CHU Toulouse and Cell-Easy Launch A-MUSE, a Phase 1/2 Clinical Trial Evaluating the CellReady® Allogeneic MSC Platform in Systemic Sclerosis
Toulouse, January 22, 2026 — Cell-Easy, a CDMO specialized in the development and GMP manufacturing of Advanced Therapy Medicinal Products (ATMPs), announces a new clinical milestone achieved in close collaboration with Toulouse University Hospital (CHU Toulouse). The European Medicines Agency (EMA) has granted Clinical Trial Authorization (CTA) for AMUSE, a Phase 1/2 clinical trial evaluating the safety and efficacy of an allogeneic mesenchymal stromal cell (MSC) therapy in patients with systemic sclerosis presenting perioral fibrosis and functional impairment.
A-MUSE: Addressing a High Unmet Medical Need
Systemic sclerosis is a rare autoimmune disease characterized by progressive fibrosis, vascular dysfunction, and significant functional impairment. Perioral fibrosis is a particularly disabling manifestation, with a major impact on quality of life and no effective therapeutic options available to date.
The A-MUSE trial will assess whether local injections of allogeneic MSCs can reduce fibrosis, improve perioral mobility, and restore functional capacity. MSCs are known for their immunomodulatory, anti-fibrotic, and regenerative properties, supporting their clinical evaluation in this indication.
From Clinical Need to Cell Therapy Product: the Origin of CellReady®
The A-MUSE trial originates from a clinical initiative led by investigators at CHU Toulouse. Confronted with the absence of effective therapeutic options for patients with systemic sclerosis, the clinical team engaged Cell-Easy to assess the feasibility of developing a cell therapy product suitable for clinical evaluation.
In response, Cell-Easy designed and developed in 30 months a GMP-compliant MSC manufacturing platform tailored for clinical use. This platform, named CellReady®, enables standardized, regulatory-compliant, and cost-controlled manufacturing of MSCs. It is currently being evaluated across multiple therapeutic indications.
A Model for Rapid Clinical Translation
With A-MUSE, Cell-Easy illustrates its ability to translate a complex ATMP from early development to First-in-Human (FIH) clinical evaluation.
The CellReady® platform provides a foundation for future ATMP projects by enabling:
- CMC expertise to design and implement standardized, regulatory-compliant, and cost- controlled GMP manufacturing processes,
- short GMP manufacturing and batch release timelines (typically <3 months),
- well-structured CTA dossiers enabling rapid authorization (<6 months).
“CellReady® was conceived as a pragmatic response to clinicians’ needs,” said Guillaume Lay, Chief Commercial Officer at Cell-Easy. “A-MUSE shows how structured CDMO expertise can support the rapid transition from a clinical concept to a ready-to-use ATMP.”
“Our role is to help transform promising ATMP concepts into clinically actionable therapies,” added Cindy Cavelier, Cell-Easy Quality Person. “Whether originating from academia, startups, or biotech companies, we provide the operational, CMC, and regulatory framework required to reach patients in a controlled and compliant manner.”
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 co-coordinator 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. 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). www.chu-toulouse.fr
About Cell-Easy
Founded in 2017, Cell-Easy is a CDMO dedicated to advanced cell therapies. The company supports biotech and pharmaceutical companies worldwide through process and analytical development, GMP manufacturing, and CMC and regulatory support.
Cell-Easy works across multiple cell therapy modalities, including T cells, NK cells, macrophages, MSCs, HSCs, and immortalized cell lines, in oncology, autoimmune diseases, and regenerative medicine. Its science-driven teams apply Quality-by-Design principles to enable robust technology transfer and development.
Beyond conventional CDMO services, Cell-Easy provides access to clinical networks, human biological materials, and integrated CMC and regulatory expertise to support rapid clinical translation and efficient market access.