Ph 1, Open-Label Safety Study of Escalating Doses of Intracerebroventricular Injections of Ex Vivo Expanded, Autologous ADSCs in Participants With Mild-Moderate AD Whose Treatment is Not Addressed Adequately by Available Therapy
Regeneration Biomedical, Inc.
Summary
This is a research study to evaluate the safety of an investigational autologous cell product obtained from participant's own adipose tissue as a possible treatment for Alzheimer disease.
Description
This is a Phase 1, Open-Label Safety Study of Escalating Doses of Intracerebroventricular Injections of Ex Vivo Expanded, Autologous Adipose-Derived Stem Cells (ADSCs) in Participants with Mild to Moderate Alzheimer's Disease (AD) whose Treatment is not Addressed Adequately by Available Therapy (i.e., an unmet medical need). The investigational product, which is referred to as RB-ADSC, consists of stem cells obtained from the participant's own adipose tissue by lipoaspirate. After collection, the stem cells are cultured and expanded outside the body, and then reintroduced into the same patient…
Eligibility
- Age range
- 45–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * ≥45 and ≤80 years of age * Mild to moderate AD diagnosis * Adequate cognitive function * Non-remarkable clinical laboratory * Ability to voluntarily provide written informed consent * No tumors or other disease responsible for dementia * Well-controlled comorbidities, on stable medications for 3 months * The participant is otherwise in good general health * The participant must have a relative/caregiver * Participant must be able to donate adequate amount of lipoaspirate to establish the final product * Caregiver separately meets the specified inclusion/exclusion criteri…
Interventions
- BiologicalRB-ADSC
Ex Vivo Expanded, Autologous Adipose-Derived Stem Cells (ADSCs)
Location
- Hoag Memorial Hospital PresbyterianNewport Beach, California