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| Name | Class |
|---|---|
| Medipost Co Ltd. | INDUSTRY |
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This study is to evaluate of Exploratory Efficacy of NEUROSTEM® in Subjects who control group of NEUROSTEM® Phase-I/IIa Clinical Trial
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NEUROSTEM (hUCB-MSCs) - high dose | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| human umbilical cord blood derived mesenchymal stem cells | Biological | High dose: 3 x 10^7cells/2mL 3 repeated intraventricular administrations via an Ommaya Reservoir at 4-week intervals |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4weeks,8weeks,12weeks,24 weeks after the first dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 weeks after the first dose |
| Change from the baseline in K-MMSE(korean version) |
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Inclusion Criteria:
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
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Heejin kim, MD | Contact | +82-2-3410-1947 | evekhj@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Duk L. Na, MD, PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 135-710 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41220869 | Derived | Lee NK, Jang H, Choi Y, Hwangbo S, Lee S, Lee JI, Kim YJ, Chin J, Chang JW, Seo SW, Son HJ, Choi SJ, Na DL, Kim HJ. Mesenchymal Stem Cells With Adjuvant Dexamethasone in Patients With Alzheimer's Disease: A Phase IIa Trial. Dement Neurocogn Disord. 2025 Oct;24(4):272-285. doi: 10.12779/dnd.2025.24.4.272. Epub 2025 Oct 24. |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
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 |
| 24 weeks after the first dose |
| 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. | 24 weeks after the first dose |
| 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) | 24 weeks after the first dose |
| ADAS-Cog Response Rate | Alzheimer's Disease assessment Scale-Cognitive Subscale | 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 |
| 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). | 24 weeks after the first dose |
| Change from the baseline in CSF biomarkers | biomakrers analysis (Amyloid beta 42, Phosphorylated tau, Total tau, RBC, WBC, Protein, Glucose) | 24 weeks after the first dose |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |