Clinical Trial Details

NCT ID: NCT01696591
Date Last Changed: September 27, 2012

Overview

Research Study Summary

A clinical study for patients using NEUROSTEM®-AD

Research Study Title

The Long-Term Safety and Efficacy Follow-up Study of Subjects Who Completed the Phase I Clinical Trial of Neurostem®-AD

Purpose

The purpose of the study is to determine the long-term safety and exploratory efficacy of NEUROSTEM®-AD, administered via an open brain surgery to subjects with dementia of the Alzheimer's type, who were eligible for and enrolled in the earlier part of the phase I. Aside from the subjects who completed the earlier part of the Phase I, 3 additional subjects with comparable demographics and disease characteristics as the treatment group will be enrolled into a control group, followed-up for 3 months, and compared for various disease progression indicators with the treatment group.

The hypothesis is that NEUROSTEM®-AD is safe and effective in the treatment of dementia of the Alzheimer's type.

To Learn more

Recruitment Details

Gender
Both Male and Female
Age
50 to 75 Years
Overall Status
Recruiting
Lead Sponsor
Duk Lyul Na
Duration
18 Months
Facility Type
N/A
Compensation

Eligibility

Both Male and Female ages 50 Years to 75 Years

TEST GROUP

Inclusion Criteria:

  • Subjects who have enrolled and completed the Phase I cliical trial: The Safety and The Efficacy Evaluation of NEUROSTEM®-AD in Patients With Alzheimer's Disease

  • Subjects who are willing to participate in the study and sign the consent form

Exclusion Criteria:

  • Females who are pregnant or nursing

  • Subjects who have participated in another clinical study within the 3 months prior to the initiation of this study

  • Subjects who are restricted from undergoing exams perfomed during the study (i.e. MRI, CT, or PET screening)

  • Subjects who the principal investigator considers inappropriate for participation in the study due to any reasons other than those listed above

CONTROL GROUP

Inclusion Criteria:

  • Patients with a moderate alzheimer's disease, diagnosed with a dementia of alzheimer's type, according to the DSM-VI and NINCDS-ADRDA criteria, and shows amyloid-positive in a PIB-PET

Exclusion Criteria:

  • Subjects with a psychological disease (i.e. depression, schizophrenia, bipolar disorder, etc)

  • Subjects with a dementia caused by other degenerative neurological diseases (infection of the CNS, such as HIV or Syphilis), head trauma, Creutzfeld-Jacob disease, Pick's disease, Huntington's disease, and Parkinson's disease)

  • Subjects with a vascular dementia as determined by the clinical criteria of DSM IV and the imaging criteria of Erkinjuntii

  • Subjects with severe white matter hyperintensities (WMH); Severe WMH is defined as, according to Clinical Research Center for Dementia of South Korea, a condition in which the deep white matter is 25 mm or greater and the periventricular capping/banding is 10 mm or greater in lengths.

  • Subjects with a history of stroke within the 3 months prior to the study enrollment

  • Subjects with a severe liver disease (ALT/AST values are higher than twice the normal range)

  • Subjects with a severe renal disease (1.5mg/dL or more of serum creatinine)

  • Pregnant or lactating women

  • Subjects with abnormal findings of the clinical laboratory values at Visit 1:

  • Hemoglobin < 9.5g/dL in male < 9.0 g/dL in female

  • Total WBC count < 3000/mm3

  • Total bilirubin ≥ 3 mg/dL

  • Subjects with a suspected active lung disease, based on the chest X-ray result at Visit 1

  • Females of childbearing age who does not practice medically acceptable method of contraception during the study

  • Subjects who have previously failed Screening for participation in this study

  • Subjects who have participated in another clinical study within the 3 months prior to the initiation of this study

  • Subjects with a bleeding disorder (platelet count < 150,000/mm3; PT ≥ 1.5; INR or aPTT ≥ 1.5 X control

  • Subjects with a cancer (including brain tumor)

  • Subjects with a history of alcohol or drug abuse

  • Subjects who are restricted from undergoing exams perfomed during the study (i.e. MRI, CT, or PET screening)

  • Patients who the principal investigator considers inappropriate for participation in the study due to any reasons other than those listed above

Site Locations (1)

Country State City Zip Facility and Contact
Korea, Republic of Seoul 135-710 Samsung Medical Center
Duk L. Na, MD, PhD
+82-2-3410-3594
dukna@naver.com

Contact

Duk-Lyul Na, MD, PhD
+82-2-3410-3594
E-mail:

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