Alzheimer DiseasePhase 1NCT07373067
Repeat Intracerebroventricular Injections of RB-ADSC in Subjects Previously Treated in RBI Protocol RB-ADSC-02
A Phase 1 study testing RB-ADSC in people with Alzheimer Disease, run by Regeneration Biomedical, Inc..
Trial summary
This is a Phase 1b Extension Trial to allow repeat intracerebroventricular injections of RB-ADSCs in subjects previously treated in and successfully completed RBI Protocol RB-ADSC-02. Read more about this study
- Who is it for?
- Ages 45 years and older
- 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
- 9 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Sep 2028
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Successful completion of the Phase 1 single dose administration study of RB-ADSC, Protocol RB-ADSC-02.
- Written informed consent to participate in this Phase 1b Extension Study either provided by the participant or a legal representative
- The participant must have a relative/caregiver who is alert for possible side effects.
- The caregiver must separately meet the specified inclusion/exclusion criteria for caregivers for this Phase 1b Extension Study.
Who cannot join
- Participant experienced treatment related SAE or DLT in Protocol RB-ADSC-02
- Participants who, in the opinion of the Investigator, are unsuitable for this Phase 1 Extension Study
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: A Phase 1b Extension Trial To Allow Repeat Intracerebroventricular Injections of Ex Vivo Expanded, Autologous Adipose-Derived Stem Cells (RB-ADSCs) in Subjects Previously Treated in RBI Protocol RB-ADSC-02
This is a Phase 1b Extension Trial to allow repeat intracerebroventricular injections of RB-ADSCs in subjects previously treated in and successfully completed RBI Protocol RB-ADSC-02. In the previous Phase 1 clinical trial, RB-ADSC-02, subjects with mild to moderate Alzheimer's disease (AD) received a single intraventricular injection of RB-ADSC. RB-ADSC will be delivered intracerebroventricularly every 2 months via the previously implanted Ommaya reservoir for up to 6 injections in total. The primary objective of safety is performed 2 months after the last dose administration at the month 12 follow-up visit. The secondary objective endpoint evaluations of efficacy are performed at the month 6 and 12 visits.
Read the detailed description
This is a Phase 1b Extension Trial to allow repeat intracerebroventricular injections of RB-ADSCs in subjects previously treated in and successfully completed RBI Protocol RB-ADSC-02. In the previous Phase 1 clinical trial, RB-ADSC-02, subjects with mild to moderate Alzheimer's disease (AD) received a single intraventricular injection of RB-ADSC.
RB-ADSC will be delivered intracerebroventricularly every 2 months via the previously implanted Ommaya reservoir for up to 6 injections in total. Participants will be followed for 2 months after the last administration. The primary objective is safety and tolerability of repeated dosing of RB-ADSC. Adverse events (AEs) and serious adverse events (SAEs) will be assessed by the incidence and severity of dose-limiting toxicity (DLT) and other AEs, incidence and severity of cytokine response syndrome, vital sign measurements, clinical laboratory tests and physical examination. Preliminary efficacy of repeated dosing will be evaluated with clinical assessments (MMSE, FAST, ADAS-Cog), volumetric MRI (NeuroQuant), CSF biomarkers (phosphor-Tau, total-Tau,AB-42), and diagnostic imaging comparison (Amyloid-PET).
- Conditions
- Alzheimer Disease
- Being tested
- RB-ADSC
- Keywords
- AD, Autologous, Stem cells, Cell therapy, Alzheimer Disease, RB-ADSC
- 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 2x10^6 RB-ADSC infused in the previously implanted Ommaya reservoir every 2 months for up to a total of 6 doses Receives: Biological: RB-ADSC |
| RB-ADSC medium dose | Experimental | Participants will receive 5x10^6 RB-ADSC infused in the previously implanted Ommaya reservoir every 2 months for up to a total of 6 doses Receives: Biological: RB-ADSC |
| RB-ADSC high dose | Experimental | Participants will receive 10x10^6 RB-ADSC infused in the previously implanted Ommaya reservoir every 2 months for up to a total of 6 doses Receives: Biological: RB-ADSC |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety of repeated 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 2 month following last dose in physical examination, vital signs and laboratory data
Measured: up to 12 months
Secondary outcomes (11)
Change from Baseline in cerebrospinal fluid (CSF) biomarker pTau
CSF Biomarkers will be measured with the ADmark® phospho-tau/total-tau/ Abeta-42 assay to determine the levels of Phosphorylated-Tau protein in the cerebrospinal fluid (CSF).
Measured: Baseline, Month 6, Month 12
Change from Baseline in cerebrospinal fluid (CSF) biomarker Total-Tau
CSF Biomarkers will be measured with the ADmark® phospho-tau/total-tau/ Abeta-42 assay to determine the levels of Total-Tau protein in the cerebrospinal fluid (CSF).
Measured: Baseline, Month 6, Month 12
Change from Baseline in cerebrospinal fluid (CSF) biomarker Ab42
CSF Biomarkers will be measured with the ADmark® phospho-tau/total-tau/ Abeta-42 assay to determine the levels of Ab42 in the cerebrospinal fluid (CSF).
Measured: Baseline, Month 6, Month 12
Change from Baseline in cerebrospinal fluid (CSF) biomarker ratios reported as amyloid-tau index (ATI)
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) to calculate ratios and report the amyloid-tau index (ATI).
Measured: Baseline, Month 6, 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, 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, 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, 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, Month 12
Change from Baseline in MoCA
Mild cognitive impairment and the early onset of dementia will be assessed using the Montreal Cognitive Assessment (MoCA)
Measured: Baseline, Month 6, 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 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
- NCT07373067
- Sponsor's protocol ID
- RB-ADSC-02E
- Status last verified
- Aug 2026
- First submitted
- 15 Jan 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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
- A Phase 1b Extension Trial To Allow Repeat Intracerebroventricular Injections of Ex Vivo Expanded, Autologous Adipose-Derived Stem Cells (RB-ADSCs) in Subjects Previously Treated in RBI Protocol RB-ADSC-02
- ClinicalTrials.gov ID
- NCT07373067
- Acronym / sponsor ID
- RB-ADSC-02E
- Conditions
- Alzheimer Disease
- Keywords
- AD, Autologous, Stem cells, Cell therapy, Alzheimer Disease, RB-ADSC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Regeneration Biomedical, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 28 Jan 2026 (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 Phase 1b Extension Trial to allow repeat intracerebroventricular injections of RB-ADSCs in subjects previously treated in and successfully completed RBI Protocol RB-ADSC-02. In the previous Phase 1 clinical trial, RB-ADSC-02, subjects with mild to moderate Alzheimer's disease (AD) received a single intraventricular injection of RB-ADSC. RB-ADSC will be delivered intracerebroventricularly every 2 months via the previously implanted Ommaya reservoir for up to 6 injections in total. The primary objective of safety is performed 2 months after the last dose administration at the month 12 follow-up visit. The secondary objective endpoint evaluations of efficacy are performed at the month 6 and 12 visits.
Detailed description
This is a Phase 1b Extension Trial to allow repeat intracerebroventricular injections of RB-ADSCs in subjects previously treated in and successfully completed RBI Protocol RB-ADSC-02. In the previous Phase 1 clinical trial, RB-ADSC-02, subjects with mild to moderate Alzheimer's disease (AD) received a single intraventricular injection of RB-ADSC.
RB-ADSC will be delivered intracerebroventricularly every 2 months via the previously implanted Ommaya reservoir for up to 6 injections in total. Participants will be followed for 2 months after the last administration. The primary objective is safety and tolerability of repeated dosing of RB-ADSC. Adverse events (AEs) and serious adverse events (SAEs) will be assessed by the incidence and severity of dose-limiting toxicity (DLT) and other AEs, incidence and severity of cytokine response syndrome, vital sign measurements, clinical laboratory tests and physical examination. Preliminary efficacy of repeated dosing will be evaluated with clinical assessments (MMSE, FAST, ADAS-Cog), volumetric MRI (NeuroQuant), CSF biomarkers (phosphor-Tau, total-Tau,AB-42), and diagnostic imaging comparison (Amyloid-PET).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RB-ADSC low dose | Experimental | Biological: RB-ADSCParticipants will receive 2x10^6 RB-ADSC infused in the previously implanted Ommaya reservoir every 2 months for up to a total of 6 doses |
| RB-ADSC medium dose | Experimental | Biological: RB-ADSCParticipants will receive 5x10^6 RB-ADSC infused in the previously implanted Ommaya reservoir every 2 months for up to a total of 6 doses |
| RB-ADSC high dose | Experimental | Biological: RB-ADSCParticipants will receive 10x10^6 RB-ADSC infused in the previously implanted Ommaya reservoir every 2 months for up to a total of 6 doses |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Successful completion of the Phase 1 single dose administration study of RB-ADSC, Protocol RB-ADSC-02.
- Written informed consent to participate in this Phase 1b Extension Study either provided by the participant or a legal representative
- The participant must have a relative/caregiver who is alert for possible side effects.
- The caregiver must separately meet the specified inclusion/exclusion criteria for caregivers for this Phase 1b Extension Study.
Key exclusion criteria (2 listed)
- Participant experienced treatment related SAE or DLT in Protocol RB-ADSC-02
- Participants who, in the opinion of the Investigator, are unsuitable for this Phase 1 Extension Study
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 repeated RB-ADSC treatment in study participants with AD
Time frame: up to 12 months
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 2 month following last dose in physical examination, vital signs and laboratory data
11 secondary outcomes
Change from Baseline in cerebrospinal fluid (CSF) biomarker pTau
Time frame: Baseline, Month 6, Month 12
Change from Baseline in cerebrospinal fluid (CSF) biomarker Total-Tau
Time frame: Baseline, Month 6, Month 12
Change from Baseline in cerebrospinal fluid (CSF) biomarker Ab42
Time frame: Baseline, Month 6, Month 12
Change from Baseline in cerebrospinal fluid (CSF) biomarker ratios reported as amyloid-tau index (ATI)
Time frame: Baseline, Month 6, Month 12
Change from Baseline in Amyloid Positron Emission Tomography (Amyloid-PET)
Time frame: Baseline, Month 6, Month 12
Change from Baseline in MMSE
Time frame: Baseline, Month 6, Month 12
Change from Baseline in ADAS-cog13
Time frame: Baseline, Month 6, Month 12
Change from Baseline in FAST
Time frame: Baseline, Month 6, Month 12
Change from Baseline in MoCA
Time frame: Baseline, Month 6, 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
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: 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.
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..
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 4 inclusion and 2 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. 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?
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?
The safety of repeated RB-ADSC treatment in study participants with AD (time frame: up to 12 months). 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.