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

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ClinicalTrials.gov Identifier: NCT04954534
Recruitment Status : Not yet recruiting
First Posted : July 8, 2021
Last Update Posted : July 14, 2021
Sponsor:
Collaborator:
Medipost Co Ltd.
Information provided by (Responsible Party):
Duk Lyul Na, Samsung Medical Center

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

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Biological: human umbilical cord blood derived mesenchymal stem cells Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exploratory Efficacy Study of NEUROSTEM® in Subjects Who Control Group of NEUROSTEM® Phase-I/IIa Clinical Trial
Estimated Study Start Date : July 12, 2021
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
High dose: 3 x 10^7cells/2mL 3 repeated intraventricular administrations via an Ommaya Reservoir at 4-week intervals
Other Name: NEUROSTEM




Primary Outcome Measures :
  1. Change from the baseline in ADAS-Cog [ Time Frame: 4weeks,8weeks,12weeks,24 weeks after the first dose ]
    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 :
  1. Change in CDR-SOB [ Time Frame: 24 weeks after the first dose ]
    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.

  2. Change from the baseline in K-MMSE(korean version) [ Time Frame: 24 weeks after the first dose ]
    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

  3. Change from the baseline in CGA-NPI [ Time Frame: 24 weeks after the first dose ]
    Caregiver-administered Neuropsychiatric Inventory, Measure abnormal behavior. The score range is 0-144. A higher score means severe abnormal behavior.

  4. Change from the baseline in SIB [ Time Frame: 24 weeks after the first dose ]
    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)

  5. ADAS-Cog Response Rate [ 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 ]
    Alzheimer's Disease assessment Scale-Cognitive Subscale

  6. Change in CIBIC-plus [ Time Frame: 24 weeks after the first dose ]
    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).

  7. Change from the baseline in CSF biomarkers [ Time Frame: 24 weeks after the first dose ]
    biomakrers analysis (Amyloid beta 42, Phosphorylated tau, Total tau, RBC, WBC, Protein, Glucose)



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04954534


Contacts
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Contact: Heejin kim, MD +82-2-3410-1947 evekhj@gmail.com

Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Medipost Co Ltd.
Investigators
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Principal Investigator: Duk L. Na, MD, PhD Samsung Medical Center
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Responsible Party: Duk Lyul Na, Principal Investigator, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT04954534    
Other Study ID Numbers: SARC-CR-01
First Posted: July 8, 2021    Key Record Dates
Last Update Posted: July 14, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders