Repeat Intracerebroventricular Injections of RB-ADSC in Subjects Previously Treated in RBI Protocol RB-ADSC-02
Key facts
- Phase
- 1. fázis
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Regeneration Biomedical, Inc.
- Trial code
- NCT07373067
- Record updated
- 2026. augusztus 26.
- Original description
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.Read full original descriptionShow less
A Phase 1b Extension Trial To Allow Repeat Intracerebroventricular Injections of Ex Vivo Expanded, Autologous Adipose-Derived Stem Cells (RB-ADSCs) in Subjects Previously Treated in RBI Protocol RB-ADSC-02
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.
Inclusion: Successful completion of the Phase 1 single dose administration study of RB-ADSC, Protocol RB-ADSC-02; Written informed consent to participate in this Phase 1b Extension Study either provided by the participant or a legal representative; The participant must have a relative/caregiver who is alert for possible side effects; The caregiver must separately meet the specified inclusion/exclusion criteria for caregivers for this Phase 1b Extension Study.
Exclusion: Participant experienced treatment related SAE or DLT in Protocol RB-ADSC-02; Participants who, in the opinion of the Investigator, are unsuitable for this Phase 1 Extension Study.