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Could your own fat cells fight Alzheimer's? new trial aims to find out

NCT ID NCT07205601

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Aug 27, 2026 · Updated 3 times

Summary

This Phase 2 trial tests whether repeated injections of a patient's own fat-derived stem cells into the brain can slow the progression of mild to moderate Alzheimer's disease. 115 participants will receive either the stem cells or a placebo every two months for a total of six doses. The main goal is to see if the treatment preserves memory and daily living skills better than placebo.

What this could mean

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

Active substance
patient's own fat-derived stem cells (RB-ADSC)
What this could lead to
If it works, this could slow memory loss and daily function decline in people with mild to moderate Alzheimer's disease.
What could go wrong
This is an early Phase 2 trial with only 115 participants. The treatment involves injections into the brain, which carries risks like infection or bleeding. Previous positive results were from a smaller Phase 1 study and may not hold up.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 115 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Feb 2030

An estimate. End dates often move.

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 85 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 ≤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

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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

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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