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NCT04040348 | COMPLETED | Alzheimer Disease

Alzheimer's Disease Stem Cells Multiple Infusions
Sponsor:

Bernard (Barry) Baumel

Information provided by (Responsible Party):

Bernard (Barry) Baumel

Brief 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.

Condition or disease

Alzheimer Disease

Intervention/treatment

Approximately 100 million cells allogeneic hMSC

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 6 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase I, Prospective, Open-label Trial to Evaluate the Safety, Tolerability and Exploratory Outcomes of Multiple Allogeneic Human Mesenchymal Stem Cells (HMSC) Infusions in Patients With Mild to Moderate Alzheimer's Disease
Actual Study Start Date : 2019-10-08
Estimated Primary Completion Date : 2023-04-25
Estimated Study Completion Date : 2023-04-25

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 50 Years to 85 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Alzheimer's Disease Stem Cells Multiple Infusions

Location Details

NCT04040348

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Florida

University of Miami

Miami, florida, United States, 33136