Stem Cell Injections for Mild to Moderate Alzheimer's Disease
RB-ADSC
+ Placebo
Alzheimer Disease+6
+ Mental Disorders
+ Brain Diseases
Treatment Study
Summary
Study start date: November 1, 2025
Actual date on which the first participant was enrolled.This clinical trial is exploring a new treatment approach for individuals with mild to moderate Alzheimer's disease, using stem cells derived from the patient's own body fat. These stem cells, called RB-ADSCs, are expanded and prepared outside the body to activate certain helpful cells. The study aims to determine if this treatment is safe, well-tolerated, and effective in slowing down or improving symptoms of Alzheimer's disease. Alzheimer's disease is a progressive condition that affects memory and thinking skills, and finding innovative treatments is crucial to improve the quality of life for those affected. Participants in the study will receive these stem cells through a device implanted under the scalp, called an Ommaya reservoir, which allows the cells to be delivered directly to the brain. The treatment occurs every two months over a period of 10 months, with a total of up to six injections. Researchers will evaluate the impact of the treatment on cognitive functions and specific markers in the brain fluid. Safety is also closely monitored using brain scans and imaging techniques. After the initial study period, those who received a placebo may switch to receive the stem cell treatment. This study's findings could provide valuable insights into the potential benefits and risks of using stem cells to treat Alzheimer's disease.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.115 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 45 to 85 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
33.333% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives