Allogeneic Intraveinous Injection of Adipose Tissue Derived-mesenchymal Stem Cells in Mild to Moderate Alzheimer Disease: a Phase I/II Trial
NCT: NCT07367815 ·
Status: NOT YET RECRUITING ·
Phase: Phase 2
· Sponsor: University Hospital, Toulouse
· Started: 2026-03-01
· Est. Completion: 2029-03-01
Official 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.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NON_RANDOMIZED
- Model: SEQUENTIAL
- Masking: NONE
- Enrollment: 9 participants
Interventions
- DRUG: 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 a
- DRUG: 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
- DIAGNOSTIC_TEST: cerebral RMI — cerebral RMI at V1, V5 and V6
- DIAGNOSTIC_TEST: PET scan — amyloïde PET scan (flutémétamol) at V1 and V6
Primary Outcomes
- number of participants in each group with a clinically significant serious or non-serious AE related to treatment (6 months)
Secondary Outcomes
- determination of measures related to immunomodulatory activity (composite outcome) (6 months)
- determination of measures related to cerebral amyloid load (composite outcome) (6 months)
- determination of measures related to neurotrophic activity (composite outcome) (6 months)
More Alzheimer Disease Trials
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.