Stem cells for Alzheimer's: first safety check in 6 patients
NCT ID NCT04040348
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tested whether multiple infusions of donor stem cells are safe for people with mild to moderate Alzheimer's disease. Six participants received the treatment and were monitored for serious side effects and changes in thinking skills. The goal was to check safety, not to cure the disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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6 people
The number who actually took part.
- Started
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Oct 2019
- Finished
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Apr 2023
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Miami
Miami, Florida, 33136, United States
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Other studies related to the condition(s) this trial covers.
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