Novel approach to treat fecal incontinence with muscle stem cell-based therapy

It is a pleasure to provide the commentary on the pioneering work of Dr. Romaniszyn and colleagues entitled: ‘‘Implantation of autologous muscle-derived stem cells in treatment of fecal incontinence: Results of an experimental pilot study’’ [1]. Introduction of stem cell-based therapies in the past decade has opened a new treatment options for many disease and clinical conditions where standard therapies have either failed or were ineffective [2]. Fecal incontinence (FI) represents a challenging clinical and healthcare problem. Current methods of treatment both conservative, including pharmacotherapy, biofeedback, silicone elastomer prosthesis (Acticon Neosphincter) [3], as well as radio-frequency energy delivery, and surgical such as sphinctotherapy are not optimal, and long-term results are not satisfactory [4]. This creates a significant medical and social problem in large population of patients with fecal incontinence and affects their daily leaving activities and quality of life. In addition, the financial burden to treat FI as well as related complications is substantial and exceeds $4000 per year in both Europe and the USA [5]. Thus, there is an urgent need to search for new methods and approaches to treat fecal incontinence. Several innovative approaches have been proposed and tested including new devices, pharmacological agents, new biofeedback programs, and sacral and posterior tibial nerve stimulation. However, none of these approaches became a standard of care; thus, the stem cell-based therapies seem to have the best therapeutic potential. Several investigators have published promising results using stem cell therapies in experimental models of incontinent rodents and mongrel dogs [6, 7]. On the basis of existing data, local myoblast [8] and intravenous MSC therapies [9] have achieved the best results. There are numerous reports on clinical application of myoblasts and MSC in treatment of urinary incontinence and muscular dystrophies [10, 11]. Limited data are available with regard to cell therapies in FI patients even though already published results are encouraging [12]. The clinical study of Romaniszyn et al. is representing an innovative approach to treat FI with autologous myoblasts. This pilot prospective experimental clinical trial was approved by appropriate ethical committees and is summarizing the outcomes of ten patients with FI enrolled into the study and treated with autologous muscle-derived stem cells. The standard methods of assessment were employed, including Incontinence Severity Index (ISI) questionnaire, anorectal manometry, surface endoanal electromyography, endorectal ultrasound, and clinical examination. Nine patients were followed up to 12 months. Overall, functional tests confirmed that myoblast stem cell therapy improved continence in 4 patients (44.4 %). This pilot study on a small group of patients has several limitations that were raised by the authors in the Discussion section of the article. These include sparse cohort, dispersal of the patients’ age, short follow-up, postoperative evaluation by means of subjective questionnaire, and postimplantational edema that may be responsible for a ‘‘placebo effect.’’ Furthermore, this method can be applied only in patients with undamaged sphincter innervation. The description of method of myoblast transplantation including clear outline of sites of implantation procedure as well & M. Siemionow siemiom@hotmail.com