Implantation of autologous muscle-derived stem cells in treatment of fecal incontinence: results of an experimental pilot study

Abstract

BackgroundThe aim of this study is to present results of the implantation of autologous myoblasts into the external anal sphincter (EAS) in ten patients with fecal incontinence.MethodsAfter anatomical and functional assessment of the patients’ EAS, a vastus lateralis muscle open biopsy was performed. Stem cells were extracted from the biopsy specimens and cultured in vitro. Cell suspensions were then administered to the EAS. Patients were scheduled for follow-up visits in 6-week intervals. Total follow-up was 12 months.ResultsAll biopsy and cell implantation procedures were performed without complications. Nine of the patients completed a full 12-month follow-up. There was subjective improvement in six patients (66.7 %). In manometric examinations 18 weeks after implantation, squeeze anal pressures and high-pressure zone length increased in all patients, with particularly significant sphincter function recovery in five patients (55.6 %). Electromyographic (EMG) examination showed an increase in signal amplitude in all patients, detecting elevated numbers of propagating action potentials. Twelve months after implantation two patients experienced deterioration of continence, which was also reflected in the deterioration of manometric and EMG parameters. The remaining four patients (44.4 %) still described their continence as better than before implantation and retained satisfactory functional examination parameters.ConclusionsImplantation of autologous myoblasts gives good short-term results not only in a subjective assessment, but also in objective functional tests. It seems that this promising technology can improve the quality of life of patients with fecal incontinence, but further study is required to achieve better and more persistent results.

Perspective: autologous skeletal muscle cells for the treatment of fecal incontinence

“…One of the ten patients was lost to follow up during the study period. By 18 weeks of follow-up, twothirds of the patients (n = 6) reported subjective improvement in symptoms and over half had improved quantitative parameters of rectal function; however, after 1 year of follow-up, two of these patients exhibited a decline in both their qualitative and quantitative improvements [1]. This report by Romaniszyn et al [1] is among the first to independently confirm the clinical observations from Frudinger et al [5].…”

“…They designed their study based in part on (a) a preclinical rat model reporting that the injection of bone marrow-derived mesenchymal stem cells (MSC), also known as multipotent stromal cells [2], (b) quantitatively improved objective measures of fecal incontinence [3,4]; and (c) a pilot clinical study by Frudinger et al [5] reporting that women with fecal incontinence showed objective improvement in rectal function for up to 1 year following injection of skeletal muscle-derived cells. Here, Romaniszyn et al [1] report positive outcomes in a pilot study treating fecal incontinence with autologous skeletal muscle cell injection. The authors enrolled ten patients (nine females and one male) with severe fecal incontinence that had persisted despite 6 months of conventional biofeedback therapy.…”

“…Consequently, investigators have continued to seek out novel therapeutic approaches. In the current issue of Techniques in Coloproctology, Romaniszyn et al [1] describe a regenerative surgical approach to fecal incontinence. They designed their study based in part on (a) a preclinical rat model reporting that the injection of bone marrow-derived mesenchymal stem cells (MSC), also known as multipotent stromal cells [2], (b) quantitatively improved objective measures of fecal incontinence [3,4]; and (c) a pilot clinical study by Frudinger et al [5] reporting that women with fecal incontinence showed objective improvement in rectal function for up to 1 year following injection of skeletal muscle-derived cells.…”

Functional Outcome of Human Adipose Stem Cell Injections in Rat Anal Sphincter Acute Injury Model

“…To simplify the cell isolation and proliferation process, Mazzanti et al used freshly isolated minimally manipulated bone‐marrow derived mononuclear cells without expansion and found them to be as effective as in vitro expanded BM‐MSCs in the recovery of iatrogenic anal sphincter rupture 38. Muscle‐derived stem cell injections have been used in small pilot studies in women and the results are promising 39, 40, 41. Frudinger et al treated 10 patients with autologous myogenic stem cells and found a significant improvement in the AI symptoms at 1‐ and 5‐year controls.…”

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].…”