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NCT Number: NCT07373067

Repeat Intracerebroventricular Injections of RB-ADSC 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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

RB-ADSC

Biological

Ex Vivo Expanded, Autologous Adipose-Derived Stem Cells (ADSCs)

Primary outcomes

  1. 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

Secondary outcomes

  1. Change from Baseline in cerebrospinal fluid (CSF) biomarker pTau

    Time frame: Baseline, Month 6, Month 12

    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).

  2. Change from Baseline in cerebrospinal fluid (CSF) biomarker Total-Tau

    Time frame: Baseline, Month 6, Month 12

    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).

  3. Change from Baseline in cerebrospinal fluid (CSF) biomarker Ab42

    Time frame: Baseline, Month 6, Month 12

    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).

  4. Change from Baseline in cerebrospinal fluid (CSF) biomarker ratios reported as amyloid-tau index (ATI)

    Time frame: Baseline, Month 6, Month 12

    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).

  5. Change from Baseline in Amyloid Positron Emission Tomography (Amyloid-PET)

    Time frame: Baseline, Month 6, Month 12

    Amyloid-PET will be used to quantitatively assess amyloid plaque deposition in the brain

  6. Change from Baseline in MMSE

    Time frame: Baseline, Month 6, Month 12

    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.

  7. Change from Baseline in ADAS-cog13

    Time frame: Baseline, Month 6, Month 12

    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.

  8. Change from Baseline in FAST

    Time frame: Baseline, Month 6, Month 12

    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.

  9. Change from Baseline in MoCA

    Time frame: Baseline, Month 6, Month 12

    Mild cognitive impairment and the early onset of dementia will be assessed using the Montreal Cognitive Assessment (MoCA)

  10. Change from Baseline in Volumetric MRI with Contrast

    Time frame: Baseline, Month 6 and Month 12

    Volumetric MRI with contrast of the brain will be used to detect and monitor brain abnormalities.

  11. Change from Baseline in NeuroQuant MRI

    Time frame: Baseline, Month 6 and Month 12

    NeuroQuant MRI will be used to measure volumes of brain structures.

Study contacts

Contact information is provided by the study sponsor or research team.

Robert Lynn

CONTACT

[email protected]

877-240-1660

Sponsors and collaborators

Lead sponsor

Regeneration Biomedical, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 28, 2026
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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