Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
The purpose of this research study is to test the safety, possible side effects, and possible
effectiveness of mesenchymal stem cell infusions when given to people with a diagnosis of
mild to moderate Alzheimer's disease.
Phase
Phase 1
Funding Agency/Sponsor
Other
Disease
Other
Enrollment Eligibility
Inclusion Criteria:
All subjects enrolled in this trial must:
1. Provide written informed consent
2. Male or female subjects aged 50-85 years at time of signing Informed Consent
3. Mini-Mental State Examination (MMSE) between 20-26
4. Amyloid PET scan or CSF Aß1-42 positive for the presence of amyloid
5. Meet criteria for either Alzheimer's Disease or probable Alzheimer's Disease (AD)
according to National Institute of Neurological and Communicative Disorders and
Stroke/Alzheimer's Disease and Related Disorders Association (NINDCDS/ARDRA)
6. Subjects, if taking cholinesterase inhibitor medications (donepezil, rivastigmine
(oral or transdermal) or galantamine), are required to have been taking them on a
stable dose for at least 3 months prior to Baseline Visit These medicines are not
required
7. Subjects already taking memantine will not have an effect in the inclusion/exclusion
criteria.
8. Have a study partner
9. No clinically significant abnormal screening laboratory values, as determined by the
investigator
10. Women must be postmenopausal, surgically sterile, or having infertility. A
postmenopausal woman is defined as either having an intact uterus with at least 12
months of spontaneous amenorrhea or a diagnosis of menopause, defined as an Follicular
Stimulating Hormone (FSH) level of > 25 IU/L
Exclusion Criteria:
All subjects enrolled must not have:
1. Dementia other than AD
2. A negative Amyloid PET scan
3. Other neurodegenerative disease
4. Significant psychiatric illness (e.g., uncontrolled major depression, schizophrenia,
bipolar affective disorder)
5. History of seizures
6. Contraindication for Magnetic Resonance Imaging (MRI)
7. History of malignancy, except:
- > 5 years in remission prior to screening
- Be excised or treated basal cell, squamous carcinoma or melanoma in situ
- Prostate cancer in situ
- Cervical carcinoma in situ
8. Uncontrolled medical conditions
- Hypertension
- Diabetes
- Unstable angina or history of Myocardial Infarction (MI) within 1 year prior to
screening
- History of alcohol or drug use disorder (except tobacco use disorder) within 2
years before the screening visit
9. Brain MRI at screening that shows evidence of findings incompatible with a diagnosis
of Alzheimer's disease. Volumetric MRI scans done within 6 months prior to ICF
signature will be accepted if completed locally.
10. History of bleeding disorder
11. History of or positive results for Human Immunodeficiency Virus (HIV)
12. History of or positive results for Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV)
13. Hypersensitivity to dimethyl sulfoxide (DMSO)
14. Inability to perform any of the assessments required for endpoint analysis
15. Currently receiving (or received within four weeks of screening) experimental agents
for the treatment of AD or enrolled in clinical trials in the prior 3 months
16. Be a transplant recipient, or on active listing (or expected future listing) for
transplant of any organ.
17. Any other condition that, in the opinion of the investigator, may compromise the
safety or compliance of the patient or preclude successful completion of the study.