Stem cells therapies found safe for pelvic floor disorders: Study
Pelvic foor disorders (PFDs) include a series of conditions related to a weakening of the pelvic muscles and/or tears of the endopelvic fascia, usually related to obstetric trauma. The most prevalent PFDs include genital prolapse, stress urinary incontinence, and anal incontinence. As a consequence, related symptoms may involve alteration of vaginal, bowel, lower urinary tract, and sexual wellbeing. They can be poorly tolerated, negatively affecting the quality of life, impairing social and daily activities, and be the cause of emotional distress and isolation. Management of PFDs traditionally involves pelvic foor rehabilitation and subsequent surgical repair in case of conservative therapy failure. Regenerative medicine might offer an alternative treatment strategy. Stem cells (SCs) represent a promising tool for tissue engineering, in particular for skeletal and connective tissue repair. SCs possess multipotent differentiation capabilities, in addition to the fact that they are harvested from multiple tissues (such as muscular and adipose tissue) and expanded in vitro. Possible applications of stem cells in PFDs include prolapse, stress urinary incontinence, and anal incontinence repair.
For the treatment of stress urinary incontinence, of particular interest is the implantation of autologous muscle stem cells into the sphincter area to strengthen and restore its function. Despite the clinical evidence is very limited, the procedure appears to be safe and efective and represents a new potential strategy to treat anal incontinence caused by anal sphincter defects. However, safety and efficacy data of SCs for pelvic floor dysfunctions in clinical studies are scarce and limited to small populations.
Stefano Manodoro et al aimed to define the state of the art of stem cell therapy for pelvic foor disorders in clinical trials, by systematically reviewing the available evidence.
This systematic review aimed to define the state of art of SC therapy for PFDs in clinical trials, by systematically reviewing the available evidence. A systematic search strategy was conducted up to November 7, 2020, in PubMed, Scopus, Cochrane Library, and ISI Web of Science. Preclinical studies on animal models were not considered. Studies were included when the patients were affected by any PFDs and cells were isolated, cultured, and characterized as SC. A total of 11 prospective clinical studies were included in the final assessment, specifically 7 single-arm studies dealing with SC therapy for stress urinary incontinence and 4 with anal incontinence. Among the latter, there were two prospective, single-arm studies and two randomized controlled trials. No papers concerning the use of SC for prolapse repair were retrieved. Due to the great heterogeneity, data pooling was not possible.
Stem cells and regenerative medicine represent a promising alternative option for the treatment of PFDs. However, safety and efficacy data of SCs for pelvic floor dysfunctions in clinical studies are scarce and limited to small populations. This systematic review identified seven and four clinical studies regarding stem cell therapy for stress urinary and anal incontinence respectively, while none was found for pelvic organ prolapse. Overall, the number of patients who underwent SC therapy was limited.
Stem cell injection resulted in a safe procedure, with few mild adverse side effects, mostly related to harvesting sites. Moreover, due to great heterogeneity in terms of study design, inclusion criteria, stem cell harvesting/delivery, outcome measures, and time points, data pooling was not possible. However, reported outcomes were contrasting, and a clear beneficial impact of SC treatment for the treatment of pelvic floor disorders could not be demonstrated.
In conclusion, the systematic review found the currently studied SC therapies for pelvic floor disorders to be safe procedures. However, authors did not find clear evidence for a beneficial impact of SC treatment for the treatment of pelvic floor disorders. The role of SCs in the treatment of pelvic floor disorders needs to be further evaluated in larger targeted studies with control arms before any conclusions can be made.
Source: Stefano Manodoro, Matteo Frigerio, Marta Barba; Reproductive Sciences (2022) 29:1710–1720
https://doi.org/10.1007/s43032-021-00745-6
