CompletedNCT01297218Updated Apr 23, 2012

The Safety and The Efficacy Evaluation of NEUROSTEM®-AD in Patients With Alzheimer's Disease

A Phase 1 interventional study of Human Umbilical Cord Blood Derived-Mesenchymal Stem Cells in Dementia of the Alzheimer's Type, sponsored by Medipost Co Ltd.. Completed at 1 site in Korea, Republic of. Open to participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-04-23.

Sponsored by Medipost Co Ltd. · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 9
Allocation: Not applicable
Ages: 50 Years to 75 Years
Sex: All

Study summary

The primary purpose of this study is to evaluate the safety and the tolerability of NEUROSTEM®-AD (Human Umbilical Cord Blood Derived Mesenchymal Stem Cells) and to assess the maximum tolerated dose (MTD). This study is also to investigate the efficacy of this study drug in patients with dementia of Alzheimer's type.

Read the detailed description

Most of the treatments for Alzheimer disease are chemical drug that is designed to temporarily increase acetylcholine, based on the cholinergic hypothesis. These drugs can improve the symptoms but is not able to inhibit the disease progression. New drugs from the disease have been developed but they have not been successful yet.

Mesenchymal stem cells (MSC) are capable of differentiating into various tissues. Due to the characteristics of the cells it has been widely investigated in tissue regeneration. In addition, the paracrine effect of MSC in microenvironment has been recently reported. MSC has been developed as an immunomodulation cell therapy product because it has been known that it does not cause immunological rejection in allo- and xeno-transplantation. Clinical studies showed that umbilical cord blood-derived MSC is immunologically stable and not toxic.

This study is to evaluate the safety and the tolerability of NEUROSTEM®-AD (Human Umbilical Cord Blood Derived Mesenchymal Stem Cells) and to assess the maximum tolerated dose (MTD). This study is also to investigate the efficacy of this study drug in patients with dementia of Alzheimer's type.

Conditions studied

Dementia of the Alzheimer's Type

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Keywords

Alzheimer, Mesenchymal Stem Cells, Umbilical Cord Blood

In context

Dementia

2,172 studies on the registry are indexed under Dementia; 541 are open to participants now.

This study's enrollment of 9 is below the median of 83 across 1,629 interventional studies indexed under Dementia.

Browse Dementia studies →

Lead sponsor

Medipost Co Ltd. is the lead sponsor of 16 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 50 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Korean men and women who are age 50 or older
Dementia as determined by DSM-IV criteria
Probable alzheimer's disease as determined by NINCDS-ADRDA criteria
K-MMSE score in the range of 10 to 24
Positive result of PIB-PET imaging (SUV > 1.5,when comparing the result for the cerebellum with the result for the frontal lobe)
Voluntarily participating subject who sign the consent form

Exclusion criteria

Exclusion Criteria:

Subject with psychological diseases (i.e. depression, schizophrenia, bipolar disorder, etc)
Subject with dementia caused by other than Alzheimer's disease (i.e. infection of central nervous system, Creutzfeld-Jacob disease, severe head trauma, Pick's disease, Huntington's disease, and Parkinson's disease)
Subject with vascular dementia as determined by the clinical criteria of DSM IV and the imaging criteria of Erkinjuntii
Subject with severe white matter hyperintensities (WMH); Severe WMH is defined that length of the deep white matter is 25 mm or longer and length of the periventricular capping/banding is 10 mm or longer.
Subject who have had stroke in 3 months.
Subject with liver disease (two times higher than normal range of ALT/AST)
Subject with severe kidney failure (1.5mg/dL of serum creatinine or more)
Pregnant women or lactating women
Hemoglobin \< 9.5g/dL for men, \< 9.0 g/dL for women; Total WBC count \< 3000/mm3; Total bilirubin ≥ 3 mg/dL
Subject who is suspect to have active lung diseases, based on check X-ray result from Visit 1
Women of childbearing age who reject to practice contraception
Subject who have been excluded in the subject selection process for this study before
A platelet count \< 150,000/mm3; PT ≥ 1.5; INR or aPTT ≥ 1.5 X control
Subject with cancer
History of alcohol or drug abuse
Subject who cannot undergo MRI, CT, or PET screening
Subject who cannot undergo anesthesia or stereotactic brain injection
Subject who is determined inappropriate by the investigators

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 9 participants (actual)

Study arms

Experimental
NEUROSTEM®-AD
Biological: Human Umbilical Cord Blood Derived-Mesenchymal Stem Cells

Interventions

BiologicalHuman Umbilical Cord Blood Derived-Mesenchymal Stem Cells
DOSE A - 250,000 cells per 5 uL per 1 entry site, 3 million cells per brain DOSE B - 500,000 cells per 5 uL per 1 entry site, 6 million cells per brain
Also known as: NEUROSTEM®-AD

What researchers measure

Primary outcomes

Number of participants with Adverse event
Number of participants with adverse event, number of participants with normal range of vital signs, mixed lymphocyte reaction, and laboratory examination
Time frame: 12 weeks from post-administration

Secondary outcomes

Changes from the baseline in ADAS-cog at 12 weeks post-dose
Changes from the baseline in ADAS-cog, S-IADL, K-MMSE, CGA-NPI, ADAS-Cog, serum transthyretin, amyloid beta and tau in cerebrospinal fluid, PIB-PET and FDG-PET at 12 weeks post-dose.
Time frame: 12 weeks from post-administration

Study locations

1 site

Samsung Medical Center
Seoul, Korea, Republic of

References and documents

Publications

Kim HJ, Seo SW, Chang JW, Lee JI, Kim CH, Chin J, Choi SJ, Kwon H, Yun HJ, Lee JM, Kim ST, Choe YS, Lee KH, Na DL. Stereotactic brain injection of human umbilical cord blood mesenchymal stem cells in patients with Alzheimer's disease dementia: A phase 1 clinical trial. Alzheimers Dement (N Y). 2015 Jul 26;1(2):95-102. doi: 10.1016/j.trci.2015.06.007. eCollection 2015 Sep. PubMed 29854930 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 23, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01297218
Lead sponsor: Medipost Co Ltd.
Responsible party: Sponsor
First posted: Feb 16, 2011
Start date: Feb 2011
Primary completion: Sep 2011
Completion: Dec 2011
Last update: Apr 23, 2012

Study contacts

Duk L. Na, M.D.

principal investigator · Samsung Medical Center

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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