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Allogeneic Adipose Tissue Derived-stem Cells in Alzheimer Disease
Sponsor: University Hospital, Toulouse
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.
Official title: Allogeneic Intraveinous Injection of Adipose Tissue Derived-mesenchymal Stem Cells in Mild to Moderate Alzheimer Disease: a Phase I/II Trial
Key Details
Gender
All
Age Range
50 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
9
Start Date
2026-03-01
Completion Date
2029-03-01
Last Updated
2026-01-26
Healthy Volunteers
No
Conditions
Interventions
CellREADY® 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.
CellREADY® 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.
cerebral RMI
cerebral RMI at V1, V5 and V6
PET scan
amyloïde PET scan (flutémétamol) at V1 and V6