Alzheimer's DiseaseNCT04954534
Exploratory Efficacy Study of NEUROSTEM® in Subjects Who Control Group of NEUROSTEM®
A study testing human umbilical cord blood derived mesenchymal stem cells in people with Alzheimer's Disease, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This study is to evaluate of Exploratory Efficacy of NEUROSTEM® in Subjects who control group of NEUROSTEM® Phase-I/IIa Clinical Trial Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- human umbilical cord blood derived mesenchymal stem cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Jul 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploratory Efficacy Study of NEUROSTEM® in Subjects Who Control Group of NEUROSTEM® Phase-I/IIa Clinical Trial
This study is to evaluate of Exploratory Efficacy of NEUROSTEM® in Subjects who control group of NEUROSTEM® Phase-I/IIa Clinical Trial
- Conditions
- Alzheimer's Disease
- Being tested
- human umbilical cord blood derived mesenchymal stem cells
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human umbilical cord blood derived mesenchymal stem cellsBiological
Also called NEUROSTEM
High dose: 3 x 10^7cells/2mL 3 repeated intraventricular administrations via an Ommaya Reservoir at 4-week intervals
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: human umbilical cord blood derived mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4weeks,8weeks,12weeks,24 weeks after the first dose
Secondary outcomes (7)
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.
Measured: 24 weeks after the first dose
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
Measured: 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.
Measured: 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)
Measured: 24 weeks after the first dose
ADAS-Cog Response Rate
Alzheimer's Disease assessment Scale-Cognitive Subscale
Measured: 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).
Measured: 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)
Measured: 24 weeks after the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start12 Jul 2021 (estimated)
- Primary completion31 Jan 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Medipost Co Ltd.
- Responsible party
- Principal investigator, Duk Lyul Na, Samsung Medical Center
- Investigators
- Duk L. Na, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04954534
- Sponsor's protocol ID
- SARC-CR-01
- Status last verified
- Jul 2021
- First submitted
- 1 Jun 2021
- Last updated
- 14 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41220869
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Efficacy Study of NEUROSTEM® in Subjects Who Control Group of NEUROSTEM® Phase-I/IIa Clinical Trial
- ClinicalTrials.gov ID
- NCT04954534
- Acronym / sponsor ID
- SARC-CR-01
- Conditions
- Alzheimer's Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Medipost Co Ltd.
- Study start
- 12 Jul 2021 (estimated)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 8 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to evaluate of Exploratory Efficacy of NEUROSTEM® in Subjects who control group of NEUROSTEM® Phase-I/IIa Clinical Trial
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NEUROSTEM (hUCB-MSCs) - high dose | Experimental | Biological: human umbilical cord blood derived mesenchymal stem cellshuman 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 |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| human umbilical cord blood derived mesenchymal stem cellsAlso: NEUROSTEMHigh dose: 3 x 10^7cells/2mL 3 repeated intraventricular administrations via an Ommaya Reservoir at 4-week intervals | Biological | NEUROSTEM (hUCB-MSCs) - high dose |
Primary outcome
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.
7 secondary outcomes
Change in CDR-SOB
Time frame: 24 weeks after the first dose
Change from the baseline in K-MMSE(korean version)
Time frame: 24 weeks after the first dose
Change from the baseline in CGA-NPI
Time frame: 24 weeks after the first dose
Change from the baseline in SIB
Time frame: 24 weeks after the first dose
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
Change in CIBIC-plus
Time frame: 24 weeks after the first dose
Change from the baseline in CSF biomarkers
Time frame: 24 weeks after the first dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
- Derived from this study: PubMed 41220869Lee 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.
Related trials for Alzheimer's Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duk L. Na, MD, PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing human umbilical cord blood derived mesenchymal stem cells in people with Alzheimer's Disease, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heejin kim, MD (+82-2-3410-1947, evekhj@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from the baseline in ADAS-Cog (time frame: 4weeks,8weeks,12weeks,24 weeks after the first dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04954534, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2021.