CHU Toulouse receives CTA Approval to initiate ALLOFIST, a Phase 1/2 Trial based on Cell-Easy’s proprietary adipose-derived MSC in Patients suffering from Crohn Disease.
Toulouse, France, January 15, 2025
The long-term partnership between Cell-Easy and Toulouse University Hospital (CHU Toulouse) continues to bear fruits, bringing innovative MSC-based therapies to local patient cohorts. This time, it’s in the field of Crohn’s disease that the pair is experimenting with the allogeneic cell therapy approach. By tackling all CMC, regulatory and medico-economic concerns, the Cell-Easy CDMO has succeeded in developing a cell therapy drug from scratch in just 2 years. The principal investigator Dr Etienne Buscail, a colo-rectal surgeon and proctologist at Toulouse University Hospital, recently submitted a request for authorization of CTA to the European Agency EMA, which was rapidly accepted. An initial cohort of patients suffering from Crohn’s disease will be able to benefit from this experimental innovant treatment starting in 2025 Q1.
CHU Toulouse is sponsoring a bicentric clinical project entitled “ALLOFIST” a Phase I/II study of dose-escalation cell therapy for the treatment of ano-perianal fistulas associated with Crohn’s disease, using intrafistular injection of allogeneic Adipose derived Stroma/Stem Cells (AdMSC), registered under number RC31/13/7030, coordinated by Dr. Etienne BUSCAIL (Colo rectal surgeon and proctologist).
Perianal fistulas are in the forefront of morbid complication of Crohn’s disease, affecting nearly one-third of patients and complicating abscesses in 35-48% of cases. The current treatment is based on the combination of drainage (proctologic and surgical), and biologics techniques, but the failure rate varies from 30 to 80%. Cell therapy, and more specifically allogenic mesenchymal stem cells, represent a promising option in the treatment of perianal fistulas associated with Crohn’s disease thanks to their immunomodulatory, anti-inflammatory, angiogenic and trophic properties. This Phase I/II study aims to evaluate the safety and efficacy of AdMSC for the treatment of complex perianal fistulas associated with Crohn’s disease, following the failure of conventional therapies. Different doses of AdMSC will be tested for a dose escalation (5.10*7 and 10.10*7 cells).
The use of AdMSC in different disease areas was born from the initial ambition of local clinicians to offer cutting-edge therapeutic solutions to patients. Cell-Easy, a cell therapy expert CDMO with a strong track record in stem cells, developed CellReady®, a robust allogenic process providing the necessary AdMSC doses for ALLOFIST and other clinical studies. It took the French CDMO, 24 months to meet the challenge faced by startups and biotechs worldwide: completing the pharmaceutical development, scaling up the process, and manufacturing an injectable cell product for human use while adhering to the regulatory requirements and minimizing the dose-cost.
The pharmaceutical development strategy employed by Cell-Easy has not only met clinicians’ expectations regarding the quality of the drug product (safety, identity, and potency) but has also considered the economic aspects of these costly therapies. By scaling-up the AdMSC manufacturing process, Cell-Easy has enabled a significant increase in production volume, effectively reducing CellReady® dose costs.
“As a reliable CDMO player, it is essential to provide complete satisfaction to both cell therapy Biotechs developers by meeting their timelines and budgets, as well as to Clinicians who demand GMP-controlled manufacture of ATMPs in line with regulatory requirements. This partnership once again demonstrates Cell-Easy's thorough understanding of the needs of Cell Therapy stakeholders, enabling the implementation of a safe and timely First-in-Human (FiH) access plan.” _ Guillaume Lay, CCO Cell-Easy.
About Etienne Buscail, coordinating investigator
Etienne Buscail MD PhD is a colorectal surgeon and proctologist at the Toulouse University Hospital. He specializes in the management of inflammatory bowel disease as part of a reference team for the management of inflammatory bowel disease. He has developed a specific expertise in the management of anal fistulas, particularly in Crohn’s disease. Dr Etienne Buscail is a member of the national research team of rectal cancer (GRECCAR), inflammatory bowel disease surgery (GETAID Chirurgie), and proctology (SNFCP). His areas of research are: colorectal cancer, pathological inflammatory processes of the intestine and anus. He is a member of the Institute of Digestive Health Research (IRSD), INSERM U 1220. He has led several clinical and translational studies on digestive cancer and inflammatory phenomena of the digestive tract.
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
Cell-Easy is a global Contract Development and Manufacturing Organization (CDMO) with a dedicated focus on advanced cell therapies. Established in 2017, Cell-Easy’s commitment extends beyond development and manufacturing; it also places a strong emphasis on regulatory and CMC requirements.
Cell-Easy is a science-driven CDMO specialized on advanced Cell Therapies. Cell-Easy offers a broad range of Services, including Process and Analytical development, GMP manufacturing and CMC/Regulatory support for global Biotechs & Pharmas. The scientific team and QbD approach enable seamless technology transfer and development for cell-based therapies in the fields of oncology, autoimmune diseases and regenerative medicine (T cells, NK cells, Macrophages, MSCs, HSCs and exosomes).
In addition to its role as a conventional CDMO, Cell-Easy provides a range of added-value services, including: i) access to patients through an extensive network of national clinicians, ii) access to the human biological materials necessary to produce cell therapies, and iii) comprehensive CMC and regulatory support to accelerate the market approval of these cutting-edge therapies.
