CLEIO brings together French stakeholders in Advanced Therapy Medicinal Products (ATMPs) within a harmonized and interconnected national network. The network works to standardize practices, develop expertise, and advance regulatory frameworks tailored to ITMs. By enhancing France’s appeal, CLEIO facilitates clinical trials, accelerates patient enrollment, and supports France’s international influence in the field of ITMs.
CLEIO, the network of expertise on advanced therapy medicinal products
The CLEIO Network of Excellence was established and awarded F-CRIN status in October 2025 to meet growing demand in the field of Advanced Therapy Medicinal Products (ATMPs). CLEIO brings together French stakeholders involved in the development and implementation of these therapies to build an ambitious, coordinated, and sustainable national initiative. To date, the network brings together 11 hospitals around a common goal: to strengthen France’s capacity to develop, produce, and administer the innovative therapies of the future.
CLEIO works to harmonize practices across centers and streamline care pathways for MTI through the standardization of procedures, the sharing of expertise, and the establishment of a dialogue with health authorities. This coordination aims to improve the quality, safety, and effectiveness of activities carried out at the national and then European levels.
The network also helps establish a nationwide network of equipped, certified, and interconnected centers to ensure more consistent access to therapeutic innovations throughout the country. At the same time, CLEIO seeks to support skills development through the creation of training programs for healthcare professionals, academics, and the general public
By enhancing France’s appeal in the field of MTI, CLEIO positions itself as a key player in the implementation of clinical trials that accelerate patient enrollment and helps increase the international visibility of French expertise. The network thus actively contributes to the development of an innovative national ecosystem serving patients and research.
Organization
The CELIO network is currently coordinated by Prof. Vincent Laugel (Strasbourg University Hospitals), Prof. Michaela Semeraro (Clinical Research Center, INSERM CIC1419, Necker Hospital, AP-HP) and Prof. Grégory Pugnet (Toulouse University Hospital).
Haude Schneider serves as the network's project manager.
To carry out its missions, CLEIO also comprises 11 centers located throughout the country.
Scientific Expertise
The CLEIO network is a network of expertise in the field of Innovative Therapies (MTI) in France. These therapies include cell, gene, and tissue therapies. The network brings together expert centers capable of conducting complex clinical trials, providing patient care, and coordinating translational research activities focused on therapeutic innovations.
CLEIO has developed recognized expertise in several complementary areas: harmonization of clinical practices, structuring of patient pathways and medication regimens, management and organization of clinical trials, and training of healthcare professionals. The network also promotes data sharing, interconnection among centers, and the dissemination of best practices to accelerate access to therapeutic innovations.
Through this collaborative approach, CLEIO contributes to the development of a high-performing national ecosystem capable of supporting scientific and technological advances in MTI, while enhancing France’s visibility and appeal on a European and international scale.
Current Projects
The CLEIO network has begun work on the following six topics:
- Define, harmonize, and certify quality pathways for patients and intensive care units
- Define, harmonize, and certify quality requirements for clinical centers
- Implement Good Clinical Practice guidelines for MTI trials
- Monitor data quality and validate processes
- Conduct risk assessment and management
- Network quality approach
- Strengthen collaboration with French networks (CICs, CRIN, FMRs, CMRs/CMCRs/CRCs)
- Organize scientific events
- Increase the visibility and appeal of French clinical research to industry partners in France and internationally
- Maintain ties with French institutions involved in clinical research
- Maintain ties with European institutions and ERNs
- Select and oversee clinical trials
- Harmonize long-term follow-up, pharmacovigilance, and biobanking
- Prepare for the network’s expansion to new trials
- Monitor and report on scientific developments related to MTI
- Help define or evolve regulatory requirements for ATMP trials with regulatory authorities
- Ensure European and international compliance
- Develop standardized procedures and coordinate with the quality management system (WP1)
- Implement a training plan for the centers
- Compile a list of existing MTI training programs
- Participate in existing training programs on MTI
- Develop academic training programs
- Assess the cost-effectiveness of products and processes
- Analyze the economic impact
- Develop sustainable financing strategies
Contact the network
To learn more about the CLEIO network, you can contact the network by sending an email to reseaucleio@gmail.com, or contact Haude Schneider, the network’s project manager: haude.schneider@chru-strasbourg.fr
