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

Primary Purpose

Alzheimer's Disease

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
UCMSCs
Placebo
Sponsored by
South China Research Center for Stem Cell and Regenerative Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

UCMSCs

Placebo

Arm Description

Subjects with Alzheimer's Disease Intervention: UCMSCs

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

Outcomes

Primary Outcome Measures

Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)Score
A psychometric instrument that evaluates memory, attention, reasoning, language, orientation, and praxis.

Secondary Outcome Measures

Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)Score
A psychometric instrument that evaluates memory, attention, reasoning, language, orientation, and praxis.
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.
Change in Clinician's Interview-Based Impression of Change (CIBIC-plus) Score
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).
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.
Changes in AD Biomarkers
Plasma beta-amyloid proteins will be collected from blood samples obtained.

Full Information

First Posted
January 24, 2016
Last Updated
April 25, 2018
Sponsor
South China Research Center for Stem Cell and Regenerative Medicine
Collaborators
Guangzhou General Hospital of Guangzhou Military Command of PLA, Third Affiliated Hospital, Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02672306
Brief Title
Safety and Exploratory Efficacy Study of UCMSCs in Patients With Alzheimer's Disease
Acronym
SEESUPAD
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 20, 2017 (Actual)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
October 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
South China Research Center for Stem Cell and Regenerative Medicine
Collaborators
Guangzhou General Hospital of Guangzhou Military Command of PLA, Third Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
UCMSCs
Arm Type
Experimental
Arm Description
Subjects with Alzheimer's Disease Intervention: UCMSCs
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects with Alzheimer's Disease Intervention: Placebo (normal saline)
Intervention Type
Biological
Intervention Name(s)
UCMSCs
Other Intervention Name(s)
Human Umbilical Cord Derived Mesenchymal
Intervention Description
Biological: Human UCMSCs 20 million cells per subject (0.5×10^6 UCMSCs per kg) intravenous injection Infusion number: 8 (Once every two weeks)
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Subjects with Alzheimer's Disease placebo comparator (normal saline) intravenous injection Infusion number: 8 (Once every two weeks)
Primary Outcome Measure Information:
Title
Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)Score
Description
A psychometric instrument that evaluates memory, attention, reasoning, language, orientation, and praxis.
Time Frame
36 weeks from post-administration
Secondary Outcome Measure Information:
Title
Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)Score
Description
A psychometric instrument that evaluates memory, attention, reasoning, language, orientation, and praxis.
Time Frame
10 weeks,18 weeks,24 weeks,48weeks from post-administration
Title
Change in Mini-Mental State Examination (MMSE) Score
Description
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.
Time Frame
10 weeks,18 weeks,36 weeks,24 weeks,48weeks from post-administration
Title
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
Title
Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) Score
Description
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).
Time Frame
10 weeks,18 weeks,24 weeks,36 weeks,48weeks from post-administration
Title
Change in Neuropsychiatric Inventory (NPI) Score
Description
The NPI is a well-validated, reliable, multi-item instrument to assess psychopathology and behavior in AD based on interview with the informant.
Time Frame
10 weeks,18 weeks,24 weeks,36 weeks,48weeks from post-administration
Title
Changes in AD Biomarkers
Description
Plasma beta-amyloid proteins will be collected from blood samples obtained.
Time Frame
36 weeks from post-administration
Other Pre-specified Outcome Measures:
Title
Symptoms Checklist and Adverse Event Assessment
Description
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.
Time Frame
From Day0(administration)to 48 weeks post-administration.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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 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.
Facility Information:
Facility Name
South China Research Center for Stem Cell and Regenerative Medicine,South China Institute of Biomedicine
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510320
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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