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Sponsor: Regeneration Biomedical, Inc.
Conditions: Alzheimer Disease
Interventions: RB-ADSC, Placebo
The goal of this Phase 2 clinical trial is to learn if repeated dosing of RB-ADSC (an investigational autologous cell product obtained from participant's own adipose tissue) enhances the positive preliminary results seen in Phase 1 for the of treatment for mild to moderate Alzheimer's Disease in adults. The clinical trial will also continue to evaluate the safety of repeated dosing of RB-ADSC. This study will primarily evaluate the effects of repeated dosing of RB-ADSC on cognitive performance compared to placebo control. Participants will receive RB-ADSC every 2 months for a total of 6 doses. Participants randomized into the placebo control group will have the option to cross over to receive treatment after completion of the primary phase of the study.
Sex: ALL
Age: 45 Years to 85 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * ≥45 and ≤85 years of age * Mild to moderate AD diagnosis * FAST stage 4 or 5 * MMSE 10-23 * Amyloid PET scan centiloid score \>30 * ADmark® CSF analysis of ATI (\<1.0) and P-Tau (\>60) * No tumors or other disease responsible for dementia * Participant otherwise in good general health * Written informed consent from participant or legal representative * Participant must have caregiver who separately meets specified inclusion/exclusion criteria for caregivers * Participant must be able to donate adequate amount of lipoaspirate to establish the final product Exclusion Criteria: * Taking prohibited medications * Prior cell therapy implantation * Existing ventriculoperitoneal shunts * Neurological disorders except AD * Psychiatric disorders such as schizophrenia, bipolar/unipolar depression, delirium * Drug or alcohol abuse in past 2 years * History of cancer within the past 5 years * No caregiver available to meet the inclusion criteria for caregivers * Involvement in other investigational product clinical trial within the past 3 months for monoclonal antibodies, or 6 months for other investigational products