Study of Intracerebroventricular Injections of Autologous Adipose-Derived Stem Cells (RB-ADSCs) in Participants With Mild-Moderate Alzheimer's Disease

NCT07205601 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: RB-ADSC-03
• Study Type: interventional
• Target: 115
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Alzheimer Disease

Keywords

AD; Autologous; Stem cells; Cell therapy; Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Month 6 and Month 12

Secondary Outcomes (10)

• Change from Baseline in CSF Biomarkers

  Baseline, Month 6 and Month 12

• Change from Baseline in MMSE

  Baseline, Month 6 and Month 12

• Change from Baseline in ADAS-cog13

  Baseline, Month 6 and Month 12

• Change from Baseline in FAST

  Baseline, Month 6 and Month 12

• Change from Baseline in ADCS-iADL

  Baseline, Month 6 and Month 12

Study Arms (3)

RB-ADSC low dose

EXPERIMENTAL

Participants will receive repeated doses of 2.5x10\^6 RB-ADSC infused in the previously implanted Ommaya reservoir

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

Biological: RB-ADSC

Placebo control

PLACEBO COMPARATOR

Participants will receive placebo comparator in the previously implanted Ommaya reservoir

Other: Placebo

Interventions

RB-ADSC BIOLOGICAL

RB-ADSC is an investigational an ex-vivo expanded autologous adipose-derived stem cell product

RB-ADSC high dose; RB-ADSC low dose

Placebo OTHER

0.9% NaCl USP

Placebo control

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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)
• No tumors or other disease responsible for dementia
• Participant otherwise in good general health
• Written informed consent from participant or legal representative

You may not qualify if:

• Participant must be able to donate adequate amount of lipoaspirate to establish the final product
• 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
• History of cancer within the past 5 years
• Involvement in other investigational product clinical trial within the past 3 months for monoclonal antibodies, or 6 months for other investigational products

Sponsors & Collaborators

• Regeneration Biomedical, Inc.: lead

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Robert Lynn

CONTACT

877-240-1660; robert@regenerationbiomedical.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: October 3, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: October 3, 2025

Record last verified: 2025-09