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

April 25, 2018 updated by: South China Research Center for Stem Cell and Regenerative Medicine

Clinical Study on the Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Injection in the Treatment of Mild and Moderate Alzheimer's Disease

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510320
        • South China Research Center for Stem Cell and Regenerative Medicine,South China Institute of Biomedicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
36 weeks from post-administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
10 weeks,18 weeks,24 weeks,48weeks from post-administration
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.
10 weeks,18 weeks,36 weeks，24 weeks,48weeks from post-administration
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
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).
10 weeks,18 weeks,24 weeks,36 weeks，48weeks from post-administration
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.
10 weeks,18 weeks,24 weeks,36 weeks，48weeks from post-administration
Changes in AD Biomarkers
Time Frame: 36 weeks from post-administration
Plasma beta-amyloid proteins will be collected from blood samples obtained.
36 weeks from post-administration

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
From Day0（administration）to 48 weeks post-administration.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
South China Research Center for Stem Cell and Regenerative Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou General Hospital of Guangzhou Military Command of PLA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 20, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 3, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 26, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UCMSC-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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