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

NCT05667649 | Recruiting Phase 1 FDA Drug

• 1 other identifier: RB-ADSC-02
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Keywords

Alzheimer's Disease; AD; Autologous; Stem cells

Outcome Measures

Primary Outcomes (1)

• The safety of RB-ADSC treatment in study participants with AD

  Safety will be determined by incidence, type and severity of adverse events (AE) and serious adverse events (SAE) graded according to CTCAE v5.0 and CRS revised grading system and defined by clinical relevant findings at every visit and week 28 post-treatment in physical examination, vital signs and laboratory data

  up to 28 weeks

Secondary Outcomes (2)

• Change from Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog)

  up to 52 weeks

• Change from Baseline in Mini Mental State Examination (MMSE)

  up to 52 weeks

Study Arms (3)

RB-ADSC low dose

EXPERIMENTAL

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

Biological: RB-ADSC

RB-ADSC medium dose

EXPERIMENTAL

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

Biological: RB-ADSC

RB-ADSC high dose

EXPERIMENTAL

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

Biological: RB-ADSC

Interventions

RB-ADSC BIOLOGICAL

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

RB-ADSC high dose; RB-ADSC low dose; RB-ADSC medium dose

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneration Biomedical, Inc.: lead

Study Sites (1)

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

RECRUITING

Related Publications (1)

• Duma C, Kopyov O, Kopyov A, Berman M, Lander E, Elam M, Arata M, Weiland D, Cannell R, Caraway C, Berman S, Scord K, Stemler L, Chung K, Khoudari S, McRory R, Duma C, Farmer S, Bravo A, Yassa C, Sanathara A, Singh E, Rapaport B. Human intracerebroventricular (ICV) injection of autologous, non-engineered, adipose-derived stromal vascular fraction (ADSVF) for neurodegenerative disorders: results of a 3-year phase 1 study of 113 injections in 31 patients. Mol Biol Rep. 2019 Oct;46(5):5257-5272. doi: 10.1007/s11033-019-04983-5. Epub 2019 Jul 20.

  PMID: 31327120 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 28, 2022
• Study Start: August 14, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)