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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
The subjects will be followed up at 12-month, 24-month, and 36-month (phone call) after the initial administration of NEUROSTEM®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NEUROSTEM® (hUCB-MSCs)- low dose | Experimental | 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 |
|
| 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 |
|
| Placebo | Placebo Comparator | normal saline 2mL, doses separated by 4 weeks for a total of 3 doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| human umbilical cord blood derived mesenchymal stem cells | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from the baseline in ADAS-Cog | Alzheimer's Disease assessment Scale-Cognitive Subscale | 24 month after the first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Change from the baseline in S-IADL | Seoul Instrumental Activities of Daily Living | 24 month after the first dose |
| Change from the baseline in K-MMSE | Mini Mental State Exmination Korean version |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 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. | |
| 34521461 |
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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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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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|
|
| Normal saline 2mL | Other | Normal Saline at 4 week intervals via an Ommaya Reservoir, for a total of 3 administrations |
|
| 24 month after the first dose |
| Change from the baseline in CGA-NPI | Caregiver-administered Neuropsychiatric Inventory | 24 month after the first dose |
| ADAS-Cog Response Rate | the ADAS-cog score at 24 month after the first administration compared to the baseline | 24 month after the first dose |
| Change in CDR-SOB | Clinical Dementia Rating-Sum of Box | 24 month after the first dose |
| Change in CIBIC-plus | The Clinician's Interview Based Impression of Change-plus | 24 month after the first dose |
| Change in Florbetaben-PET | Florbetaben - Pittsburgh Compound B-positron emission tomography | 24 month after the first dose |
| Change in FDG-PET (CMRglc: regional cerebral metabolic rate for glucose) | fluorodeoxyglucose positron emission tomography | 24 month after the first dose |
| Change from baseline in MRI (DTI mapping) | MRI Analysis | 24 month after the first dose |
| Change from the baseline in CSF biomarkers | biomakrer analysis | 24 month after the first dose |
| 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. |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |