Actively Recruiting

Phase 1
Age: 45Years - 80Years
All Genders
NCT05667649

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

Led by Regeneration Biomedical, Inc. · Updated on 2025-04-04

18

Participants Needed

1

Research Sites

154 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 45Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be between 45 and 80 years old
  • Have a diagnosis of mild to moderate Alzheimer's disease
  • Have adequate cognitive function
  • Have normal results on clinical laboratory tests
  • Be able to voluntarily provide written informed consent
  • Have no tumors or other diseases causing dementia
  • Have well-controlled other health conditions and stable medications for at least 3 months
  • Be generally in good health
  • Have a relative or caregiver available
  • Be able to donate enough fat tissue for stem cell preparation
  • Caregiver must meet specific inclusion and exclusion criteria
Not Eligible

You will not qualify if you...

  • Taking Alzheimer's medications other than donepezil, memantine, AChE inhibitors including patches, Vitamin E, fish oil, or gingko biloba unless doses have been stable for at least 3 months
  • Received any stem cell implantation within the past 3 months
  • Have existing ventriculoperitoneal shunts
  • Have neurological disorders other than Alzheimer's disease
  • Have psychiatric disorders such as schizophrenia, bipolar or unipolar depression, or delirium
  • Have a history of drug or alcohol abuse or dependence within the past 5 years
  • Have had cancer within the past 5 years
  • Do not have a caregiver who meets the caregiver criteria

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States, 92663

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

3

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