The Long-Term Safety and Efficacy Follow-Up Study of Subjects Who Completed the Phase I Clinical Trial of Neurostem®-AD
1 other identifier
observational
14
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 7, 2012
CompletedFirst Posted
Study publicly available on registry
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedOctober 1, 2012
September 1, 2012
1.5 years
September 7, 2012
September 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety
Incidence rate ot adverse events (vital signs, physical examination, mixed lymphocyte reaction, and laboratory tests)
upto 24 months post-op
Secondary Outcomes (1)
Efficacy
upto 24 months post-op
Study Arms (2)
NEUROSTEM®-AD
A single administration of human umbilical cord blood-derived mesenchymal stem cells through a brain surgery DOSE A - 250,000 cells per entry site, 3 million cells per brain; DOSE B - 500,000 cells per entry site, 6 million cells per brain
Control Group
A group of subjects with comparable demographics (age and gender) and disease characteristics \[Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB)\] as the NEUROSTEM®-AD-treated group, but did not receive the treatment with NEUROSTEM®-AD and were continued on conventional therapy. Restrictions in the concurrent use of drug therapy are as follows: Patients are, in principle, permitted to continue the drug therapy they were on prior to the enrollment, for the treatment of concurrent illnesses other than Dementia, such as hypertension, diabetes mellitus, or hyperlipidemia. For drugs used in the treatment of dementia, behavior-modifying drugs can be added to the pharmacological regimen of a subject during the course of the study. However, adding a new cognitive enhancer, such as donepezil, memantine, galantamine, rivastigmine, is not permitted while dose adjustment is permitted given that the drug had been in use prior to the initiation of the study.
Interventions
NEUROSTEM®-AD was administered to eligible subjects in the early part of the Phase I clinical study. In this follow-up study, no intervention will be performed.
Eligibility Criteria
The patients, who were administered with NEUROSTEM®-AD in the earlier part of the Phase I study, will be compared with the patients, who have similar demographics and disease characteristics as the subjects in the test group but have not been treated with NEUROSTEM®-AD.
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
- 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:
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duk Lyul Nalead
- Medipost Co Ltd.collaborator
Study Sites (1)
Samsung Medical Center
Seoul, 135-710, South Korea
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
Related Links
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Duk L. Na, MD,PhD
Samsung Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of Neurology, Sungkyunkwan University School of Medicine
Study Record Dates
First Submitted
September 7, 2012
First Posted
October 1, 2012
Study Start
March 1, 2012
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
October 1, 2012
Record last verified: 2012-09