Alzheimer's DiseasePhase 1/2NCT03172117
Follow-up Study of Safety and Efficacy in Subjects Who Completed NEUROSTEM® Phase-I/IIa Clinical Trial.
A Phase 1/2 study testing human umbilical cord blood derived mesenchymal stem cells and Normal saline 2mL in people with Alzheimer's Disease, run by Medipost Co Ltd. at 1 site in South Korea.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 50 to 86 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- human umbilical cord blood derived mesenchymal stem cells and Normal saline 2mL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 May 2017to 18 Mar 2022
- Phase
- Phase 1/2
- 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 86 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Assessment of safety and exploratory treatment efficacy in subjects who were enrolled and completed phase 1/2a clinical trial of NEUROSTEM®.
- Subjects who have been treated with either NEUROSTEM® or placebo at least 12 months ago.
- 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
- Subjects who were not enrolled in phase 1/2a clinical trial of Neurostem® for assessing safety and exploratory treatment efficacy
- Other subjects, excluding those listed above, who were deemed unsuitable by the PI
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed description
The subjects will be followed up at 12-month, 24-month, and 36-month (phone call) after the initial administration of NEUROSTEM®.
- Conditions
- Alzheimer's Disease
- Being tested
- human umbilical cord blood derived mesenchymal stem cells, Normal saline 2mL
- 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®
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
Normal saline 2mLOther
Normal Saline at 4 week intervals via an Ommaya Reservoir, for a total of 3 administrations
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: human umbilical cord blood derived mesenchymal stem cells |
| 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 |
| Placebo | Placebo comparator | normal saline 2mL, doses separated by 4 weeks for a total of 3 doses Receives: Other: Normal saline 2mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from the baseline in ADAS-Cog
Alzheimer's Disease assessment Scale-Cognitive Subscale
Measured: 24 month after the first dose
Secondary outcomes (10)
Change from the baseline in S-IADL
Seoul Instrumental Activities of Daily Living
Measured: 24 month after the first dose
Change from the baseline in K-MMSE
Mini Mental State Exmination Korean version
Measured: 24 month after the first dose
Change from the baseline in CGA-NPI
Caregiver-administered Neuropsychiatric Inventory
Measured: 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
Measured: 24 month after the first dose
Change in CDR-SOB
Clinical Dementia Rating-Sum of Box
Measured: 24 month after the first dose
Change in CIBIC-plus
The Clinician's Interview Based Impression of Change-plus
Measured: 24 month after the first dose
Change in Florbetaben-PET
Florbetaben - Pittsburgh Compound B-positron emission tomography
Measured: 24 month after the first dose
Change in FDG-PET (CMRglc: regional cerebral metabolic rate for glucose)
fluorodeoxyglucose positron emission tomography
Measured: 24 month after the first dose
Change from baseline in MRI (DTI mapping)
MRI Analysis
Measured: 24 month after the first dose
Change from the baseline in CSF biomarkers
biomakrer analysis
Measured: 24 month 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 posted1 Jun 2017
- Study start19 May 2017
- Primary completion18 Mar 2022
- Study completion18 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipost Co Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03172117
- Sponsor's protocol ID
- MP-CR-010-F/U
- Status last verified
- Mar 2023
- First submitted
- 29 May 2017
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 41220869Kim 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.
PubMed 34521461
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up Study of Safety and Efficacy in Subjects Who Completed NEUROSTEM® Phase-I/IIa Clinical Trial.
- ClinicalTrials.gov ID
- NCT03172117
- Acronym / sponsor ID
- MP-CR-010-F/U
- Conditions
- Alzheimer's Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Medipost Co Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 May 2017 (actual)
- Primary completion
- 18 Mar 2022 (actual)
- Study completion
- 18 Mar 2022 (actual)
- First posted
- 1 Jun 2017 (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.
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
Detailed description
The subjects will be followed up at 12-month, 24-month, and 36-month (phone call) after the initial administration of NEUROSTEM®.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NEUROSTEM® (hUCB-MSCs)- low dose | Experimental | Biological: human umbilical cord blood derived mesenchymal stem cellshuman 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 | 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 |
| Placebo | Placebo comparator | Other: Normal saline 2mLnormal saline 2mL, doses separated by 4 weeks for a total of 3 doses |
Who may qualify
- Ages
- 50 to 86 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Assessment of safety and exploratory treatment efficacy in subjects who were enrolled and completed phase 1/2a clinical trial of NEUROSTEM®.
- Subjects who have been treated with either NEUROSTEM® or placebo at least 12 months ago.
- 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 (2 listed)
- Subjects who were not enrolled in phase 1/2a clinical trial of Neurostem® for assessing safety and exploratory treatment efficacy
- Other subjects, excluding those listed above, who were deemed unsuitable by the PI
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: NEUROSTEM®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 | Biological | NEUROSTEM® (hUCB-MSCs) - high dose, NEUROSTEM® (hUCB-MSCs)- low dose |
| Normal saline 2mLNormal Saline at 4 week intervals via an Ommaya Reservoir, for a total of 3 administrations | Other | Placebo |
Primary outcome
Change from the baseline in ADAS-Cog
Time frame: 24 month after the first dose
Alzheimer's Disease assessment Scale-Cognitive Subscale
10 secondary outcomes
Change from the baseline in S-IADL
Time frame: 24 month after the first dose
Change from the baseline in K-MMSE
Time frame: 24 month after the first dose
Change from the baseline in CGA-NPI
Time frame: 24 month after the first dose
ADAS-Cog Response Rate
Time frame: 24 month after the first dose
Change in CDR-SOB
Time frame: 24 month after the first dose
Change in CIBIC-plus
Time frame: 24 month after the first dose
Change in Florbetaben-PET
Time frame: 24 month after the first dose
Change in FDG-PET (CMRglc: regional cerebral metabolic rate for glucose)
Time frame: 24 month after the first dose
Change from baseline in MRI (DTI mapping)
Time frame: 24 month after the first dose
Change from the baseline in CSF biomarkers
Time frame: 24 month after the first dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- 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.
- Derived from this study: PubMed 34521461Kim 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing human umbilical cord blood derived mesenchymal stem cells and Normal saline 2mL in people with Alzheimer's Disease, run by Medipost Co Ltd. 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 15 Mar 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from the baseline in ADAS-Cog (time frame: 24 month 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 NCT03172117, which also lists 2 linked publications.
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 15 Mar 2023.