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

Part of paid clinical trials in Newport Beach, California.

Sponsor
Regeneration Biomedical, Inc.
Study ID
NCT05667649
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
45 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • RB-ADSC — BIOLOGICAL
    Ex Vivo Expanded, Autologous Adipose-Derived Stem Cells (ADSCs)

Study Details

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.

Key Dates

Start date
Aug 14, 2023
Status verified
Apr 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
18 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Locations (1)

FacilityCityStateZIPSite coordinators
Hoag Memorial Hospital PresbyterianNewport BeachCalifornia92663
Robert Lynn
[email protected]
877-240-1660

Find similar trials in Newport Beach, CA

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Hoag Memorial Hospital Presbyterian· Newport Beach, CA

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