Recruiting
Phase 1

RB-ADSC

Sponsor:

Regeneration Biomedical, Inc.

Code:

NCT05667649

Conditions

Alzheimer Disease

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

RB-ADSC

Study Details

Brief 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.

Conditions

Alzheimer Disease

Study ID

NCT05667649

Start date

Aug 14, 2023

Status verified date

Apr, 2025

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

18 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: RB-ADSC low dose

Participants will receive one dose of 2x10\^6 RB-ADSC infused in the previously implanted Ommaya reservoir

experimental: RB-ADSC medium dose

Participants will receive one dose of 5x10\^6 RB-ADSC infused in the previously implanted Ommaya reservoir

experimental: RB-ADSC high dose

Participants will receive one dose of 10x10\^6 RB-ADSC infused in the previously implanted Ommaya reservoir

Interventions

RB-ADSC

Ex Vivo Expanded, Autologous Adipose-Derived Stem Cells (ADSCs)

Primary outcome measure

  • The safety of RB-ADSC treatment in study participants with AD [ Time Frame: up to 28 weeks ]

Central Contacts and Locations

Locations

Hoag Memorial Hospital Presbyterian

Recruiting

Newport Beach, California, United States, 92663

Contacts

Robert Lynn

877-240-1660robert@regenerationbiomedical.com

More Information

Sponsor

Regeneration Biomedical, Inc.

Last update posted

Apr 4, 2025

Last verified

Apr, 2025

Keywords

  • Alzheimer's Disease
  • AD
  • Autologous
  • Stem cells

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Regeneration Biomedical, Inc. on 2025-04-04.