Safety and Exploratory Efficacy Study of UCMSCs in Patients With Alzheimer's Disease

Phase 1

• Conditions: Alzheimer's Disease
• Interventions: Biological: UCMSCs; Biological: Placebo

• Registration Number: NCT02672306
• Lead Sponsor: South China Research Center for Stem Cell and Regenerative Medicine

Brief Summary

The primary purpose of this study is to evaluate the safety and the efficacy of (Human Umbilical Cord-Derived Mesenchymal Stem Cells) UCMSCs for patients with Alzheimer's disease (AD).

Detailed Description

Study Type: Interventional Study Design: Treatment, Parallel Assignment, Double Blind (Subject, Outcomes Assessor), Randomized, Safety/ Efficacy Study Official Title: Multicenter, Randomized, Double-blind, Placebo Controlled Trial of UCMSCs in Subjects With Alzheimer's Disease

Study Timeline

• Study First Submitted: 2016-01-24
• Study First Submitted QC: 2016-01-29
• Study First Posted: 2016-02-03
• Study Start: 2017-10-20
• Status Verified: 2018-02
• Last Update Submitted: 2018-04-25
• Last Update Posted: 2018-04-26
• Primary Completion: 2018-10
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UCMSCs	UCMSCs	Subjects with Alzheimer's Disease Intervention: UCMSCs
Placebo	Placebo	Subjects with Alzheimer's Disease Intervention: Placebo (normal saline)

Primary Outcome Measures

Name	Time	Method
Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)Score	36 weeks from post-administration	A psychometric instrument that evaluates memory, attention, reasoning, language, orientation, and praxis.

Secondary Outcome Measures

Name	Time	Method
Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) Score	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	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	36 weeks from post-administration	Plasma beta-amyloid proteins will be collected from blood samples obtained.
Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)Score	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	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	10 weeks,18 weeks,24 weeks,36 weeks，48weeks from post-administration

Trial Locations

Locations (1)

South China Research Center for Stem Cell and Regenerative Medicine,South China Institute of Biomedicine; 🇨🇳 Guangzhou, Guangdong, China