CHU Toulouse and Cell-Easy Receive Regulatory Approval of A3D: A Phase 1 Trial Using CellReady® in Alzheimer’s DiseaseToulouse, May 23rd 2025
Cell-Easy, a Contract Development and Manufacturing Organization (CDMO) specialized in advanced cell therapies, announces that its allogeneic adipose-derived mesenchymal stem cell product, CellReady®, will be investigated in a newly approved Phase 1 clinical trial for Alzheimer’s disease. The A3D trial has received authorization from the French National Agency for Medicines and Health Products Safety (ANSM), along with a positive opinion from the European Medicines Agency (EMA). A3D is sponsored and promoted by CHU Toulouse, in collaboration with the Clinical Investigation Center in Biotherapy (CIC-BT), and coordinated by Dr Julien Delrieu, Principal Investigator of the study.
A3D: Targeting Alzheimer’s Disease with Cell-Based Innovation
A3D (Adipose Adult stem cells in Alzheimer’s Disease) is a First-in-Human trial evaluating the safety and tolerability of intravenously administered allogeneic adipose-derived mesenchymal stem cells in patients with early-stage Alzheimer’s disease.
The study builds on growing preclinical and clinical evidence suggesting that mesenchymal stem cells (MSCs) can reduce neuroinflammation, modulate immune responses, and promote neurogenesis — offering a novel therapeutic approach in a field where current treatments remain largely symptomatic. Preliminary results from related studies, such as CRATUS, have shown encouraging cognitive and functional improvements in elderly individuals following MSC treatment, further supporting the potential of this strategy.
Cell-Easy: From Concept to Clinic — Fast
In the A3D study, Cell-Easy played a central role in bringing an innovative allogeneic MSC therapy to First-in-Human stage. As both
developer and GMP manufacturer of CellReady®, Cell-Easy delivered end-to-end support — from process development and scale-up to
clinical-grade production and regulatory documentation — enabling a swift transition to the clinic.
“This trial demonstrates how focused industrial expertise can directly accelerate clinical access,” said Guillaume Lay, Business Development Director at Cell-Easy. “Our CellReady® platform ensures scalable, compliant, and ready-to-use MSCs — a foundation for rapid clinical entry, even in complex indications like Alzheimer’s.”
Cell-Easy’s impact goes beyond a single trial. The same translational capabilities — GMP readiness, regulatory alignment, and real-world
delivery — apply to any cell therapy program. Whether autologous or allogeneic, early-stage or ready for trial, Cell-Easy enables
developers to move with confidence and speed toward clinical milestones.
About Professor Julien Delrieu, coordinating investigator
Julien Delrieu, M.D., PhD., principal investigator of the Phase I/II A3D clinical trial, is an Alzheimer disease specialist with an important clinical research activity. He decided to focus his clinical practice and research in the area of aging and Alzheimer disease, in particular the prevention of cognitive disorders. In 2008, he started working in the Toulouse Gérontopôle initially in the acute Alzheimer care unit and then head of the memory centre where we assess more than 1500 subjects per year. For more than 10 years, he has participated to major preventive trials in these fields (Multidomain Alzheimer Prevention Trial, NOLAN) and have published more than 90 scientific papers in peer reviewed journal. Currently, he is involved in the Inspire Bio-resource Research Platform for Healthy Aging INSPIRE Platform to better understand the relationship between biological aging and age-related diseases as Alzheimer disease.
About CIC-BT
The Clinical Center of Investigation in BioTherapy (CIC-BT 1436) is an academic organization under the supervision of Toulouse University Hospital (CHUT)/INSERM/University. It was established at the end of 2005 to support researchers and companies developing cell, gene and molecular therapy ATMPs, from the preclinical phases through to the coordination and conduct of phase 1-3 clinical trials. Its structure draws on the expertise of CHUT’s research and innovation department for regulatory aspects when CHUT is the study sponsor. Coordinated by Prof. Louis Buscail, CIC-BT has been responsible for numerous projects, funded by a total of six million euros ($6.4M) (CHU promoter), including five national clinical research hospital programs – Programme Hospitalier de Recherche Clinique (PHRC) (2010, 2013, 2014, 2017 and 2022), three inter-regional PHRCs (2013, 2019 and 2022), one Horizon 2020 program, one SudOE program and two associations. CIC-BT also carries out extensive research in cardiovascular and digestive pathologies, in geriatrics and pediatrics, as well as translational research in collaboration with teams involved in regenerative medicine (RESTORE), neurodegenerative diseases (INFINITY), cardiovascular diseases (I2MC) and oncology (CRCT).
About Cell-Easy
Cell-Easy is a global Contract Development and Manufacturing Organization (CDMO) specializing in advanced cell therapies. We support biotech, pharma, and public institutions with GMP-compliant development and manufacturing.
Our mission: accelerate your cell therapy’s path to market — with patient access as the end goal.
The Cell-Easy team brings practical expertise across a wide range of cell types, engineered or not (T cells, NK cells, Macrophages, MSCs, HSCs, PSCs and any immortalized cell lines). Our services include process diagnostics, development, GMP production, cell banking, cryostorage, and delivery. We also assist with sourcing human biological materials and setting up clinical trials — enabling a smoother transition from concept to clinic. To date, Cell-Easy has supported 10 clinical trials, including collaborations with top 30 pharma, and guided clients in moving from autologous to allogeneic strategies.
Learn more: www.cell-easy.com
Contact: info@cell-easy.com
