From Clinical Need to First-in-Human: Cell-Easy Supports CHU Toulouse’s A-MUSE Cell Therapy Program
Toulouse, November 12, 2026
Cell-Easy, a contract development and manufacturing organization (CDMO) specializing in cell therapies, announces a major milestone in the A-MUSE clinical program led by Toulouse University Hospital (CHU Toulouse): the first patient just received an allogeneic mesenchymal stromal cell (MSC) therapy manufactured using the CellReady® platform. A-MUSE is a Phase I/II clinical trial evaluating the safety and efficacy of locally administered MSCs in patients with systemic sclerosis presenting perioral fibrosis and functional impairment, a debilitating manifestation of this rare autoimmune disease.
Turning a Clinical Challenge into a Product Ready for Clinical Use
Initiated by clinicians at CHU Toulouse to address an unmet medical need, A-MUSE required the development of an MSC-based investigational medicinal product suitable for clinical evaluation. At the sponsor’s request, Cell-Easy took on the challenge of developing the manufacturing process and establishing the quality and CMC framework required to support the program through to first-in-human administration.
Over approximately 30 months, Cell-Easy helped translate the initial clinical concept into a GMP manufactured cell therapy product ready for clinical evaluation. This work led to the development of CellReady®, illustrating Cell-Easy’s ability to adapt its expertise to the needs of academic sponsors and support the clinical translation of innovative cell therapies.
“A-MUSE illustrates what we aim to deliver as a CDMO: responding to a clinical need, tackling the technical and manufacturing challenges, and supporting the sponsor all the way to first-inhuman administration. Our role is to provide the expertise and operational framework that enable our partners to turn their therapeutic concepts into clinical reality” said Guillaume Lay, Chief Commercial Officer at Cell-Easy.
CellReady®: Balancing Biological Potency, Manufacturing Robustness and Economic Sustainability
The development of CellReady® goes beyond establishing a GMP-compliant manufacturing process.
From the outset, Cell-Easy has focused on addressing three fundamental challenges in MSC based therapies: identifying relevant biological potency assays to characterize the cells’ therapeutic properties, developing a robust and reproducible manufacturing process, and achieving an economically sustainable production model suitable for clinical development. The development and ongoing refinement of CellReady® reflect Cell-Easy’s science-driven approach to cell therapy development: combining biological understanding, pharmaceutical manufacturing expertise and cost-conscious process design to support the development of clinically relevant and economically viable cell therapies.
About Professor Grégory Pugnet, coordinating investigator
Grégory Pugnet, M.D., PhD., coordinating investigator of the multicentric randomized control clinical trial (A-DUSE, NCT04356755, EU CT Number 2023-508432-53-00), is among the few specialists in systemic autoimmune disease; in which he is leading important clinical research activity. He worked for 18 months at the French Reference Center for Systemic Sclerosis in Cochin Hospital (Paris, France). He is an active member of the GFRS (Groupe Francophone de Recherche sur la Sclérodermie), and a member of the scientific committee of the French Reference Center for Cell Therapy in Autoimmune Diseases (MATHEC network), with the FAI2R network, labeled by the French Ministry of Health in 2017. Prof. Pugnet serves as the cocoordinator of the CLEIO network, which was awarded a label in 2025 by F-CRIN and the PNMR4. This comprehensive French national network is dedicated to facilitating both commercial and non-commercial trials of Advanced Therapy Medicinal Products (ATMPs) across various therapeutic areas and multiple specialties.”
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. Jérome Roncalli and Grégory Pugnet, 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. 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). www.chu-toulouse.fr
About Cell-Easy
Founded in 2017 and based in Toulouse, France, Cell-Easy is a CDMO specializing in the development and GMP manufacturing of advanced cell therapies. The company supports academic institutions, biotechnology companies and pharmaceutical developers through process and analytical development, technology transfer, GMP manufacturing, quality control, and CMC and regulatory support.
Contact: info@cell-easy.com