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

Official Summary

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.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NON_RANDOMIZED
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 9 participants

Interventions

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

Primary Outcomes

• The safety of repeated RB-ADSC treatment in study participants with AD (up to 12 months)

Secondary Outcomes

• Change from Baseline in cerebrospinal fluid (CSF) biomarker pTau (Baseline, Month 6, Month 12)
• Change from Baseline in cerebrospinal fluid (CSF) biomarker Total-Tau (Baseline, Month 6, Month 12)
• Change from Baseline in cerebrospinal fluid (CSF) biomarker Ab42 (Baseline, Month 6, Month 12)
• Change from Baseline in cerebrospinal fluid (CSF) biomarker ratios reported as amyloid-tau index (ATI) (Baseline, Month 6, Month 12)
• Change from Baseline in Amyloid Positron Emission Tomography (Amyloid-PET) (Baseline, Month 6, Month 12)

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