The overall ambition of this MUS.I.C. project is to develop a novel tissue-regenerative approach to treat urinary incontinence of female patients, using autologous muscle precursor cells (MPC) in a combination with neuro-muscular electromagnetic stimulation (+NMES).
This includes first, the conduct of the first-in-man trial to show safety, tolerability and efficacy and second, the optimization of the advanced-therapy medicinal product towards totally xeno-free and facilitated manufacturing, as well as a novel injection technique. We envision bringing a safe and efficient therapy method for SUI to the market.
Course of the study
The main objective of the MUS.I.C. project is to conduct a phase I clinical trial (first-in-man, FIM) to assess the safety and tolerability of a new therapeutic regenerative strategy for stress urinary incontinence (SUI) based on the implantation of human muscle progenitor cells (MPCs). Recent advances in cell-based therapies have provided a variety of opportunities to seek alternative solutions to restore damaged sphincter function in patients with urinary incontinence. Functional restoration of the damaged sphincter muscle using a patient’s own cells would be an ideal treatment option that could reverse the underlying pathologic conditions. Various pre-clinical studies have shown promising, concise results towards successful skeletal muscle regeneration using these cells. Building on these data, we envisioned MPCs as a feasible SUI therapy.
In addition, for the first time we will investigate the effect of early neuro-muscular electromagnetic stimulation (+NMES) after cell injection on muscle regeneration. The use of +NMES for the rehabilitation of pelvic floor dysfunction in women with urge-incontinence, stress incontinence and mixed incontinence and in men with post-prostatectomy early incontinence have shown promising results in pilot clinical trials. It avoids post-trauma muscle atrophy, induces muscle hypertrophy and increases the metabolism and turnover of muscle, tripling the expression of muscle markers and significantly improving the recovery of muscle function after trauma. To investigate the effect of this additional therapy on the regeneration process, the patients will be randomized 1:1 after MPC injection in the MPC-group or +NMES MPC-group. Importantly, we already received all the ethical and regulatory approvals to conduct the clinical trial in Zurich.
In addition to the clinical trial, we are extrapolating our research efforts by collaborating with several partners (academic and SMEs), in order to optimize the implementation of the presented MPC +NMES approach in the near future by crucial improvements at scientific, technical and commercial levels. The clinical trial development of MPC +NMES is flanked by projects required for the smooth performance and development of an optimized strategy for future implementation. We are concentrating our efforts towards designing a xeno-free final product (developing a system for human collagen production and utilizing pooled human platelet lysate (pHPL)) with facilitated manufacturing process (using a bioreactor) and, finally, designing a novel injection device for more precise implantation of the cells.