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

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.

Interventions

• RB-ADSC · BIOLOGICAL

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

• Placebo · OTHER

  0.9% NaCl USP

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

Inclusion Criteria:

* ≥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
* 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

Exclusion Criteria:

* 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
* 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

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