The COHERENCE project has reached an important milestone: the first two patients affected by difficult-to-heal wounds have received an innovative advanced therapy as part of an ongoing case-series study conducted under the Hospital Exemption framework.
The treatment is based on autologous mesenchymal stromal cells derived from the patients’ own adipose tissue. The cells are manufactured under controlled GMP conditions using a standardized, closed-system process and are intended to promote tissue vascularisation and support the healing of chronic wounds.
This achievement represents a key step in the clinical pilot action of COHERENCE — Cross bOrder HEalth REgulatory alliaNCE for advanced therapies. The study is still in progress, and the treated patients will continue to be closely monitored. Its planned assessments include the feasibility and safety of the treatment, wound healing, vascularisation and the patients’ overall quality of life. As patient recruitment and follow-up are ongoing, no conclusions regarding the therapy’s safety or efficacy can yet be drawn. The COHERENCE partners look forward to analysing and sharing the results once the study and the required observation period have been completed.
