Allogeneic Adipose Tissue Derived-stem Cells in Alzheimer Disease

Bone narrow derived-stem cells (MSC) or adipose tissue-derived stem cells (AdMSC) are widely used in clinical research. The allogeneic approach is currently being considered in indications such as Crohn's disease and graft-versus-host disease. The potential effects of MSCs would be associated with paracrine effects via the secretion of neurotrophic cytokines capable of stimulating endogenous neurogenesis, anti-inflammatory, and immuno-modulatory factors. The recent CRATUS study consisting of IV administration of allogeneic MSCs in frail elderly participants showed a positive effect on functional performance, cognitive performance and inflammation measures. A3D is a phase I/II clinical trial whose primary objective is to evaluate the safety of allogeneic AdMSC IV administration in mild to moderate AD using a dose escalation protocol. Initially, 3 patients will receive the lowest dose (50x106 AdMSC). If the safety analysis of the first 3 patients injected by 50x106 AdMSC does not show clinically significant adverse events (AE) after 6 months of evaluation, 100x106 AdMSC administration may be started in 3 new patients. On the other hand, if the safety analysis of the first 3 patients shows a clinically significant AE related to the treatment, 3 new patients will be infused 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.