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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
human umbilical cord blood derived mesenchymal stem cells
Normal saline 2mL
Sponsored by
Medipost Co Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

50 Years - 86 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

NEUROSTEM® (hUCB-MSCs)- low dose

NEUROSTEM® (hUCB-MSCs) - high dose

Placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Change from the baseline in ADAS-Cog
Alzheimer's Disease assessment Scale-Cognitive Subscale

Secondary Outcome Measures

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

Full Information

First Posted
May 29, 2017
Last Updated
March 13, 2023
Sponsor
Medipost Co Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03172117
Brief Title
Follow-up Study of Safety and Efficacy in Subjects Who Completed NEUROSTEM® Phase-I/IIa Clinical Trial.
Official Title
Follow-up Study of Safety and Efficacy in Subjects Who Completed NEUROSTEM® Phase-I/IIa Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
May 19, 2017 (Actual)
Primary Completion Date
March 18, 2022 (Actual)
Study Completion Date
March 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medipost Co Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NEUROSTEM® (hUCB-MSCs)- low dose
Arm Type
Experimental
Arm Description
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
Arm Title
NEUROSTEM® (hUCB-MSCs) - high dose
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
normal saline 2mL, doses separated by 4 weeks for a total of 3 doses
Intervention Type
Biological
Intervention Name(s)
human umbilical cord blood derived mesenchymal stem cells
Other Intervention Name(s)
NEUROSTEM®
Intervention Description
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
Other
Intervention Name(s)
Normal saline 2mL
Intervention Description
Normal Saline at 4 week intervals via an Ommaya Reservoir, for a total of 3 administrations
Primary Outcome Measure Information:
Title
Change from the baseline in ADAS-Cog
Description
Alzheimer's Disease assessment Scale-Cognitive Subscale
Time Frame
24 month after the first dose
Secondary Outcome Measure Information:
Title
Change from the baseline in S-IADL
Description
Seoul Instrumental Activities of Daily Living
Time Frame
24 month after the first dose
Title
Change from the baseline in K-MMSE
Description
Mini Mental State Exmination Korean version
Time Frame
24 month after the first dose
Title
Change from the baseline in CGA-NPI
Description
Caregiver-administered Neuropsychiatric Inventory
Time Frame
24 month after the first dose
Title
ADAS-Cog Response Rate
Description
the ADAS-cog score at 24 month after the first administration compared to the baseline
Time Frame
24 month after the first dose
Title
Change in CDR-SOB
Description
Clinical Dementia Rating-Sum of Box
Time Frame
24 month after the first dose
Title
Change in CIBIC-plus
Description
The Clinician's Interview Based Impression of Change-plus
Time Frame
24 month after the first dose
Title
Change in Florbetaben-PET
Description
Florbetaben - Pittsburgh Compound B-positron emission tomography
Time Frame
24 month after the first dose
Title
Change in FDG-PET (CMRglc: regional cerebral metabolic rate for glucose)
Description
fluorodeoxyglucose positron emission tomography
Time Frame
24 month after the first dose
Title
Change from baseline in MRI (DTI mapping)
Description
MRI Analysis
Time Frame
24 month after the first dose
Title
Change from the baseline in CSF biomarkers
Description
biomakrer analysis
Time Frame
24 month after the first dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
86 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
34521461
Citation
Kim HJ, Cho KR, Jang H, Lee NK, Jung YH, Kim JP, Lee JI, Chang JW, Park S, Kim ST, Moon SW, Seo SW, Choi SJ, Na DL. Intracerebroventricular injection of human umbilical cord blood mesenchymal stem cells in patients with Alzheimer's disease dementia: a phase I clinical trial. Alzheimers Res Ther. 2021 Sep 14;13(1):154. doi: 10.1186/s13195-021-00897-2.
Results Reference
derived

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

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