NCT01297218

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 11, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 16, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

April 23, 2012

Status Verified

April 1, 2012

Enrollment Period

7 months

First QC Date

February 11, 2011

Last Update Submit

April 19, 2012

Conditions

Dementia of the Alzheimer's Type

Keywords

Alzheimer, Mesenchymal Stem Cells, Umbilical Cord Blood

Outcome Measures

Primary Outcomes (1)

  • 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

    12 weeks from post-administration

Secondary Outcomes (1)

  • Changes from the baseline in ADAS-cog at 12 weeks post-dose

    12 weeks from post-administration

Study Arms (1)

NEUROSTEM®-AD

EXPERIMENTAL
Biological: Human Umbilical Cord Blood Derived-Mesenchymal Stem Cells

Interventions

Human Umbilical Cord Blood Derived-Mesenchymal Stem CellsBIOLOGICAL

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
NEUROSTEM®-AD

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 29854930DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Duk L. Na, M.D.

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2011

First Posted

February 16, 2011

Study Start

February 1, 2011

Primary Completion

September 1, 2011

Study Completion

December 1, 2011

Last Updated

April 23, 2012

Record last verified: 2012-04

Locations

KR(1)