Neurosciences Clinical Trials
Repeat Intracerebroventricular Injections of RB-ADSC in Subjects Previously Treated in RBI Protocol RB-ADSC-02
Learn moreWhat is the purpose of this study?
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
- 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/
for caregivers for this Phase 1b Extension Study.
Exclusion Criteria:
- 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
Where can I participate?
Hoag Hospital Newport Beach
1 Hoag
Newport Beach, CA 92663
What is the full name of this Clinical Trial?
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
- Disease Type/ConditionAlzheimer Disease
- Principal InvestigatorGustavo Alva, MD
- Co-InvestigatorsRobert Louis, MD
- Age GroupAdult, Older Adult
- PhaseI
- ClinicalTrials.gov IDNCT07373067
- Key Eligibilityclinicaltrials.gov
- How do I learn more about this study?Laurie Hendricks
laurie.hendricks@hoag.org
Pickup Family Neurosciences Institute
https://www.hoag.org/institute/neurosciences/
Hoag’s Pickup Family Neurosciences Institute offers Orange County’s most comprehensive neurologic care, with multidisciplinary specialists, advanced technology, and evidence-based treatment for complex brain, spine, and nervous system conditions. Patients have access to leading programs in brain tumors, memory and cognitive disorders, multiple sclerosis, epilepsy, Parkinson’s and movement disorders, headache and migraine, stroke, and clinical trials.
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