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

Description

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

Alzheimer Disease

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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

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

Condition
Alzheimer Disease
Intervention / Treatment

-

Contacts and Locations

Newport Beach

Hoag Memorial Hospital Presbyterian, Newport Beach, California, United States, 92663

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

45 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Regeneration Biomedical, Inc.,

Study Record Dates

2025-03