Regenerative treatment of male stress urinary incontinence by periurethral injection of autologous adipose‐derived regenerative cells: 1‐year outcomes in 11 patients

Abstract

Abbreviations & AcronymsObjectives: To assess the efficacy and safety of a novel cell therapy for male stress urinary incontinence consisting of periurethral injection of autologous adipose-derived regenerative cells, and to determine the 1-year outcomes. Methods: A total of 11 male patients with persistent stress urinary incontinence after prostate surgery were included in the study. The Celution system was used to isolate adipose-derived regenerative cells from abdominal adipose tissue obtained by liposuction. Subsequently, these regenerative cells, and a mixture of regenerative cells and adipose tissue were transurethrally injected into the rhabdosphincter and submucosal space of the urethra, respectively. The 1-year outcomes were assessed using a 24-h pad test, a validated patient questionnaire, urethral pressure profile, transrectal ultrasonography and magnetic resonance imaging. Results: Stress urinary incontinence improved progressively in eight patients during the 1-year follow up, as determined by a 59.8% decrease in the leakage volume in the 24-h pad test, decreased frequency and amount of incontinence, and improved quality of life. One patient achieved total continence. The mean maximum urethral closing pressure and functional profile length increased from 35.5 to 44.7 cmH2O, and from 20.4 to 26.0 mm, respectively. Magnetic resonance imaging showed the sustained presence of the injected adipose tissue, and enhanced ultrasonography showed a progressive increase in blood flow to the injected area in all patients. No significant adverse events were observed peri-or postoperatively. Conclusion: Periurethral injection of autologous adipose-derived regenerative cells might represent a safe and feasible treatment modality for male stress urinary incontinence.

Histological and Urodynamic Effects of Autologous Stromal Vascular Fraction Extracted from Fat Tissue with Minimal Ex Vivo Manipulation in a Porcine Model of Intrinsic Sphincter Deficiency

“…These were essentially preclinical studies that used isolated muscle progenitor cells or ex vivo cultured MSCs from bone marrow (12), fat (13)(14)(15)(16) or cord blood (17). Four Phase I clinical studies have reported the efficacy of MSC in SUI, (18) in the context of a post-prostatectomy (19) feminine SUI after the failure of a first line pelvi-perineal physiotherapy or surgical treatment (20,21). The appearance of clinical efficacy and a delayed increase in MUP between 3 and 6 months after the injection of MSC were in favour of a simple bulking effect (5).…”

A clinical trial of autologous adipose-derived regenerative cell transplantation for a postoperative enterocutaneous fistula

“…At present, the target diseases of treatment with ADSCs are wide-ranging, including fistulas, ischemic heart disease, peripheral artery disease, inflammatory bowel disease, urinary incontinence, and plastic reconstructive surgery [31][32][33][34][35][36]. Cultured or passaged ADSCs are used to treat some of these diseases [31,32,35]; in other cases, purified ADSCs with noncultured or passaged SVF are administered, as in this study, which used a Celution system [33,34,36]. The results of phase II and III studies of complex anal fistulas, pathologically similar to the enterocutaneous fistulas examined in this study, treated with cultured ADSCs have already been reported [31,32].…”

Oral and Maxillo-Facial

“…Secondly, harvesting procedure of ASC is less complicated and is associated with less morbidity and complications. Several recent studies indicate potential clinical use of ASC in BTE (Zuk et al 2001 ;Sándor et al 2013 ;Gotoh et al 2014 ). Despite the above advantages, both in vitro and in vivo osteogenic ability of ASC seem to be inferior as compared to that of BMSC (Liao and Chen 2014 ).…”