Study of Intracerebroventricular Injections of Autologous Adipose-Derived Stem Cells (RB-ADSCs) in Participants With Mild-Moderate Alzheimer's Disease

Sponsor
Regeneration Biomedical, Inc.
Study ID
NCT07205601
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
45 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • RB-ADSC — BIOLOGICAL
    RB-ADSC is an investigational an ex-vivo expanded autologous adipose-derived stem cell product
  • Placebo — OTHER
    0.9% NaCl USP

Study Details

The goal of this Phase 2 clinical trial is to learn if repeated dosing of RB-ADSC (an investigational autologous cell product obtained from participant's own adipose tissue) enhances the positive preliminary results seen in Phase 1 for the of treatment for mild to moderate Alzheimer's Disease in adults. The clinical trial will also continue to evaluate the safety of repeated dosing of RB-ADSC. This study will primarily evaluate the effects of repeated dosing of RB-ADSC on cognitive performance compared to placebo control. Participants will receive RB-ADSC every 2 months for a total of 6 doses. Participants randomized into the placebo control group will have the option to cross over to receive treatment after completion of the primary phase of the study.

Key Dates

First listed
Oct 3, 2025
Start date
Oct 31, 2026
Status verified
Aug 2026
Primary completion
Feb 28, 2029
Completion
Feb 28, 2030

Study Design

Enrollment
115 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: RB-ADSC low dose
    Participants will receive repeated doses of 2.5x10\^6 RB-ADSC infused in the previously implanted Ommaya reservoir
  • Experimental: RB-ADSC high dose
    Participants will receive repeated doses of 5x10\^6 RB-ADSC infused in the previously implanted Ommaya reservoir
  • Placebo Comparator: Placebo control
    Participants will receive placebo comparator in the previously implanted Ommaya reservoir

Primary Outcome Measure

Change from Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Composite Score [ Time Frame: Baseline, Month 6 and Month 12 ]

Central Contacts

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