Repeat Intracerebroventricular Injections of RB-ADSC in Subjects Previously Treated in RBI Protocol RB-ADSC-02

Sponsor
Regeneration Biomedical, Inc.
Study ID
NCT07373067
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
45 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

This is a Phase 1b Extension Trial to allow repeat intracerebroventricular injections of RB-ADSCs in subjects previously treated in and successfully completed RBI Protocol RB-ADSC-02. In the previous Phase 1 clinical trial, RB-ADSC-02, subjects with mild to moderate Alzheimer's disease (AD) received a single intraventricular injection of RB-ADSC. RB-ADSC will be delivered intracerebroventricularly every 2 months via the previously implanted Ommaya reservoir for up to 6 injections in total. The primary objective of safety is performed 2 months after the last dose administration at the month 12 follow-up visit. The secondary objective endpoint evaluations of efficacy are performed at the month 6 and 12 visits.

Key Dates

First listed
Jan 28, 2026
Start date
Jan 31, 2026
Status verified
Jan 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
9 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: RB-ADSC low dose
    Participants will receive 2x10\^6 RB-ADSC infused in the previously implanted Ommaya reservoir every 2 months for up to a total of 6 doses
  • Experimental: RB-ADSC medium dose
    Participants will receive 5x10\^6 RB-ADSC infused in the previously implanted Ommaya reservoir every 2 months for up to a total of 6 doses
  • Experimental: RB-ADSC high dose
    Participants will receive 10x10\^6 RB-ADSC infused in the previously implanted Ommaya reservoir every 2 months for up to a total of 6 doses

Primary Outcome Measure

The safety of repeated RB-ADSC treatment in study participants with AD [ Time Frame: up to 12 months ]

Central Contacts

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