NCT07373067Not yet recruitingPhase 1
Repeat Intracerebroventricular Injections of RB-ADSC in Subjects Previously Treated in RBI Protocol RB-ADSC-02
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
Source: ClinicalTrials.gov · Last updated 26 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 9 (estimated)
- First submitted
- 15 Jan 2026
- Start date
- Sept 2026
- Primary completion date
- Sept 2028
- Lead sponsor
- Regeneration Biomedical, Inc.
- Diseases
- Alzheimer disease
- NCT number
- NCT07373067
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 9
- From Sept 2026 to the primary completion date, Sept 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 45 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.