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

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

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).

Study Overview

• Status: Unknown
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Biological: UCMSCs; Biological: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510320
      • South China Research Center for Stem Cell and Regenerative Medicine,South China Institute of Biomedicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UCMSCs; Subjects with Alzheimer's Disease Intervention: UCMSCs	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 Names: Human Umbilical Cord Derived Mesenchymal
Placebo Comparator: Placebo; Subjects with Alzheimer's Disease Intervention: Placebo (normal saline)	Biological: Placebo; Subjects with Alzheimer's Disease placebo comparator (normal saline) intravenous injection Infusion number: 8 (Once every two weeks)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)Score	A psychometric instrument that evaluates memory, attention, reasoning, language, orientation, and praxis.	10 weeks,18 weeks,24 weeks,48weeks from post-administration
Change in Mini-Mental State Examination (MMSE) Score	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.	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
Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) Score	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).	10 weeks,18 weeks,24 weeks,36 weeks，48weeks from post-administration
Change in Neuropsychiatric Inventory (NPI) Score	The NPI is a well-validated, reliable, multi-item instrument to assess psychopathology and behavior in AD based on interview with the informant.	10 weeks,18 weeks,24 weeks,36 weeks，48weeks from post-administration
Changes in AD Biomarkers	Plasma beta-amyloid proteins will be collected from blood samples obtained.	36 weeks from post-administration

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms Checklist and Adverse Event Assessment	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.	From Day0（administration）to 48 weeks post-administration.

Collaborators and Investigators

• Sponsor: South China Research Center for Stem Cell and Regenerative Medicine
• Collaborators: Third Affiliated Hospital, Sun Yat-Sen University; Guangzhou General Hospital of Guangzhou Military Command of PLA

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2017
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): October 1, 2019

Study Registration Dates

• First Submitted: January 24, 2016
• First Submitted That Met QC Criteria: January 29, 2016
• First Posted (Estimate): February 3, 2016

Study Record Updates

• Last Update Posted (Actual): April 26, 2018
• Last Update Submitted That Met QC Criteria: April 25, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: UCMSC-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No