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

Not Yet RecruitingPhase 1

Sponsor: Regeneration Biomedical, Inc.

Conditions: Alzheimer Disease

Interventions: RB-ADSC

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.

Eligibility overview

Sex: ALL

Age: 45 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Successful completion of the Phase 1 single dose administration study of RB-ADSC, Protocol RB-ADSC-02.
2. Written informed consent to participate in this Phase 1b Extension Study either provided by the participant or a legal representative
3. The participant must have a relative/caregiver who is alert for possible side effects.
4. The caregiver must separately meet the specified inclusion/exclusion criteria for caregivers for this Phase 1b Extension Study.

Exclusion Criteria:

1. Participant experienced treatment related SAE or DLT in Protocol RB-ADSC-02
2. Participants who, in the opinion of the Investigator, are unsuitable for this Phase 1 Extension Study