ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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).

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Biological: UCMSCs Biological: Placebo Phase 1 Phase 2

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  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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
Actual Study Start Date : October 20, 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


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 Name: 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)




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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 ]
  4. 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).

  5. 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.

  6. Changes in AD Biomarkers [ Time Frame: 36 weeks from post-administration ]
    Plasma beta-amyloid proteins will be collected from blood samples obtained.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02672306


Locations
China, Guangdong
South China Research Center for Stem Cell and Regenerative Medicine,South China Institute of Biomedicine
Guangzhou, Guangdong, China, 510320
Sponsors and Collaborators
South China Research Center for Stem Cell and Regenerative Medicine
Guangzhou General Hospital of Guangzhou Military Command of PLA
The Third Affiliated Hospital, SUN YAT-SEN University

Responsible Party: South China Research Center for Stem Cell and Regenerative Medicine
ClinicalTrials.gov Identifier: NCT02672306     History of Changes
Obsolete Identifiers: NCT02513706
Other Study ID Numbers: UCMSC-1
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders