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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.
 
ClinicalTrials.gov Identifier: NCT03117738
Recruitment Status : Completed
First Posted : April 18, 2017
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
Nature Cell Co. Ltd.

Tracking Information
First Submitted Date  ICMJE April 10, 2017
First Posted Date  ICMJE April 18, 2017
Last Update Posted Date January 2, 2020
Actual Study Start Date  ICMJE April 3, 2017
Actual Primary Completion Date January 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2017)
  • Treatment related adverse events [ Time Frame: 32 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
  • ADAS-Cog (Alzheimer's Disease Assessment Scale-cognitive subscale) [ Time Frame: Baseline and 32 Weeks ]
    Change of ADAS-Cog from Baseline at Week 32
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03117738 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2017)
  • MMSE (Mini-mental status examination) [ Time Frame: Baseline and 32 Weeks ]
    Change of MMSE from baseline at Week 32
  • CDR-SOB (Clinical Dementia Rating-Sum of Boxes) [ Time Frame: Baseline and 32 Weeks ]
    Changes of CDR-SOB from baseline at Week 32
  • NPI (Neuropsychiatric Inventory) [ Time Frame: Baseline and 32 Weeks ]
    Changes of NPI from baseline at Week 32
  • GDS (Geriatric Depression Scale) [ Time Frame: Baseline and 32 Weeks ]
    Changes of GDS from baseline at Week 32
  • ADCS-ADL (Alzheimer's Disease Cooperative Study Activities of Daily Living) [ Time Frame: Baseline and 32 Weeks ]
    Change of ADCS-ADL from baseline at Week 32
  • C-SSRS (Columbia Suicide Severity Rating Scale) [ Time Frame: Baseline and 32 Weeks ]
    Changes of C-SSRS from baseline at Week 32
  • MRI Scan [ Time Frame: Baseline and 32 Weeks ]
    Change of MRI imaging results from baseline at Week 32
  • Biomarkers: Amyloid beta 40, Amyloid beta 42, Amyloid precursor protein intracellular domain (AICD), soluble neuregulin-1 (sNRG-1) [ Time Frame: Baseline and 32 Weeks ]
    Change of Biomarkers from baseline at Week 32
Original Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2017)
  • MMSE (Mini-mental status examination) [ Time Frame: Baseline and 32 Weeks ]
    Change of MMSE from baseline at Week 32
  • CDR-SOB (Clinical Dementia Rating-Sum of Boxes) [ Time Frame: Baseline and 32 Weeks ]
    Changes of CDR-SOB from baseline at Week 32
  • NPI (Neuropsychiatric Inventory) [ Time Frame: Baseline and 32 Weeks ]
    Changes of NPI from baseline at Week 32
  • GDS (Geriatric Depression Scale) [ Time Frame: Baseline and 32 Weeks ]
    Changes of GDS from baseline at Week 32
  • ADCS-ADL (Alzheimer's Disease Cooperative Study Activities of Daily Living) [ Time Frame: Baseline and 32 Weeks ]
    Change of ADCS-ADL from baseline at Week 32
  • C-SSRS (Columbia Suicide Severity Rating Scale) [ Time Frame: Baseline and 32 Weeks ]
    Changes of C-SSRS from baseline at Week 32
  • PET Scan [ Time Frame: Baseline and 32 Weeks ]
    Change of PET imaging results from baseline at Week 32
  • MRI Scan [ Time Frame: Baseline and 32 Weeks ]
    Change of MRI imaging results from baseline at Week 32
  • Biomarkers: Amyloid beta 40, Amyloid beta 42, Amyloid precursor protein intracellular domain (AICD), soluble neuregulin-1 (sNRG-1) [ Time Frame: Baseline and 32 Weeks ]
    Change of Biomarkers from baseline at Week 32
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety and Efficacy of AstroStem in Treatment of Alzheimer's Disease
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE
  • Drug: AstroStem
    Autologous adipose tissue derived mesenchymal stem cells (AdMSC)
  • Other: Placebo-Control
    Saline with 30% auto-serum
Study Arms  ICMJE
  • Experimental: AstroStem
    Intervention: Drug: AstroStem
  • Placebo Comparator: Placebo-Control
    Intervention: Other: Placebo-Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 8, 2019)
21
Original Estimated Enrollment  ICMJE
 (submitted: April 12, 2017)
60
Actual Study Completion Date  ICMJE June 26, 2019
Actual Primary Completion Date January 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03117738
Other Study ID Numbers  ICMJE AST-ADP2-US01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Nature Cell Co. Ltd.
Study Sponsor  ICMJE Nature Cell Co. Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Nature Cell Co. Ltd.
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP