Alzheimer's Disease Stem Cells Multiple Infusions

NCT ID: NCT04040348

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-08
• Study Completion Date: 2023-04-25

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.

Conditions

Alzheimer Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

hMSC Treatment group

Participants in the hMSC treatment group will receive a total of 4 doses of the hMSC intervention. Each dose will be administered once about every 13 weeks within a year period.

Group Type: EXPERIMENTAL

Approximately 100 million cells allogeneic hMSC

Intervention Type: BIOLOGICAL

Umbilical cord-derived, allogeneic hMSC administered intravenously at a dose of approximately 100 million cells per infusion.

Interventions

Approximately 100 million cells allogeneic hMSC

Umbilical cord-derived, allogeneic hMSC administered intravenously at a dose of approximately 100 million cells per infusion.

Intervention Type: BIOLOGICAL

Eligibility 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

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

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bernard (Barry) Baumel

OTHER

Sponsor Role: lead

Responsible Party

Bernard (Barry) Baumel

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Bernard (Barry) Baumel, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Countries

United States

Other Identifiers

20190438

Identifier Type: -

Identifier Source: org_study_id