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

Primary Purpose

Alzheimer's Disease

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
human umbilical cord blood derived mesenchymal stem cells
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subjects who have been treated with placebo in phase 1/2a clinical trial of NEUROSTEM®
  2. 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:

  1. History of stroke within 3 months prior to study enrollment
  2. Severe liver disorder (equivalent to double the normal values of ALT and AST) at Visit 1
  3. Severe kidney disorder (serum creatinine ≥1.5mg/dL) at Visit 1

  4. Abnormal Laboratory findings at Visit 1

    • Hemoglobin < 9.5 g/dL for male and <9.0 g/dL for female
    • Total WBC Count < 3000/mm3
    • Total Bilirubin >= 3 mg/dL
  5. Suspected active lung disease based on chest X-ray at Visit 1
  6. Bleeding disorder (abnormal blood coagulation test result (i.e. platelet count of < 137,000/mm3, PT ≥ 1.5 INR, or aPTT ≥ 1.5 x control anti-coagulant or anti-platelet, without anticoagulant or anti-platelet therapy)
  7. Diagnosis of cancer (of any body system, including brain tumor)
  8. Contraindicated for any of the tests performed during the clinical trial period (for example, MRI, CT, PET)
  9. Whom the principal investigator considers inappropriate for participation in the study due to any reasons other than those listed above

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NEUROSTEM (hUCB-MSCs) - high dose

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

Outcomes

Primary Outcome Measures

Change from the baseline in ADAS-Cog
The ADAS-Cog is a psychometric instrument that evaluates memory, attention, reasoning, language, orientation, and praxis using an 11-point AD Assessment Scale. It has a minimum score of 0 and a maximum severity score of 70, and a higher score indicates more impairment.

Secondary Outcome Measures

Change in CDR-SOB
The CDR-SOB(Clinical Dementia Rating, Sum of Boxes) is a global rating of dementia severity based on the clinician's interpretation of the history and examination. The range of this instrument is 0 to 18 with higher numbers indicating greater impairment.
Change from the baseline in K-MMSE(korean version)
The MMSE(Mini-Mental State Examination) is a brief, practical test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language) and results in a total possible score from 0 to 30, with higher scores indicating better function
Change from the baseline in CGA-NPI
Caregiver-administered Neuropsychiatric Inventory, Measure abnormal behavior. The score range is 0-144. A higher score means severe abnormal behavior.
Change from the baseline in SIB
The Severe Impairment Battery (SIB) is an assessment of cognitive dysfunction across nine domains such as memory, language, and orientation. The score ranges from 0 (worst) to 100 (best)
ADAS-Cog Response Rate
Alzheimer's Disease assessment Scale-Cognitive Subscale
Change in CIBIC-plus
The Clinician's Interview-Based Impression of Change-plus(CIBIC-plus) is a rating scale derived from an interview with the patient and caregiver with an independent rater designed to measure several domains of patient function, such as mental/cognitive state, behavior, and activities of daily living. The scores range from 1 (marked improvement) to 7 (marked worsening).
Change from the baseline in CSF biomarkers
biomakrers analysis (Amyloid beta 42, Phosphorylated tau, Total tau, RBC, WBC, Protein, Glucose)

Full Information

First Posted
June 1, 2021
Last Updated
July 8, 2021
Sponsor
Samsung Medical Center
Collaborators
Medipost Co Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04954534
Brief Title
Exploratory Efficacy Study of NEUROSTEM® in Subjects Who Control Group of NEUROSTEM®
Official Title
Exploratory Efficacy Study of NEUROSTEM® in Subjects Who Control Group of NEUROSTEM® Phase-I/IIa Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 12, 2021 (Anticipated)
Primary Completion Date
January 31, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
Collaborators
Medipost Co Ltd.

4. Oversight

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

5. Study Description

Brief Summary
This study is to evaluate of Exploratory Efficacy of NEUROSTEM® in Subjects who control group of NEUROSTEM® Phase-I/IIa Clinical Trial

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
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Anticipated)

8. Arms, Groups, and Interventions

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
Intervention Type
Biological
Intervention Name(s)
human umbilical cord blood derived mesenchymal stem cells
Other Intervention Name(s)
NEUROSTEM
Intervention Description
High dose: 3 x 10^7cells/2mL 3 repeated intraventricular administrations via an Ommaya Reservoir at 4-week intervals
Primary Outcome Measure Information:
Title
Change from the baseline in ADAS-Cog
Description
The ADAS-Cog is a psychometric instrument that evaluates memory, attention, reasoning, language, orientation, and praxis using an 11-point AD Assessment Scale. It has a minimum score of 0 and a maximum severity score of 70, and a higher score indicates more impairment.
Time Frame
4weeks,8weeks,12weeks,24 weeks after the first dose
Secondary Outcome Measure Information:
Title
Change in CDR-SOB
Description
The CDR-SOB(Clinical Dementia Rating, Sum of Boxes) is a global rating of dementia severity based on the clinician's interpretation of the history and examination. The range of this instrument is 0 to 18 with higher numbers indicating greater impairment.
Time Frame
24 weeks after the first dose
Title
Change from the baseline in K-MMSE(korean version)
Description
The MMSE(Mini-Mental State Examination) is a brief, practical test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language) and results in a total possible score from 0 to 30, with higher scores indicating better function
Time Frame
24 weeks after the first dose
Title
Change from the baseline in CGA-NPI
Description
Caregiver-administered Neuropsychiatric Inventory, Measure abnormal behavior. The score range is 0-144. A higher score means severe abnormal behavior.
Time Frame
24 weeks after the first dose
Title
Change from the baseline in SIB
Description
The Severe Impairment Battery (SIB) is an assessment of cognitive dysfunction across nine domains such as memory, language, and orientation. The score ranges from 0 (worst) to 100 (best)
Time Frame
24 weeks after the first dose
Title
ADAS-Cog Response Rate
Description
Alzheimer's Disease assessment Scale-Cognitive Subscale
Time Frame
The ADAS-cog response is defined as no worsening (no change or improvement on ADAS-cog score) of the ADAS-cog score at 24 weeks after the first administration compared to the baseline
Title
Change in CIBIC-plus
Description
The Clinician's Interview-Based Impression of Change-plus(CIBIC-plus) is a rating scale derived from an interview with the patient and caregiver with an independent rater designed to measure several domains of patient function, such as mental/cognitive state, behavior, and activities of daily living. The scores range from 1 (marked improvement) to 7 (marked worsening).
Time Frame
24 weeks after the first dose
Title
Change from the baseline in CSF biomarkers
Description
biomakrers analysis (Amyloid beta 42, Phosphorylated tau, Total tau, RBC, WBC, Protein, Glucose)
Time Frame
24 weeks after the first dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects who have been treated with placebo in phase 1/2a clinical trial of NEUROSTEM® 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: History of stroke within 3 months prior to study enrollment Severe liver disorder (equivalent to double the normal values of ALT and AST) at Visit 1 Severe kidney disorder (serum creatinine ≥1.5mg/dL) at Visit 1 Abnormal Laboratory findings at Visit 1 Hemoglobin < 9.5 g/dL for male and <9.0 g/dL for female Total WBC Count < 3000/mm3 Total Bilirubin >= 3 mg/dL Suspected active lung disease based on chest X-ray at Visit 1 Bleeding disorder (abnormal blood coagulation test result (i.e. platelet count of < 137,000/mm3, PT ≥ 1.5 INR, or aPTT ≥ 1.5 x control anti-coagulant or anti-platelet, without anticoagulant or anti-platelet therapy) Diagnosis of cancer (of any body system, including brain tumor) Contraindicated for any of the tests performed during the clinical trial period (for example, MRI, CT, PET) Whom the principal investigator considers inappropriate for participation in the study due to any reasons other than those listed above
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heejin kim, MD
Phone
+82-2-3410-1947
Email
evekhj@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duk L. Na, MD, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of

12. IPD Sharing Statement

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

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