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Fat cells to the brain: a new Alzheimer's experiment

NCT ID NCT05667649

Disease control Sponsor: Regeneration Biomedical, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 24, 2026 · Last updated Sep 25, 2026 · Updated 1 time

Summary

Researchers are testing whether injecting a person's own fat-derived stem cells into the brain's fluid-filled spaces is safe for people with mild to moderate Alzheimer's disease. The study enrolls a small number of adults aged 45 to 80 who have not responded well to available treatments. Participants undergo a minor liposuction to collect fat tissue, which scientists grow into stem cells and then inject back into the brain. The main goal is to track side effects and safety over 28 weeks, while also watching for any changes in memory and thinking.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
autologous adipose-derived stem cells (RB-ADSC) injected into the brain's fluid-filled spaces
What this could lead to
If it proves safe, this approach could open the door to larger trials testing whether a person's own fat-derived stem cells can slow or ease Alzheimer's symptoms.
What could go wrong
This is a very small, early-stage safety study with only a handful of participants, so it cannot show whether the treatment works. Brain injections carry risks such as bleeding, infection, or immune reactions, and the cells may not survive or help.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

7 people

The number who actually took part.

Started

Aug 2023

Finished

Jun 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 criteria for caregivers Exclusion Criteria: * 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 * No caregiver available to meet the inclusion criteria for caregivers

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Conditions

The condition(s) this trial relates to.

Alzheimer disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alzheimer disease

Contacts and locations

Locations

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663, United States

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