RecruitingPhase 1NCT05667649

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

Ph 1, Open-Label Safety Study of Escalating Doses of Intracerebroventricular Injections of Ex Vivo Expanded, Autologous ADSCs in Participants With Mild-Moderate AD Whose Treatment is Not Addressed Adequately by Available Therapy

Sponsor

Regeneration Biomedical, Inc.

Enrollment

18 participants

Start Date

Aug 14, 2023

Study Type

INTERVENTIONAL

Conditions

Alzheimer 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

Min Age: 45 YearsMax Age: 80 Years

Inclusion Criteria10

≥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

Exclusion Criteria7

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