The Long-Term Safety and Efficacy Follow-Up Study of Subjects Who Completed the Phase I Clinical Trial of Neurostem®-AD
Information source: Samsung Medical Center
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Delirium, Dementia, Amnestic, Cognitive Disorders; Mental Disorders
Intervention: NEUROSTEM®-AD (Biological)
Phase: N/A
Status: Recruiting
Sponsored by: Duk Lyul Na Official(s) and/or principal investigator(s): Duk L. Na, MD,PhD, Principal Investigator, Affiliation: Samsung Medical Center
Overall contact: Duk-Lyul Na, MD, PhD, Phone: +82-2-3410-3594, Email: dukna@naver.com
Summary
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.
Clinical Details
Official title: The Long-Term Safety and Efficacy Follow-up Study of Subjects Who Completed the Phase I Clinical Trial of Neurostem®-AD
Study design: Observational Model: Case Control, Time Perspective: Prospective
Primary outcome: Safety
Secondary outcome: Efficacy
Detailed description:
This is a long-term follow up study of the earlier part of the phase I, during which the
safe and effective dose(safety) of NEUROSTEM®-AD was determined for implantation into the
brains of subjects with Dementia of the Alzheimer's type. Subjects with Dementia of the
Alzheimer's type, who signed the informed consent form and meet the eligibility criteria,
were implanted with a single dose of NEUROSTEM®-AD, hUBC-MSCs, into the brain. The subjects
were hospitalized for 5 to 10 days following the surgical implantation and were observed for
acute adverse events: Gradient echo MRI within the the 24 hours post-op, vital signs,
clinical laboratory tests, chest x-rays within Day 2. On Day 14, DLT was assessed, and the
subjects were followed up on the safety and disease progression of dementia (of the
Alzheimer's type) for 12 weeks post-implantation.
In this part of the study, the subjects described above will be followed-up for upto Month
24, and 3 additional subjects with comparable demographics and disease characteristics as
the treatment group (refer to Inclusion/Exclusion Criteria) will be enrolled as a control
group, followed up for 3 months and compared with the treatment group for various indicators
of the disease progression.
Eligibility
Minimum age: 50 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Duk-Lyul Na, MD, PhD, Phone: +82-2-3410-3594, Email: dukna@naver.com
Samsung Medical Center, Seoul 135-710, Korea, Republic of; Recruiting Duk L. Na, MD, PhD, Phone: +82-2-3410-3594, Email: dukna@naver.com
Additional Information
The Safety and The Efficacy Evaluation of NEUROSTEM®-AD in Patients With Alzheimer's Disease
Starting date: March 2012
Last updated: September 27, 2012
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