Safety and Exploratory Efficacy Study of UCMSCs in Patients With Alzheimer's Disease (SEESUPAD)
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|ClinicalTrials.gov Identifier: NCT02672306|
Recruitment Status : Active, not recruiting
First Posted : February 3, 2016
Last Update Posted : April 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Biological: UCMSCs Biological: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Clinical Study on the Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Injection in the Treatment of Mild and Moderate Alzheimer's Disease|
|Actual Study Start Date :||October 20, 2017|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||October 2019|
Subjects with Alzheimer's Disease Intervention: UCMSCs
Biological: Human UCMSCs 20 million cells per subject (0.5×10^6 UCMSCs per kg) intravenous injection Infusion number: 8 (Once every two weeks)
Other Name: Human Umbilical Cord Derived Mesenchymal
Placebo Comparator: Placebo
Subjects with Alzheimer's Disease Intervention: Placebo (normal saline)
Subjects with Alzheimer's Disease placebo comparator (normal saline) intravenous injection Infusion number: 8 (Once every two weeks)
- Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)Score [ Time Frame: 36 weeks from post-administration ]A psychometric instrument that evaluates memory, attention, reasoning, language, orientation, and praxis.
- Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)Score [ Time Frame: 10 weeks,18 weeks,24 weeks,48weeks from post-administration ]A psychometric instrument that evaluates memory, attention, reasoning, language, orientation, and praxis.
- Change in Mini-Mental State Examination (MMSE) Score [ Time Frame: 10 weeks,18 weeks,36 weeks，24 weeks,48weeks from post-administration ]A frequently used screening instrument for Alzheimer's disease drug studies. It evaluates orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons.
- Change in Clinician's Interview-Based Impression of Change (CIBIC-plus) Score [ Time Frame: 10 weeks,18 weeks,24 weeks,36 weeks，48weeks from post-administration ]
- Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) Score [ Time Frame: 10 weeks,18 weeks,24 weeks,36 weeks，48weeks from post-administration ]ADCS-ADL assesses functional performance in subjects with Alzheimer's disease. In a structured interview format, informants are queried as to whether subjects attempted each item in the inventory during the prior 4 weeks and their level of performance. The ADCS-ADL scale discriminates well between normal controls and mild AD patients. It has good test-retest reliability. The ADCS-ADL includes some items from traditional basic ADL scales (e.g., grooming, dressing, walking, bathing, feeding, toileting) as well as items from instrumental activities of daily living scales (e.g., shopping, preparing meals, using household appliances, keeping appointments, reading).
- Change in Neuropsychiatric Inventory (NPI) Score [ Time Frame: 10 weeks,18 weeks,24 weeks,36 weeks，48weeks from post-administration ]The NPI is a well-validated, reliable, multi-item instrument to assess psychopathology and behavior in AD based on interview with the informant.
- Changes in AD Biomarkers [ Time Frame: 36 weeks from post-administration ]Plasma beta-amyloid proteins will be collected from blood samples obtained.
- Symptoms Checklist and Adverse Event Assessment [ Time Frame: From Day0（administration）to 48 weeks post-administration. ]Adverse events and symptoms checklist are used to monitor signs or symptoms that may or may not be related to study medication, abnormalities detected during physical examination, or clinical significant laboratory abnormalities.
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): NCT02672306
|South China Research Center for Stem Cell and Regenerative Medicine,South China Institute of Biomedicine|
|Guangzhou, Guangdong, China, 510320|