Between June 2025 and March 2026, the COHERENCE project completed a decisive phase on the path towards the future clinical application of the advanced therapy developed within the initiative.
In June 2025, Gaia Cell and Crystal Medical Center began consultations with the relevant regulatory authorities while simultaneously preparing the authorization documentation and clinical protocol. This was one of the project’s most complex and strategically important stages, fully aligned with COHERENCE’s objective of facilitating the transfer of advanced therapies from the laboratory into clinical practice.
The work brought together scientific, clinical and regulatory expertise within a shared cross-border approach, supporting both a first-in-human study and the assessment of the requirements for access to the hospital exemption pathway.
In March 2026, the final feedback from the Slovenian regulatory authorities brought this phase to a close and opened the way for the next steps towards hospital exemption. This achievement provides concrete evidence of how cooperation between Italian and Slovenian partners can guide an advanced therapy through the necessary technical, clinical and regulatory stages, bringing it closer to future clinical application.
