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

NCT02672306 | Unknown Phase 1 DMC

• 1 other identifier: UCMSC-1
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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).

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

• 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

Other Outcomes (1)

• Symptoms Checklist and Adverse Event Assessment

  From Day0（administration）to 48 weeks post-administration.

Study Arms (2)

UCMSCs

EXPERIMENTAL

Subjects with Alzheimer's Disease Intervention: UCMSCs

Biological: UCMSCs

Placebo

PLACEBO COMPARATOR

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

Biological: Placebo

Interventions

UCMSCs BIOLOGICAL

Biological: Human UCMSCs 20 million cells per subject (0.5×10\^6 UCMSCs per kg) intravenous injection Infusion number: 8 (Once every two weeks)

Also known as: Human Umbilical Cord Derived Mesenchymal

UCMSCs

Placebo BIOLOGICAL

Subjects with Alzheimer's Disease placebo comparator (normal saline) intravenous injection Infusion number: 8 (Once every two weeks)

Placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

South China Research Center for Stem Cell and Regenerative Medicine,South China Institute of Biomedicine

Guangzhou, Guangdong, 510320, China

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2016
• First Posted: February 3, 2016
• Study Start: October 20, 2017
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2019
• Last Updated: April 26, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)