Alzheimer DiseasePhase 2NCT07205601
Study of Intracerebroventricular Injections of Autologous Adipose-Derived Stem Cells (RB-ADSCs) in Participants With Mild-Moderate Alzheimer's Disease
A Phase 2 study testing RB-ADSC in people with Alzheimer Disease, run by Regeneration Biomedical, Inc..
Trial summary
The goal of this Phase 2 clinical trial is to learn if repeated dosing of RB-ADSC (an investigational autologous cell product obtained from participant's own adipose tissue) enhances the positive preliminary results seen in Phase 1 for the of treatment for mild to moderate Alzheimer's Disease in adults. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- RB-ADSC
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Feb 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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)
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Phase 2a Assessment of Safety, Tolerability, and Efficacy of Repeated Dosing of Intracerebroventricular Injections of Ex Vivo Expanded, Autologous Adipose-Derived Stem Cells (RB-ADSCs) in Participants With Mild to Moderate Alzheimer's Disease
The goal of this Phase 2 clinical trial is to learn if repeated dosing of RB-ADSC (an investigational autologous cell product obtained from participant's own adipose tissue) enhances the positive preliminary results seen in Phase 1 for the of treatment for mild to moderate Alzheimer's Disease in adults. The clinical trial will also continue to evaluate the safety of repeated dosing of RB-ADSC. This study will primarily evaluate the effects of repeated dosing of RB-ADSC on cognitive performance compared to placebo control. Participants will receive RB-ADSC every 2 months for a total of 6 doses. Participants randomized into the placebo control group will have the option to cross over to receive treatment after completion of the primary phase of the study.
Read the detailed description
This is a randomized, placebo-controlled, dose range finding for safety and efficacy, Phase 2a U.S. multicenter study of repeated administration of RB-ADSC in participants with mild to moderate Alzheimer's Disease AD. RB ADSC consists of stem cells obtained from the participant's own adipose tissue by lipoaspirate that have been cultured and expanded outside the body, enriched for Wnt-activated cells, and prepared for administration into the same participant. An Ommaya reservoir, which is an intraventricular catheter system, will be implanted under the scalp for intraventricular administration of RB-ADSC.
Approximately 115 adult participants are expected to be enrolled in this Phase 2a study. Participants will be randomized at a 4:1 ratio of RB-ADSC treatment to placebo. Participants randomized into the RB-ADSC treatment arm will be subsequently randomized with a 1:1 ratio to a treatment dose level: low-dose RB-ADSC (2.5 x 10^6 cells), and high-dose RB-ADSC (5.0 x 10^6 cells), for an overall randomization scheme of 2:2:1.
RB-ADSC will be delivered intracerebroventricularly every 2 months via the previously implanted Ommaya reservoir for a treatment duration of 10 months (inclusive of 10th month; up to 6 injections in total). Participants will be followed for 6 months after the last administration. The primary and secondary objectives will evaluate the efficacy based on cognitive, functional and CSF biomarker (Phospho-Tau, Total Tau, AB-42) assessments. Additionally, safety evaluations, volumetric MRI (Neuro Quant®) assessment, and diagnostic imaging comparison (Amyloid PET) will be performed.
After completing the Month 12 evaluation, participants in the placebo arm will be allowed to cross over to receive RB-ADSC. Participants in the cross-over will be randomized to a treatment dose level (low dose or high dose) at a 1:1 ratio. Cross-over participants will receive RB-ADSC doses every 2 months for a treatment duration of 10 months.
- Conditions
- Alzheimer Disease
- Being tested
- RB-ADSC, Placebo
- Keywords
- AD, Autologous, Stem cells, Cell therapy, Alzheimer Disease
- 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
RB-ADSC is an investigational an ex-vivo expanded autologous adipose-derived stem cell product
PlaceboOther
0.9% NaCl USP
| Study group | Role | What they receive |
|---|---|---|
| RB-ADSC low dose | Experimental | Participants will receive repeated doses of 2.5x10^6 RB-ADSC infused in the previously implanted Ommaya reservoir Receives: Biological: RB-ADSC |
| RB-ADSC high dose | Experimental | Participants will receive repeated doses of 5x10^6 RB-ADSC infused in the previously implanted Ommaya reservoir Receives: Biological: RB-ADSC |
| Placebo control | Placebo comparator | Participants will receive placebo comparator in the previously implanted Ommaya reservoir Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Composite Score
iADRS will be used to assess whether RB-ADSC slows down the clinical decline associated with AD compared with placebo. iADRS evaluates cognition and daily function performance by combining items from the ADAS-Cog13 and the Alzheimer's disease cooperative study-instrumental activities of daily living scale (ADCS-iADL). The scale ranges from 0 to 144, where lower scores indicate worse performance and higher score indicates better performance.
Measured: Baseline, Month 6 and Month 12
Secondary outcomes (10)
Change from Baseline in CSF Biomarkers
CSF Biomarkers will be measured with the ADmark® phospho-tau/total-tau/ Abeta-42 assay to determine the levels of Phosphorylated-Tau protein, Total-Tau protein, and Ab42 in the cerebrospinal fluid (CSF). The amyloid-tau index (ATI) will also be determined.
Measured: Baseline, Month 6 and Month 12
Change from Baseline in MMSE
Cognitive function will be evaluated with the Mini Mental State Examination (MMSE). The range for the total MMSE score is 0 to 30, with lower scores indicating greater level of impairment.
Measured: Baseline, Month 6 and Month 12
Change from Baseline in ADAS-cog13
Cognitive function will be assessed using the AD Assessment Scale - Cognitive (ADAS-cog13). The ADAS-Cog13 scale ranges from 0 to 85, with higher scores indicating greater disease severity.
Measured: Baseline, Month 6 and Month 12
Change from Baseline in FAST
Functional abilities will be assessed using the Functional Assessment Staging Tool (FAST). The tool consists of seven stages, with higher scores indicating more severe impairment.
Measured: Baseline, Month 6 and Month 12
Change from Baseline in ADCS-iADL
Functional ability will be assessed using the AD Cooperative Study-Activities of Daily Living Scale (ADCS-ADL). The iADL score ranges from 0 to 59, with lower scores indicating greater impairment.
Measured: Baseline, Month 6 and Month 12
Change from Baseline in CDR-SB
Cognitive changes will be assessed with the Clinical Dementia Rating - Sum of Boxes (CDR-SB). Scores range from 0 to 18 with higher scores indicative of more impairment.
Measured: Baseline, Month 6 and Month 12
Change from Baseline in Amyloid Positron Emission Tomography (Amyloid-PET)
Amyloid-PET will be used to quantitatively assess amyloid plaque deposition in the brain
Measured: Baseline, Month 6 and Month 12
Change from Baseline in Volumetric MRI with Contrast
Volumetric MRI with contrast of the brain will be used to detect and monitor brain abnormalities.
Measured: Baseline, Month 6 and Month 12
Change from Baseline in NeuroQuant MRI
NeuroQuant MRI will be used to measure volumes of brain structures.
Measured: Baseline, Month 6 and Month 12
Safety of Repeated Dosing RB-ADSC
Safety will be determined by the number of treatment-related adverse events (AE) and serious adverse events (SAE) graded according to CTCAE v5.0 up to Month 16 compared to placebo control
Measured: Up to Month 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study startOct 2026 (estimated)
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regeneration Biomedical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07205601
- Sponsor's protocol ID
- RB-ADSC-03
- Status last verified
- Aug 2026
- First submitted
- 17 Sep 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2a Assessment of Safety, Tolerability, and Efficacy of Repeated Dosing of Intracerebroventricular Injections of Ex Vivo Expanded, Autologous Adipose-Derived Stem Cells (RB-ADSCs) in Participants With Mild to Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT07205601
- Acronym / sponsor ID
- RB-ADSC-03
- Conditions
- Alzheimer Disease
- Keywords
- AD, Autologous, Stem cells, Cell therapy, Alzheimer Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Regeneration Biomedical, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 3 Oct 2025 (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.
The goal of this Phase 2 clinical trial is to learn if repeated dosing of RB-ADSC (an investigational autologous cell product obtained from participant's own adipose tissue) enhances the positive preliminary results seen in Phase 1 for the of treatment for mild to moderate Alzheimer's Disease in adults. The clinical trial will also continue to evaluate the safety of repeated dosing of RB-ADSC. This study will primarily evaluate the effects of repeated dosing of RB-ADSC on cognitive performance compared to placebo control. Participants will receive RB-ADSC every 2 months for a total of 6 doses. Participants randomized into the placebo control group will have the option to cross over to receive treatment after completion of the primary phase of the study.
Detailed description
This is a randomized, placebo-controlled, dose range finding for safety and efficacy, Phase 2a U.S. multicenter study of repeated administration of RB-ADSC in participants with mild to moderate Alzheimer's Disease AD. RB ADSC consists of stem cells obtained from the participant's own adipose tissue by lipoaspirate that have been cultured and expanded outside the body, enriched for Wnt-activated cells, and prepared for administration into the same participant. An Ommaya reservoir, which is an intraventricular catheter system, will be implanted under the scalp for intraventricular administration of RB-ADSC.
Approximately 115 adult participants are expected to be enrolled in this Phase 2a study. Participants will be randomized at a 4:1 ratio of RB-ADSC treatment to placebo. Participants randomized into the RB-ADSC treatment arm will be subsequently randomized with a 1:1 ratio to a treatment dose level: low-dose RB-ADSC (2.5 x 10^6 cells), and high-dose RB-ADSC (5.0 x 10^6 cells), for an overall randomization scheme of 2:2:1.
RB-ADSC will be delivered intracerebroventricularly every 2 months via the previously implanted Ommaya reservoir for a treatment duration of 10 months (inclusive of 10th month; up to 6 injections in total). Participants will be followed for 6 months after the last administration. The primary and secondary objectives will evaluate the efficacy based on cognitive, functional and CSF biomarker (Phospho-Tau, Total Tau, AB-42) assessments. Additionally, safety evaluations, volumetric MRI (Neuro Quant®) assessment, and diagnostic imaging comparison (Amyloid PET) will be performed.
After completing the Month 12 evaluation, participants in the placebo arm will be allowed to cross over to receive RB-ADSC. Participants in the cross-over will be randomized to a treatment dose level (low dose or high dose) at a 1:1 ratio. Cross-over participants will receive RB-ADSC doses every 2 months for a treatment duration of 10 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RB-ADSC low dose | Experimental | Biological: RB-ADSCParticipants will receive repeated doses of 2.5x10^6 RB-ADSC infused in the previously implanted Ommaya reservoir |
| RB-ADSC high dose | Experimental | Biological: RB-ADSCParticipants will receive repeated doses of 5x10^6 RB-ADSC infused in the previously implanted Ommaya reservoir |
| Placebo control | Placebo comparator | Other: PlaceboParticipants will receive placebo comparator in the previously implanted Ommaya reservoir |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- ≥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
Key exclusion criteria (9 listed)
- Taking prohibited medications
- Prior cell therapy implantation
- Existing ventriculoperitoneal shunts
- Neurological disorders except AD
- Psychiatric disorders such as schizophrenia, bipolar/unipolar depression, 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-ADSCRB-ADSC is an investigational an ex-vivo expanded autologous adipose-derived stem cell product | Biological | RB-ADSC high dose, RB-ADSC low dose |
| Placebo0.9% NaCl USP | Other | Placebo control |
Primary outcome
Change from Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Composite Score
Time frame: Baseline, Month 6 and Month 12
iADRS will be used to assess whether RB-ADSC slows down the clinical decline associated with AD compared with placebo. iADRS evaluates cognition and daily function performance by combining items from the ADAS-Cog13 and the Alzheimer's disease cooperative study-instrumental activities of daily living scale (ADCS-iADL). The scale ranges from 0 to 144, where lower scores indicate worse performance and higher score indicates better performance.
10 secondary outcomes
Change from Baseline in CSF Biomarkers
Time frame: Baseline, Month 6 and Month 12
Change from Baseline in MMSE
Time frame: Baseline, Month 6 and Month 12
Change from Baseline in ADAS-cog13
Time frame: Baseline, Month 6 and Month 12
Change from Baseline in FAST
Time frame: Baseline, Month 6 and Month 12
Change from Baseline in ADCS-iADL
Time frame: Baseline, Month 6 and Month 12
Change from Baseline in CDR-SB
Time frame: Baseline, Month 6 and Month 12
Change from Baseline in Amyloid Positron Emission Tomography (Amyloid-PET)
Time frame: Baseline, Month 6 and Month 12
Change from Baseline in Volumetric MRI with Contrast
Time frame: Baseline, Month 6 and Month 12
Change from Baseline in NeuroQuant MRI
Time frame: Baseline, Month 6 and Month 12
Safety of Repeated Dosing RB-ADSC
Time frame: Up to Month 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RB-ADSC in people with Alzheimer Disease, run by Regeneration Biomedical, Inc..
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 9 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: opening soon, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert Lynn (877-240-1660, robert@regenerationbiomedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Composite Score (time frame: Baseline, Month 6 and Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2026.