Clinical Study on the Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Injection in the Treatment of Mild and Moderate Alzheimer's Disease

South China Research Center for Stem Cell and Regenerative Medicine1 site in 1 country16 target enrollmentOctober 20, 2017

ConditionsAlzheimer's Disease

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Alzheimer's Disease
Sponsor: South China Research Center for Stem Cell and Regenerative Medicine
Enrollment: 16
Locations: 1
Primary Endpoint: Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)Score
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

October 20, 2017

End Date

October 2019

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

South China Research Center for Stem Cell and Regenerative Medicine

Responsible Party

Sponsor

Eligibility Criteria

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
•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 \>
•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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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)
Change in Neuropsychiatric Inventory (NPI) Score(10 weeks,18 weeks,24 weeks,36 weeks，48weeks from post-administration)
Changes in AD Biomarkers(36 weeks from post-administration)
Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)Score(10 weeks,18 weeks,24 weeks,48weeks from post-administration)
Change in Mini-Mental State Examination (MMSE) Score(10 weeks,18 weeks,36 weeks，24 weeks,48weeks from post-administration)
Change in Clinician's Interview-Based Impression of Change (CIBIC-plus) Score(10 weeks,18 weeks,24 weeks,36 weeks，48weeks from post-administration)