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



Status:Recruiting
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:50 - Any
Updated:6/14/2018
Start Date:April 3, 2017
End Date:July 2019
Contact:Sarah Jang, PhD
Email:sarahjang@kcrnresearch.com
Phone:301-540-2600

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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.


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
We found this trial at
3
sites
Santa Ana, California 92705
Principal Investigator: John G Duffy, MD
Phone: 714-542-3008
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Costa Mesa, California 92626
Principal Investigator: Gustavo Alva, MD
Phone: 714-277-4472
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928 Nuuanu Avenue
Honolulu, Hawaii 96817
Principal Investigator: Denis Mee-Lee, MD
Phone: 808-538-2800
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Honolulu, HI
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