Bone Marrow Mononuclear Cells and Plasma Gel as Combination Treatment for Hard-to-Heal Wounds.

Hard-to-heal wounds pose a significant challenge in clinical practice due to the fact that the conventional treatments used are not always effective. For this reason, it is necessary to design alternatives to achieve an adequate resolution. In this context, a new Advanced Therapy product was produced in a Good Manufactured Practices Facility in the setting of a clinical trial authorised for the European Medicines Agency (EUCT 2023-505017-25-02). Briefly, an autologous plasma scaffold containing bone marrow mononuclear cells was applied to a 63-year-old male patient who presented a non-healing wound despite two months of self-care and three months of primary care treatment. After cleaning the affected area, a single-dose plasma scaffold with embedded bone marrow mononuclear cells was applied over the wound. Six weeks after treatment, the wound exhibited remarkable healing with complete closure as evidenced by follow-up assessments at different time points. Quality of life measures significantly improved, aligning with clinical findings, and no adverse effects were observed. While further studies are needed, the issues presented in this case report show the promising results obtained forthe first patient included in the trial and treated with this innovative alternative, which supports the potential of mononuclear cells combined with plasma as a therapeutic option for chronic wounds.