Alzheimer's Disease Stem Cells Multiple Infusions

Completed · Phase 1

Conditions studied: Alzheimer Disease

In brief

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.

Key facts

Study ID

NCT04040348

Run by

Bernard (Barry) Baumel

People needed

6

Starts

2019-10-08

Expected to finish

2023-04-25

Last updated by the study team

2026-05-28

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All subjects enrolled in this trial must:
• Provide written informed consent
• Male or female subjects aged 50-85 years at time of signing Informed Consent
• Mini-Mental State Examination (MMSE) between 20-26
• Amyloid PET scan or CSF Aß1-42 positive for the presence of amyloid
• 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)
• 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
• Subjects already taking memantine will not have an effect in the inclusion/exclusion criteria.
• Have a study partner
• No clinically significant abnormal screening laboratory values, as determined by the investigator
• 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

You may not qualify if…

• All subjects enrolled must not have:
• Dementia other than AD
• A negative Amyloid PET scan
• Other neurodegenerative disease
• Significant psychiatric illness (e.g., uncontrolled major depression, schizophrenia, bipolar affective disorder)
• History of seizures
• Contraindication for Magnetic Resonance Imaging (MRI)
• 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
• 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
• 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.
• History of bleeding disorder
• History of or positive results for Human Immunodeficiency Virus (HIV)
• History of or positive results for Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV)
• Hypersensitivity to dimethyl sulfoxide (DMSO)
• Inability to perform any of the assessments required for endpoint analysis
• 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
• Be a transplant recipient, or on active listing (or expected future listing) for transplant of any organ.

Where it is running

• University of Miami — Miami, Florida, United States

Full record on ClinicalTrials.gov

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