Back to search results

Autologous Activated Adipose-derived Stem Cells (RB-ADSC) for Alzheimer's Disease

This study is testing the safety of an investigational treatment called RB-ADSC for people with mild to moderate Alzheimer's disease. RB-ADSC uses stem cells taken from your own body fat (adipose tissue). These cells are grown in a lab and then put back into your brain through a small device called an Ommaya reservoir, which is placed under your scalp. Researchers want to see if this treatment is safe and to find the right dose for future studies. The study will also look at early signs of how well the treatment works. You might be able to join if you are between 45 and 80 years old, have mild to moderate Alzheimer's, and are otherwise in good health. The study aims to enroll 18 participants.

Study design
This is a Phase 1, open-label study, meaning you and the researchers will know what treatment you are receiving. It will enroll 18 participants in groups to test increasing doses of RB-ADSC.
What's involved
You would have a procedure to collect fat cells, another procedure to implant an Ommaya reservoir, and then receive injections of RB-ADSC. You will be followed for 12 months after treatment, with safety measured for up to 28 weeks.
Compensation
Not stated in the trial record.
Follow-up
Each participant will be followed for 12 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05667649

Autologous Activated Adipose-derived Stem Cells (RB-ADSC) Injected Directly Into the Brain for Mild to Moderate Alzheimer's Disease

Recruiting
PHASE1Ages 45–80InterventionalTreatment
Regeneration Biomedical, Inc.
~18 participants
Updated 2025-04-04 on ClinicalTrials.gov
What's tested:RB-ADSC

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The safety of RB-ADSC treatment in study participants with AD
Measured over up to 28 weeks

Conditions

Alzheimer Disease

Explore related trials

Alzheimer's Disease

Where it's being run

1 sites across 1 states
California1

Who to contact

Robert Lynn
[email protected]
877-240-1660
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

≥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

Exclusion

Taking other medications for AD, except that donepezil memantine, AChEIs including patches, Vitamin E, fish oil, and/or gingko biloba are allowed if doses have been stable for at least 3 months prior to the Screening visit
Stem cell implantation of any type within 3 months
Existing ventriculoperitoneal shunts
Neurological disorders except AD
Psychiatric disorders including schizophrenia, bipolar/unipolar depressive disorder, delirium
Drug or alcohol abuse or dependence within the past 5 years
Participants with a history of cancer in the past 5 years

What this trial measures

  • The safety of RB-ADSC treatment in study participants with ADup to 28 weeks

    Safety will be determined by incidence, type and severity of adverse events (AE) and serious adverse events (SAE) graded according to CTCAE v5.0 and CRS revised grading system and defined by clinical relevant findings at every visit and week 28 post-treatment in physical examination, vital signs and laboratory data