Alzheimer DiseasePhase 1NCT05667649
Autologous Activated Adipose-derived Stem Cells (RB-ADSC) Injected Directly Into the Brain for Mild to Moderate Alzheimer's Disease
A Phase 1 study testing RB-ADSC in people with Alzheimer Disease, run by Regeneration Biomedical, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- RB-ADSC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2023to 25 Jun 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
About this study
Official title: 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
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.
Read the detailed 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. A soft plastic reservoir (Ommaya reservoir) is implanted under the scalp, communicating with the brain cavities (ventricles). This study will primarily evaluate the safety of RB-ADSC injected in the Ommaya reservoir in a 3 + 3 dose escalation study. The planned enrollment will be 9 participants, 3 participants per escalation Cohort.
The primary objectives will evaluate adverse events, serious adverse events, and dose limiting toxicities to determine a recommended phase 2 clinical trial dose. Secondary objectives will evaluate preliminary efficacy measured by clinical assessments, volumetric MRI (Neuro Quant®), CSF biomarkers (Phospho-Tau, Total Tau, AB-42), and diagnostic imaging comparison (Amyloid PET). Each participant will be followed for 12 months after treatment.
- Conditions
- Alzheimer Disease
- Being tested
- RB-ADSC
- Keywords
- Alzheimer's Disease, AD, Autologous, Stem cells
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RB-ADSCBiological
Ex Vivo Expanded, Autologous Adipose-Derived Stem Cells (ADSCs)
| Study group | Role | What they receive |
|---|---|---|
| RB-ADSC low dose | Experimental | Participants will receive one dose of 2x10^6 RB-ADSC infused in the previously implanted Ommaya reservoir Receives: Biological: RB-ADSC |
| RB-ADSC medium dose | Experimental | Participants will receive one dose of 5x10^6 RB-ADSC infused in the previously implanted Ommaya reservoir Receives: Biological: RB-ADSC |
| RB-ADSC high dose | Experimental | Participants will receive one dose of 10x10^6 RB-ADSC infused in the previously implanted Ommaya reservoir Receives: Biological: RB-ADSC |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety of RB-ADSC treatment in study participants with AD
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
Measured: up to 28 weeks
Secondary outcomes (2)
Change from Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog)
Measured by the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) is a cognitive performance test. The ADAS-cog score ranges from 0 to 70, with higher scores indicating greater cognitive impairment (higher score is worse outcome).
Measured: up to 52 weeks
Change from Baseline in Mini Mental State Examination (MMSE)
Measured by the Mini Mental State Examination (MMSE). MMSE is a performance-based test of global cognitive status.. The MMSE score ranges from 0 to 30, with lower scores indicating greater cognitive impairment (lower score is worse outcome).
Measured: up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start14 Aug 2023
- Primary completion25 Jun 2026
- Study completion25 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneration Biomedical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05667649
- Sponsor's protocol ID
- RB-ADSC-02
- Status last verified
- Sep 2026
- First submitted
- 1 Dec 2022
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Duma C, Kopyov O, Kopyov A, Berman M, Lander E, Elam M, Arata M, Weiland D, Cannell R, Caraway C, Berman S, Scord K, Stemler L, Chung K, Khoudari S, McRory R, Duma C, Farmer S, Bravo A, Yassa C, Sanathara A, Singh E, Rapaport B. Human intracerebroventricular (ICV) injection of autologous, non-engineered, adipose-derived stromal vascular fraction (ADSVF) for neurodegenerative disorders: results of a 3-year phase 1 study of 113 injections in 31 patients. Mol Biol Rep. 2019 Oct;46(5):5257-5272. doi: 10.1007/s11033-019-04983-5. Epub 2019 Jul 20.
PubMed 31327120
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05667649
- Acronym / sponsor ID
- RB-ADSC-02
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer's Disease, AD, Autologous, Stem cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Regeneration Biomedical, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Aug 2023 (actual)
- Primary completion
- 25 Jun 2026 (actual)
- Study completion
- 25 Jun 2026 (actual)
- First posted
- 28 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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. A soft plastic reservoir (Ommaya reservoir) is implanted under the scalp, communicating with the brain cavities (ventricles). This study will primarily evaluate the safety of RB-ADSC injected in the Ommaya reservoir in a 3 + 3 dose escalation study. The planned enrollment will be 9 participants, 3 participants per escalation Cohort.
The primary objectives will evaluate adverse events, serious adverse events, and dose limiting toxicities to determine a recommended phase 2 clinical trial dose. Secondary objectives will evaluate preliminary efficacy measured by clinical assessments, volumetric MRI (Neuro Quant®), CSF biomarkers (Phospho-Tau, Total Tau, AB-42), and diagnostic imaging comparison (Amyloid PET). Each participant will be followed for 12 months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RB-ADSC low dose | Experimental | Biological: RB-ADSCParticipants will receive one dose of 2x10^6 RB-ADSC infused in the previously implanted Ommaya reservoir |
| RB-ADSC medium dose | Experimental | Biological: RB-ADSCParticipants will receive one dose of 5x10^6 RB-ADSC infused in the previously implanted Ommaya reservoir |
| RB-ADSC high dose | Experimental | Biological: RB-ADSCParticipants will receive one dose of 10x10^6 RB-ADSC infused in the previously implanted Ommaya reservoir |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- ≥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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RB-ADSCEx Vivo Expanded, Autologous Adipose-Derived Stem Cells (ADSCs) | Biological | RB-ADSC high dose, RB-ADSC low dose, RB-ADSC medium dose |
Primary outcome
The safety of RB-ADSC treatment in study participants with AD
Time frame: up 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
2 secondary outcomes
Change from Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog)
Time frame: up to 52 weeks
Change from Baseline in Mini Mental State Examination (MMSE)
Time frame: up to 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Background: PubMed 31327120Duma C, Kopyov O, Kopyov A, Berman M, Lander E, Elam M, Arata M, Weiland D, Cannell R, Caraway C, Berman S, Scord K, Stemler L, Chung K, Khoudari S, McRory R, Duma C, Farmer S, Bravo A, Yassa C, Sanathara A, Singh E, Rapaport B. Human intracerebroventricular (ICV) injection of autologous, non-engineered, adipose-derived stromal vascular fraction (ADSVF) for neurodegenerative disorders: results of a 3-year phase 1 study of 113 injections in 31 patients. Mol Biol Rep. 2019 Oct;46(5):5257-5272. doi: 10.1007/s11033-019-04983-5. Epub 2019 Jul 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RB-ADSC in people with Alzheimer Disease, run by Regeneration Biomedical, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety of RB-ADSC treatment in study participants with AD (time frame: up to 28 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05667649, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.