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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02672306
Recruitment Status : Active, not recruiting
First Posted : February 3, 2016
Last Update Posted : April 26, 2018
Sponsor:
Collaborators:
Guangzhou General Hospital of Guangzhou Military Command of PLA
The Third Affiliated Hospital, SUN YAT-SEN University
Information provided by (Responsible Party):
South China Research Center for Stem Cell and Regenerative Medicine

Tracking Information
First Submitted Date  ICMJE January 24, 2016
First Posted Date  ICMJE February 3, 2016
Last Update Posted Date April 26, 2018
Actual Study Start Date  ICMJE October 20, 2017
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 29, 2016)
Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)Score [ Time Frame: 10 weeks from post-administration ]
A psychometric instrument that evaluates memory, attention, reasoning, language, orientation, and praxis.
Change History Complete list of historical versions of study NCT02672306 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2018)
  • Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)Score [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 36 weeks from post-administration ]
    Plasma beta-amyloid proteins will be collected from blood samples obtained.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2016)
  • Change in Alzheimer's Disease Cooperative Study Clinician's Global Impression of Change (ADCS-CCGIC) Score [ Time Frame: 10 weeks from post-administration ]
    A systematic method for assessing clinically significant change in a clinical trial as viewed by an independent skilled and experienced clinician . The ADCS-CGIC focuses on clinician's observations of change in the subject's cognitive, functional, and behavioral performance since the beginning of a trial. It relies on both direct examination of the subject and an interview of an informant. Unlike a targeted symptom scale, it takes into account a subject's overall function in the cognitive, behavioral, and functional activity domains.
  • Change in Mini-Mental State Examination (MMSE) Score [ Time Frame: 10 weeks 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 Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) Score [ Time Frame: 10 weeks 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 [ Time Frame: 10 weeks 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 [ Time Frame: 10 weeks from post-administration ]
    Plasma beta-amyloid proteins will be collected from blood samples obtained.
  • Change from the baseline in cerebrospinal fluid (CSF) biomarkers [ Time Frame: 10 weeks from post-administration ]
    Amyloid beta and tau will be collected from CSF obtained.
Current Other Pre-specified Outcome Measures
 (submitted: April 25, 2018)
Symptoms Checklist and Adverse Event Assessment [ Time Frame: From Day0(administration)to 48 weeks post-administration. ]
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.
Original Other Pre-specified Outcome Measures
 (submitted: January 29, 2016)
Symptoms Checklist and Adverse Event Assessment [ Time Frame: 10 weeks ]
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.
 
Descriptive Information
Brief Title  ICMJE Safety and Exploratory Efficacy Study of UCMSCs in Patients With Alzheimer's Disease
Official Title  ICMJE Clinical Study on the Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Injection in the Treatment of Mild and Moderate Alzheimer's Disease
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • 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 Name: Human Umbilical Cord Derived Mesenchymal
  • Biological: Placebo
    Subjects with Alzheimer's Disease placebo comparator (normal saline) intravenous injection Infusion number: 8 (Once every two weeks)
Study Arms  ICMJE
  • Experimental: UCMSCs
    Subjects with Alzheimer's Disease Intervention: UCMSCs
    Intervention: Biological: UCMSCs
  • Placebo Comparator: Placebo
    Subjects with Alzheimer's Disease Intervention: Placebo (normal saline)
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: April 25, 2018)
16
Original Estimated Enrollment  ICMJE
 (submitted: January 29, 2016)
40
Estimated Study Completion Date  ICMJE October 2019
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02672306
Other Study ID Numbers  ICMJE UCMSC-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party South China Research Center for Stem Cell and Regenerative Medicine
Study Sponsor  ICMJE South China Research Center for Stem Cell and Regenerative Medicine
Collaborators  ICMJE
  • Guangzhou General Hospital of Guangzhou Military Command of PLA
  • The Third Affiliated Hospital, SUN YAT-SEN University
Investigators  ICMJE Not Provided
PRS Account South China Research Center for Stem Cell and Regenerative Medicine
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP