- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03117738
A Study to Evaluate the Safety and Efficacy of AstroStem in Treatment of Alzheimer's Disease
August 7, 2021 updated by: Nature Cell Co. Ltd.
A Phase 1/2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AstroStem, Autologous Adipose Tissue Derived Mesenchymal Stem Cells, in Patients With Alzheimer's Disease
This is a randomized, double-blind, placebo-controlled, parallel-group comparison study in subjects with Alzheimer's Disease.
Following first screening period, subjects will be randomly assigned into one of the following arms: AstroStem and placebo control in a 1:1 ratio.
AstroStem or placebo control will be administered via I.V. at Week 0. This procedure will be repeated 9 times at 2-week interval.
Subjects will be scheduled for two follow-up visits at Weeks 30 and 52 to evaluate primary and secondary outcome endpoints.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
21
Phase
- 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
-
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California
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Costa Mesa, California, United States, 92626
- ATP Clinical Research
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Santa Ana, California, United States, 92705
- Syrentis Clinical Research
-
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Hawaii
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Honolulu, Hawaii, United States, 96817
- Valden Medical
-
-
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
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female subjects aged 50 and above at the time of signing the Informed Consent form
- Subjects who can understand and provide written informed consent (assent)
- Subjects who have diagnosis of probable mild-to-moderate Alzheimer disease according to NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke; Alzheimer's Disease and Related Disorders Association) criteria
- Subjects who have MMSE Score of 16 to 26 at screening
- Subjects who are taking FDA-approved AD medications (donepezil, galantamine, memantine, rivastigmine or their combinations) treatment on a stable dosage for at least 3 months prior to screening.
- Subjects who have one (or more) identified adult caregiver who is able to read, understand, and speak the designated language at the study site; either lives with the subject or sees the subject for ≥2 hours/day ≥4 days/week; and agrees to accompany the subject to each study visit
- Subjects who have a designated study partner who will accompany the subject to all clinic visits and participate in the subject's clinical assessments
Exclusion Criteria:
- Subjects who are females who are pregnant, nursing, or of childbearing potential while not practicing effective contraception
- Subjects who have signs of delirium
- Subjects who have had cortical stroke within the preceding 2 years
- Subjects who have a prolonged QTc interval; >450 msec in male or >470 msec in female at screening
- Subjects who have diagnosis of severe white matter hyperintensity (WMH), which is defined as ≥ 25mm of the deep white matter and ≥ 10mm of the periventricular capping/banding in lengths
- Subjects who have diagnosis of dementia or cause of cognitive impairment other than Alzheimer's disease
- Subjects who have a significant abnormal result in laboratory tests, in the opinion of the investigator
- Subjects who have participated in any investigational drug, stem cell therapy, or device trial within the previous 3 months at screening
- Subjects with any current psychiatric diagnosis other than AD if, in the judgment of the investigator, the psychiatric disorder or symptom is likely to confound interpretation of drug effect, affect cognitive assessments, or affect the subject´s ability to complete the study
- Subjects who are known to have autosomal dominant mutation-associated presenile AD
- Subjects who show signs of AIDS (Acquired Immunodeficiency Syndrome), HBV (Hepatitis B Virus), HCV (Hepatitis C), VDRL (Venereal Disease Research Laboratory)
- Subjects who have any conditions that would contraindicate an MRI, such as the presence metallic objects in the eyes, skin, or heart
- Subjects who have > 4 cerebral microhemorrhages (regardless of their anatomical location or diagnostic characterization as "possible" or "definite"), a single area of superficial siderosis, or evidence of a prior microhemorrhage as assessed by MRI
- Subjects who have history of malignant cancer within the last 5 years (The following is a partial list of conditions that are permissible for study entry: non-metastatic basal and/or squamous cell carcinoma of the skin, in situ cervical, or non-progressive prostate cancer)
- Subjects who have suspected active lung disease based on chest X-ray
- Subjects who are hypersensitive to fetal bovine serum or penicillin
- Subjects who are currently using immunosuppressants, cytotoxic drug, corticosteroids or similar steroidal anti-inflammatory medication (e.g., Prednisone) on a regular basis (exceptions allowed include; regular use of steroidal nasal sprays, topical steroids, and estrogen-replacement therapy)
- Subjects for whom the investigator judges the liposuction can cause any problems
- Subjects who have history of local anesthetic allergy
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: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AstroStem
|
Autologous adipose tissue derived mesenchymal stem cells (AdMSC)
|
Placebo Comparator: Placebo-Control
|
Saline with 30% auto-serum
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment Related Adverse Events
Time Frame: 30 Weeks
|
Number of subjects with treatment related adverse events as assessed by analysis of adverse events including symptoms, and abnormal findings on physical examination, vital signs, ECG, and standard laboratory examination results
|
30 Weeks
|
ADAS-Cog (Alzheimer's Disease Assessment Scale-cognitive Subscale)
Time Frame: Baseline and 30 Weeks
|
Change of ADAS-Cog (Alzheimer's Disease Assessment Scale-cognitive subscale) from Baseline at Week 30 Score range: 0-70 A score of 70 represents the most severe impairment and 0 represents the least impairment
|
Baseline and 30 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MMSE (Mini-mental Status Examination)
Time Frame: Baseline and 30 Weeks
|
Change of MMSE from baseline at Week 30 Score range: 0-30 A score of 20 to 24 suggests mild dementia, 13 to 20 suggests moderate dementia, and less than 12 indicates severe dementia.
|
Baseline and 30 Weeks
|
CDR-SOB (Clinical Dementia Rating-Sum of Boxes)
Time Frame: Baseline and 30 Weeks
|
Changes of CDR-SOB from baseline at Week 30 Score range: 0-18.0 0 = normal, 0.5-4.0
= questionable cognitive dementia, 4.5-9.0
= mild dementia, 9.5-15.5 = moderate dementia, and 16.0-18.0
= severe dementia
|
Baseline and 30 Weeks
|
NPI (Neuropsychiatric Inventory)
Time Frame: Baseline and 30 Weeks
|
Changes of NPI from baseline at Week 30 Score range: 0-144 higher score indicates higher disturbance.
|
Baseline and 30 Weeks
|
GDS (Geriatric Depression Scale)
Time Frame: Baseline and 30 Weeks
|
Changes of GDS from baseline at Week 30 Score range: 0-15 Scores of 0-4 are considered normal, depending on age, education, and complaints; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.
|
Baseline and 30 Weeks
|
ADCS-ADL (Alzheimer's Disease Cooperative Study Activities of Daily Living)
Time Frame: Baseline and 30 Weeks
|
Change of ADCS-ADL from baseline at Week 30 Score range: 0-78 Lower score indicates greater severity.
|
Baseline and 30 Weeks
|
C-SSRS (Columbia Suicide Severity Rating Scale)
Time Frame: Baseline and 30 Weeks
|
Changes of C-SSRS from baseline at Week 30 Score range: 0-25 Higher score indicates higher severity.
|
Baseline and 30 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
May 9, 2017
Primary Completion (Actual)
June 26, 2019
Study Completion (Actual)
August 31, 2019
Study Registration Dates
First Submitted
April 10, 2017
First Submitted That Met QC Criteria
April 12, 2017
First Posted (Actual)
April 18, 2017
Study Record Updates
Last Update Posted (Actual)
August 10, 2021
Last Update Submitted That Met QC Criteria
August 7, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AST-ADP2-US01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
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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