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

This study is not yet open for participant recruitment.
Verified January 2016 by South China Research Center for Stem Cell and Regenerative Medicine
Sponsor:
ClinicalTrials.gov Identifier:
NCT02672306
First Posted: February 3, 2016
Last Update Posted: February 3, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Third Affiliated Hospital, Sun Yat-Sen University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou Psychiatric Hospital
Information provided by (Responsible Party):
South China Research Center for Stem Cell and Regenerative Medicine
  Purpose
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 Intervention Phase
Alzheimer's Disease Biological: UCMSCs Biological: Placebo Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Safety and Exploratory Efficacy Study of UCMSCs in Patients With Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by South China Research Center for Stem Cell and Regenerative Medicine:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 40
Study Start Date: May 2016
Estimated Study Completion Date: October 2019
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Other Name: Normal saline

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
  Eligibility

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, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A diagnosis of probable AD and Mixed Dementia according to the criteria of the NINCDS-ADRDA
  • History of cognitive decline that had been gradual in onset and progressive over at least 6 months
  • MMSE score between 3 and 20, both inclusive
  • Home monitoring available for supervision of medications
  • Voluntarily participating subject who sign the Inform Concent

Exclusion Criteria:

  • Subject with positive test for Human Immunodeficiency Virus(HIV)
  • Subject who cannot undergo Magnetic Resonance Imaging(MRI), computed tomography(CT) screening
  • Subject with psychological diseases (i.e. depression, schizophrenia, bipolar disorder, etc)
  • Subject with cancer
  • Subject with dementia caused by other than Alzheimer's disease (i.e. infection of central nervous system, Creutzfeldts-Jacob disease, severe head trauma, Pick's disease, Huntington's disease, and Parkinson's disease)
  • Subject with severe white matter hyperintensities (WMH); Severe WMH is defined that length of the deep white matter is 25 mm or longer and length of the periventricular capping/banding is 10 mm or longer
  • Subject who have had stroke in 3 months
  • Subject with severe kidney failure (1.5 mg/dL of serum creatinine or more) Hemoglobin < 9.5 g/dL for men, < 9.0 g/dL for women; Total white blood count < 3000/mm3; Total bilirubin ≥ 3 mg/dL
  • Active hepatic or renal disease
  • Subject who have been excluded in the subject selection process for this study before
  • Subject who is determined inappropriate by the investigators
  • Subject who is allergic constitution
  • History of screening failure for the clinical trial of neural stem cells
  • A platelet count < 150,000/mm3; Plasma prothrombin time(PT)≥ 1.5; the international normalized ratio (INR) or activated partial thromboplastin time(aPTT)≥ 1.5 x control value
  • Participation in another clinical trial within the three months prior to the beginning (Week 0) of this clinical trial
  Contacts and Locations
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


Contacts
Contact: Xuetao Pei, M.D., Ph.D 8610-68164807 AMMS0906@163.com
Contact: Yali Jia, Ph.D 8620-89199011 jiayali@scrm.org.cn

Sponsors and Collaborators
South China Research Center for Stem Cell and Regenerative Medicine
Third Affiliated Hospital, Sun Yat-Sen University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou Psychiatric Hospital
  More Information

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 Submitted: January 24, 2016
First Posted: February 3, 2016
Last Update Posted: February 3, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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