheimer's Disease

NCT01297218

Dementia of the Alzheimer's Type

COMPLETED PHASE1

Exploratory Efficacy Study of NEUROSTEM® in Subjects Who Control Group of NEUROSTEM®

NCT04954534

Alzheimer's Disease

UNKNOWN NA

The Long-Term Safety and Efficacy Follow-Up Study of Subjects Who Completed the Phase I Clinical Trial of Neurostem®-AD

NCT01696591

Alzheimer Disease Dementia Brain Diseases +6 more

UNKNOWN

Safety and Efficiency of Umbilical Cord-derived Mesenchymal Stem Cells(UC-MSC) in Patients With Alzheimer's Disease

NCT01547689

Alzheimer's Disease

UNKNOWN PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer's Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

human umbilical cord blood derived mesenchymal stem cells

Intervention Type 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

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

Group Type EXPERIMENTAL

human umbilical cord blood derived mesenchymal stem cells

Intervention Type 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

Placebo

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

Group Type PLACEBO_COMPARATOR

Normal saline 2mL

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type BIOLOGICAL

Normal saline 2mL

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

NEUROSTEM®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

50 Years

Maximum Eligible Age

86 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No