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A Study to Evaluate the Safety and Efficacy of AstroStem in Treatment of Alzheimer's Disease

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. Identifier: NCT03117738
Recruitment Status : Completed
First Posted : April 18, 2017
Results First Posted : July 9, 2021
Last Update Posted : August 10, 2021
Information provided by (Responsible Party):
Nature Cell Co. Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: AstroStem Other: Placebo-Control Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 9, 2017
Actual Primary Completion Date : June 26, 2019
Actual Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: AstroStem Drug: AstroStem
Autologous adipose tissue derived mesenchymal stem cells (AdMSC)

Placebo Comparator: Placebo-Control Other: Placebo-Control
Saline with 30% auto-serum

Primary Outcome Measures :
  1. 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

  2. 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

Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

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.

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT03117738

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United States, California
ATP Clinical Research
Costa Mesa, California, United States, 92626
Syrentis Clinical Research
Santa Ana, California, United States, 92705
United States, Hawaii
Valden Medical
Honolulu, Hawaii, United States, 96817
Sponsors and Collaborators
Nature Cell Co. Ltd.
  Study Documents (Full-Text)

Documents provided by Nature Cell Co. Ltd.:
Study Protocol  [PDF] March 4, 2019
Statistical Analysis Plan  [PDF] July 10, 2019
Informed Consent Form  [PDF] June 26, 2017

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Responsible Party: Nature Cell Co. Ltd. Identifier: NCT03117738    
Other Study ID Numbers: AST-ADP2-US01
First Posted: April 18, 2017    Key Record Dates
Results First Posted: July 9, 2021
Last Update Posted: August 10, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders