RecruitingPhase 1Phase 2NCT07367815

Allogeneic Adipose Tissue Derived-stem Cells in Alzheimer Disease

Allogeneic Intraveinous Injection of Adipose Tissue Derived-mesenchymal Stem Cells in Mild to Moderate Alzheimer Disease: a Phase I/II Trial

Sponsor

University Hospital, Toulouse

Enrollment

9 participants

Start Date

May 7, 2026

Study Type

INTERVENTIONAL

Conditions

Alzheimer Disease

Summary

A3D is a phase I/II clinical trial. The primary objective is to evaluate the safety of allogeneic adipose tissue derived-stem cells (AdMSC) administered by intravenous (IV) route in mild to moderate Alzheimer disease (AD) using a dose escalation protocol.

Eligibility

Min Age: 50 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying CellREADY® drug product IV dose of 100 millions, CellREADY® drug product IV dose of 50 millions, and others for people with alzheimer disease. The study is currently recruiting participants at 1 location. People eligible for this study include aged 50 Years to 85 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCellREADY® drug product IV dose of 50 millions

Allogeneic AdMSC (CellREADY® drug product), intravenous administration, dose of 50 millions. Initially, 3 patients will receive the lowest dose (50x106 AdMSC). If the safety analysis of the first 3 patients infused at dose 50x106 AdMSC does not show clinically significant AEs after 6 months of follow-up, 100x106 AdMSC administration may be started in 3 new patients. On the other hand, if safety analysis of the first 3 patients shows a clinically significant AE, 3 new patients will be injected at this same dose before making a final decision on the possibility of dose escalation. Thus, the "100x106 AdMSC " group will only start after the 6-month follow-up and safety analysis completed in the "50x106 AdMSC " group. For each dose, all patients will be followed for 6 months post-injection with 6 visits.

DRUGCellREADY® drug product IV dose of 100 millions

Allogeneic AdMSC (CellREADY® drug product), intravenous administration, dose of 100 millions. Initially, 3 patients will receive the lowest dose (50x106 AdMSC). If the safety analysis of the first 3 patients infused at dose 50x106 AdMSC does not show clinically significant AEs after 6 months of follow-up, 100x106 AdMSC administration may be started in 3 new patients. On the other hand, if safety analysis of the first 3 patients shows a clinically significant AE, 3 new patients will be injected at this same dose before making a final decision on the possibility of dose escalation. Thus, the "100x106 AdMSC " group will only start after the 6-month follow-up and safety analysis completed in the "50x106 AdMSC " group. For each dose, all patients will be followed for 6 months post-injection with 6 visits.

DIAGNOSTIC_TESTcerebral RMI

cerebral RMI at V1, V5 and V6

DIAGNOSTIC_TESTPET scan

amyloïde PET scan (flutémétamol) at V1 and V6