Autologous Activated Adipose-derived Stem Cells (RB-ADSC) Injected Directly Into the Brain for Mild to Moderate Alzheimer's Disease

Summary

This is a research study to evaluate the safety of an investigational autologous cell product obtained from participant's own adipose tissue as a possible treatment for Alzheimer disease.

Eligibility

Inclusion Criteria:

* ≥45 and ≤80 years of age
* Mild to moderate AD diagnosis
* Adequate cognitive function
* Non-remarkable clinical laboratory
* Ability to voluntarily provide written informed consent
* No tumors or other disease responsible for dementia
* Well-controlled comorbidities, on stable medications for 3 months
* The participant is otherwise in good general health
* The participant must have a relative/caregiver
* Participant must be able to donate adequate amount of lipoaspirate to establish the final product
* Caregiver separately meets the specified inclusion/exclusion criteria for caregivers

Exclusion Criteria:

* Taking other medications for AD, except that donepezil memantine, AChEIs including patches, Vitamin E, fish oil, and/or gingko biloba are allowed if doses have been stable for at least 3 months prior to the Screening visit
* Stem cell implantation of any type within 3 months
* Existing ventriculoperitoneal shunts
* Neurological disorders except AD
* Psychiatric disorders including schizophrenia, bipolar/unipolar depressive disorder, delirium
* Drug or alcohol abuse or dependence within the past 5 years
* Participants with a history of cancer in the past 5 years
* No caregiver available to meet the inclusion criteria for caregivers

Conditions2

Locations1 site

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