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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01297218
Recruitment Status : Completed
First Posted : February 16, 2011
Last Update Posted : April 23, 2012
Sponsor:
Information provided by (Responsible Party):
Medipost Co Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dementia of the Alzheimer's Type Biological: Human Umbilical Cord Blood Derived-Mesenchymal Stem Cells Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label, Single-Center, Phase 1 Clinical Trial to Evaluate the Safety and the Efficacy of NEUROTSTEM®-AD in Patients With Dementia of the Alzheimer's Type
Study Start Date : February 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: NEUROSTEM®-AD Biological: Human 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
Other Name: NEUROSTEM®-AD


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with Adverse event [ Time Frame: 12 weeks from post-administration ]
    Number of participants with adverse event, number of participants with normal range of vital signs, mixed lymphocyte reaction, and laboratory examination


Secondary Outcome Measures :
  1. Changes from the baseline in ADAS-cog at 12 weeks post-dose [ Time Frame: 12 weeks from post-administration ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01297218


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Medipost Co Ltd.
Investigators
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Principal Investigator: Duk L. Na, M.D. Samsung Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medipost Co Ltd.
ClinicalTrials.gov Identifier: NCT01297218    
Other Study ID Numbers: MP-CR-007
First Posted: February 16, 2011    Key Record Dates
Last Update Posted: April 23, 2012
Last Verified: April 2012
Keywords provided by Medipost Co Ltd.:
Alzheimer, Mesenchymal Stem Cells, Umbilical Cord Blood
Additional relevant MeSH terms:
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Dementia
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Neurocognitive Disorders
Mental Disorders
Tauopathies
Neurodegenerative Diseases