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

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Medipost Co Ltd.
Sponsor:
Information provided by (Responsible Party):
Medipost Co Ltd.
ClinicalTrials.gov Identifier:
NCT03172117
First received: May 29, 2017
Last updated: NA
Last verified: May 2017
History: No changes posted
  Purpose
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

Condition Intervention Phase
Alzheimer's Disease Biological: human umbilical cord blood derived mesenchymal stem cells Other: Normal saline 2mL Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Follow-up Study of Safety and Efficacy in Subjects Who Completed NEUROSTEM® Phase-I/IIa Clinical Trial.

Resource links provided by NLM:


Further study details as provided by Medipost Co Ltd.:

Primary Outcome Measures:
  • Change from the baseline in ADAS-Cog [ Time Frame: 24 month after the first dose ]
    Alzheimer's Disease assessment Scale-Cognitive Subscale


Secondary Outcome Measures:
  • Change from the baseline in S-IADL [ Time Frame: 24 month after the first dose ]
    Seoul Instrumental Activities of Daily Living

  • Change from the baseline in K-MMSE [ Time Frame: 24 month after the first dose ]
    Mini Mental State Exmination Korean version

  • Change from the baseline in CGA-NPI [ Time Frame: 24 month after the first dose ]
    Caregiver-administered Neuropsychiatric Inventory

  • 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

  • Change in CDR-SOB [ Time Frame: 24 month after the first dose ]
    Clinical Dementia Rating-Sum of Box

  • Change in CIBIC-plus [ Time Frame: 24 month after the first dose ]
    The Clinician's Interview Based Impression of Change-plus

  • Change in Florbetaben-PET [ Time Frame: 24 month after the first dose ]
    Florbetaben - Pittsburgh Compound B-positron emission tomography

  • Change in FDG-PET (CMRglc: regional cerebral metabolic rate for glucose) [ Time Frame: 24 month after the first dose ]
    fluorodeoxyglucose positron emission tomography

  • Change from baseline in MRI (DTI mapping) [ Time Frame: 24 month after the first dose ]
    MRI Analysis

  • Change from the baseline in CSF biomarkers [ Time Frame: 24 month after the first dose ]
    biomakrer analysis


Estimated Enrollment: 45
Actual Study Start Date: May 19, 2017
Estimated Study Completion Date: December 31, 2021
Estimated Primary Completion Date: December 31, 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: NEUROSTEM®
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

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

Ages Eligible for Study:   50 Years to 86 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03172117

Contacts
Contact: Sujin Choi, MD +82-2-3465-6770 sjchoi@medi-post.co.kr

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Heejin Choi, MD    +82-2-3410-1947    evekhj@gmail.com   
Principal Investigator: Duk L Na, MD         
Sponsors and Collaborators
Medipost Co Ltd.
  More Information

Responsible Party: Medipost Co Ltd.
ClinicalTrials.gov Identifier: NCT03172117     History of Changes
Other Study ID Numbers: MP-CR-010-F/U
Study First Received: May 29, 2017
Last Updated: May 29, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 19, 2017