Safety and Exploratory Efficacy Study of UCMSCs in Patients With Alzheimer's Disease (SEESUPAD)
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ClinicalTrials.gov Identifier: NCT02672306 |
Recruitment Status : Unknown
Verified February 2018 by South China Research Center for Stem Cell and Regenerative Medicine.
Recruitment status was: Active, not recruiting
First Posted : February 3, 2016
Last Update Posted : April 26, 2018
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Condition or disease | Intervention/treatment | Phase |
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Alzheimer's Disease | Biological: UCMSCs Biological: Placebo | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 16 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Care Provider) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: UCMSCs
Subjects with Alzheimer's Disease Intervention: UCMSCs
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Biological: 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)
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Biological: Placebo
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.

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Ages Eligible for Study: | 50 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Ages 50 to 80, male and female.
- A diagnosis of probable AD and Mixed Dementia according to the criteria of the NINCDS-ADRDA
- Treatment with other cholinesterase inhibitors, such as a stable dose of donnepiazide tablets (5mg/ day or 10mg/ day) or the use of heavy tartaric acid karbalin capsules, is currently being used.
- MMSE score between 10 and 26.
- Voluntarily participating subject who sign the Inform Concent
Exclusion Criteria:
- Caused by other reasons of dementia (vascular dementia, infectious disease of the central nervous system (such as HIV, syphilitic dementia), g - she's disease, Parkinson's disease, Lou gehrig's disease, huntington's disease DLB, traumatic brain dementia, other physical and chemical factors (such as: drug poisoning, alcoholism, carbon monoxide poisoning and other dementia), important body disease (such as hepatic encephalopathy, pulmonary encephalopathy dementia), intracranial placeholder lesions, endocrine system disease, such as thyroid disease, parathyroid disease), and vitamins and other causes of dementia)
- The Hamilton depression scale (HAMD) score > 17, or patients with a history of depression or other psychiatric or psychiatric disorders.
- The Hachinski ischemic index scale (HIS) scored > 4.
- The brief intelligence status examination scale (MMSE) score of 10 patients.
- Liver function (ALT, AST) exceeded the normal range limit of 1.5 times, SCr exceeded normal range upper limit, white blood cell count < 4.0 x 109/L or platelet < 100 x 109/L, hemoglobin < 100g/L.
- Patients with type 1 diabetes, obstructive pulmonary disease (copd) or asthma, vitamin B12 or folate deficiency patients, not control good digestion, liver, kidney, endocrine and cardiovascular system diseases (especially sick sinus syndrome and conduction block), patients with HIV/AIDS, syphilis, active tuberculosis, etc.
- A person with cancer or a history of cancer.
- People with a clinically significant history of stroke, who have had a seizure or a head injury in the past two years, have caused the disorder.
- There is a history of congestive heart failure or a history of myocardial infarction, and a blood disease in two years.
- Drug clinical trials were performed within 3 months of screening.
- Anti-ad agents are being used in addition to the programme requirements.
- The use of stem cell therapy in half a year.
- People with history of alcoholism and substance abuse, allergies, or history of allergies.
- Patients who had been hospitalized for more than 3 months before screening. of allergies.
- The researchers think it is inappropriate to participate in this clinical trial.

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
China, Guangdong | |
South China Research Center for Stem Cell and Regenerative Medicine,South China Institute of Biomedicine | |
Guangzhou, Guangdong, China, 510320 |
Responsible Party: | South China Research Center for Stem Cell and Regenerative Medicine |
ClinicalTrials.gov Identifier: | NCT02672306 |
Obsolete Identifiers: | NCT02513706 |
Other Study ID Numbers: |
UCMSC-1 |
First Posted: | February 3, 2016 Key Record Dates |
Last Update Posted: | April 26, 2018 |
Last Verified: | February 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |