NCT07373067

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1 alzheimer-disease

Timeline
19mo left

Started Jan 2026

Typical duration for phase_1 alzheimer-disease

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Jan 2026Jan 2028

Study Start

First participant enrolled

January 1, 2026

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 28, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

January 15, 2026

Last Update Submit

January 22, 2026

Conditions

Alzheimer Disease

Keywords

ADAutologousStem cellsCell therapyAlzheimer DiseaseRB-ADSC

Outcome Measures

Primary Outcomes (1)

  • 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

    up to 12 months

Secondary Outcomes (11)

  • Change from Baseline in cerebrospinal fluid (CSF) biomarker pTau

    Baseline, Month 6, Month 12

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

    Baseline, Month 6, Month 12

  • Change from Baseline in cerebrospinal fluid (CSF) biomarker Ab42

    Baseline, Month 6, Month 12

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

    Baseline, Month 6, Month 12

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

    Baseline, Month 6, Month 12

  • +6 more secondary outcomes

Study Arms (3)

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

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

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

Biological: RB-ADSC

Interventions

RB-ADSCBIOLOGICAL

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

RB-ADSC high doseRB-ADSC low doseRB-ADSC medium dose

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Central Study Contacts

Robert Lynn

CONTACT

877-240-1660robert@regenerationbiomedical.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2026

First Posted

January 28, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Last Updated

January 28, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share