Exploratory Efficacy Study of NEUROSTEM® in Subjects Who Control Group of NEUROSTEM®
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04954534|
Recruitment Status : Not yet recruiting
First Posted : July 8, 2021
Last Update Posted : July 14, 2021
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Biological: human umbilical cord blood derived mesenchymal stem cells||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Exploratory Efficacy Study of NEUROSTEM® in Subjects Who Control Group of NEUROSTEM® Phase-I/IIa Clinical Trial|
|Estimated Study Start Date :||July 12, 2021|
|Estimated Primary Completion Date :||January 31, 2022|
|Estimated Study Completion Date :||June 30, 2022|
Experimental: NEUROSTEM (hUCB-MSCs) - high dose
human umbilical cord blood-derived mesenchymal stem cells High dose: 3 x 10^7 cells/2mL 3 repeated intraventricular administrations via an Ommaya Reservoir at 4-week intervals
Biological: human umbilical cord blood derived mesenchymal stem cells
High dose: 3 x 10^7cells/2mL 3 repeated intraventricular administrations via an Ommaya Reservoir at 4-week intervals
Other Name: NEUROSTEM
- Change from the baseline in ADAS-Cog [ Time Frame: 4weeks,8weeks,12weeks,24 weeks after the first dose ]The ADAS-Cog is a psychometric instrument that evaluates memory, attention, reasoning, language, orientation, and praxis using an 11-point AD Assessment Scale. It has a minimum score of 0 and a maximum severity score of 70, and a higher score indicates more impairment.
- Change in CDR-SOB [ Time Frame: 24 weeks after the first dose ]The CDR-SOB(Clinical Dementia Rating, Sum of Boxes) is a global rating of dementia severity based on the clinician's interpretation of the history and examination. The range of this instrument is 0 to 18 with higher numbers indicating greater impairment.
- Change from the baseline in K-MMSE(korean version) [ Time Frame: 24 weeks after the first dose ]The MMSE(Mini-Mental State Examination) is a brief, practical test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language) and results in a total possible score from 0 to 30, with higher scores indicating better function
- Change from the baseline in CGA-NPI [ Time Frame: 24 weeks after the first dose ]Caregiver-administered Neuropsychiatric Inventory, Measure abnormal behavior. The score range is 0-144. A higher score means severe abnormal behavior.
- Change from the baseline in SIB [ Time Frame: 24 weeks after the first dose ]The Severe Impairment Battery (SIB) is an assessment of cognitive dysfunction across nine domains such as memory, language, and orientation. The score ranges from 0 (worst) to 100 (best)
- ADAS-Cog Response Rate [ Time Frame: The ADAS-cog response is defined as no worsening (no change or improvement on ADAS-cog score) of the ADAS-cog score at 24 weeks after the first administration compared to the baseline ]Alzheimer's Disease assessment Scale-Cognitive Subscale
- Change in CIBIC-plus [ Time Frame: 24 weeks after the first dose ]The Clinician's Interview-Based Impression of Change-plus(CIBIC-plus) is a rating scale derived from an interview with the patient and caregiver with an independent rater designed to measure several domains of patient function, such as mental/cognitive state, behavior, and activities of daily living. The scores range from 1 (marked improvement) to 7 (marked worsening).
- Change from the baseline in CSF biomarkers [ Time Frame: 24 weeks after the first dose ]biomakrers analysis (Amyloid beta 42, Phosphorylated tau, Total tau, RBC, WBC, Protein, Glucose)
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): NCT04954534
|Contact: Heejin kim, MDemail@example.com|
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Korea, Republic of, 135-710|
|Principal Investigator:||Duk L. Na, MD, PhD||Samsung Medical Center|