Abstract:Background: Crohn's fistula-in-ano is a refractory disease in colorectal and anal surgery. Although autologous adiposederived stem cell (ADSC) has been used in the treatment of Crohn's fistula-in-ano because of its convenience, nonincision of normal tissue, good tolerance, repeatability, quick recovery, less pain, less damage to anal function, and high quality of life during the perioperative period, there are no reports of its use in China. This is the first clinical trial in China on the treatment of Crohn's… Show more
“…However, we supposed that the principal reason is the lack of the experience of operation, because we did not have any reference of procedures due to the first study in China. In addition, it seems to be lower that the short-term closure rate compared with our previous study in the patients with Crohn’s disease [ 20 ], which may be caused by the small sample size.…”
Section: Discussioncontrasting
confidence: 72%
“…5 ), and injection of ADSC (Fig. 4 c) is the same as that of ADSC treatment of Crohn’s fistula-in-ano which we have reported [ 20 ]. Fig.…”
Section: Methodsmentioning
confidence: 52%
“…We will continue our follow-up and report the results in the future. Otherwise, high cost of ADSC preparation and two operations limit the promotion and application of ADSC in some degree as we have reported before [ 20 ].…”
Section: Discussionmentioning
confidence: 99%
“…Recently, ADSC, a new biotechnology, has also been reported as a safe and effective treatment of complex cryptoglandular perianal fistula (CPAF) in several previously published literatures (Table 1 ) [ 14 – 19 ]. We previously reported the experience of ADSC in the treatment of Crohn’s fistula-in-ano and concluded that it has the following advantages: protecting anal function of patients, relieving pain, allowing a quick recovery, being well-tolerated, and improving the quality of life during postoperative period [ 20 ]. Furthermore, we conducted a clinical study on ADSC in the treatment of complex CPAF.…”
Background
Complex cryptoglandular perianal fistula (CPAF) is a kind of anal fistula that may cause anal incontinence after surgery. Minimally invasive surgery of anal fistula is constantly emerging. Over the past 20 years, there are several sphincter-sparing surgeries, one of which is autologous adipose-derived stem cell (ADSC) transplantation. However, to date, there is no study regarding the treatment of complex CPAF with ADSC in China. This is the first study in China on the treatment of complex CPAF with ADSC to evaluate its safety and efficacy.
Methods
Totally, 24 patients with complex CPAF were enrolled in this prospective case-control study from January 2018 to December 2019 in the National Colorectal Disease Center of Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine. Patients were divided into ADSC group and endorectal advancement flap (ERAF) group according to their desire. The healing of fistulas (healing of all treated fistulas at baseline, confirmed by doctor’s clinical assessment and magnetic resonance imaging or transrectal ultrasonography) was evaluated at week 12 after treatment. In addition to their safety evaluation based on adverse events monitored at each follow-up, the patients were also asked to complete some scoring scales at each follow-up including pain score with visual analog score (VAS) and anal incontinence score with Wexner score.
Results
The closure rates within ADSC group and ERAF group at week 12 were 54.55% (6/11) and 53.85% (7/13), respectively, without significant difference between them. VAS score in ADSC group was significantly lower than that in ERAF group at the 5th day postoperatively [1(0,2) VS 2(2,4), p = 0.011], but no differences were observed at the other time. Wexner score of all patients was not increased with no significant differences between the two groups. Adverse events were observed fewer in ADSC group (27.27%) than that in ERAF group (53.85%), but there was no significant difference between them.
Conclusion
This study indicated safety and efficiency of ADSC for the treatment of complex CPAF in the short term, which is not inferior to that of ERAF. ADSC may provide a promised and potential treatment for complex CPAF conforming to the future of the treatment, which is reconstruction and regeneration.
Trail registration
ChiCTR, ChiCTR1800014599. Registered 23 January 2018—retrospectively registered, http://www.chictr.org.cn/showproj.aspx?proj=24548
“…However, we supposed that the principal reason is the lack of the experience of operation, because we did not have any reference of procedures due to the first study in China. In addition, it seems to be lower that the short-term closure rate compared with our previous study in the patients with Crohn’s disease [ 20 ], which may be caused by the small sample size.…”
Section: Discussioncontrasting
confidence: 72%
“…5 ), and injection of ADSC (Fig. 4 c) is the same as that of ADSC treatment of Crohn’s fistula-in-ano which we have reported [ 20 ]. Fig.…”
Section: Methodsmentioning
confidence: 52%
“…We will continue our follow-up and report the results in the future. Otherwise, high cost of ADSC preparation and two operations limit the promotion and application of ADSC in some degree as we have reported before [ 20 ].…”
Section: Discussionmentioning
confidence: 99%
“…Recently, ADSC, a new biotechnology, has also been reported as a safe and effective treatment of complex cryptoglandular perianal fistula (CPAF) in several previously published literatures (Table 1 ) [ 14 – 19 ]. We previously reported the experience of ADSC in the treatment of Crohn’s fistula-in-ano and concluded that it has the following advantages: protecting anal function of patients, relieving pain, allowing a quick recovery, being well-tolerated, and improving the quality of life during postoperative period [ 20 ]. Furthermore, we conducted a clinical study on ADSC in the treatment of complex CPAF.…”
Background
Complex cryptoglandular perianal fistula (CPAF) is a kind of anal fistula that may cause anal incontinence after surgery. Minimally invasive surgery of anal fistula is constantly emerging. Over the past 20 years, there are several sphincter-sparing surgeries, one of which is autologous adipose-derived stem cell (ADSC) transplantation. However, to date, there is no study regarding the treatment of complex CPAF with ADSC in China. This is the first study in China on the treatment of complex CPAF with ADSC to evaluate its safety and efficacy.
Methods
Totally, 24 patients with complex CPAF were enrolled in this prospective case-control study from January 2018 to December 2019 in the National Colorectal Disease Center of Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine. Patients were divided into ADSC group and endorectal advancement flap (ERAF) group according to their desire. The healing of fistulas (healing of all treated fistulas at baseline, confirmed by doctor’s clinical assessment and magnetic resonance imaging or transrectal ultrasonography) was evaluated at week 12 after treatment. In addition to their safety evaluation based on adverse events monitored at each follow-up, the patients were also asked to complete some scoring scales at each follow-up including pain score with visual analog score (VAS) and anal incontinence score with Wexner score.
Results
The closure rates within ADSC group and ERAF group at week 12 were 54.55% (6/11) and 53.85% (7/13), respectively, without significant difference between them. VAS score in ADSC group was significantly lower than that in ERAF group at the 5th day postoperatively [1(0,2) VS 2(2,4), p = 0.011], but no differences were observed at the other time. Wexner score of all patients was not increased with no significant differences between the two groups. Adverse events were observed fewer in ADSC group (27.27%) than that in ERAF group (53.85%), but there was no significant difference between them.
Conclusion
This study indicated safety and efficiency of ADSC for the treatment of complex CPAF in the short term, which is not inferior to that of ERAF. ADSC may provide a promised and potential treatment for complex CPAF conforming to the future of the treatment, which is reconstruction and regeneration.
Trail registration
ChiCTR, ChiCTR1800014599. Registered 23 January 2018—retrospectively registered, http://www.chictr.org.cn/showproj.aspx?proj=24548
“…The remaining received SCT with no control group. Eighteen studies used autologous stem cells [ 37 , 44 – 47 , 50 , 55 – 66 ], seven with allogeneic stem cells [ 48 , 49 , 51 , 52 , 67 – 69 ], and both of them were used in other two studies [ 53 , 54 ]. Fig.…”
Background
Fistulas have puzzled us all the time and stem cell therapy for it is still in its infancy. We conducted a meta-analysis and systematic review to evaluate the efficacy of stem cells and its potential mechanisms in the management of Crohn’s fistula.
Methods
Electronic databases were searched comprehensively for studies reporting the efficacy and safety of stem cells in patients with any form of Crohn’s fistula. A random-effects model was used, and all outcomes were calculated by SPSS 24.0.
Results
Twenty-nine articles with 1252 patients were included. It showed that stem cell group had a higher rate of fistula healing compared to placebo group in patients of Crohn’s fistula (61.75% vs 40.46%, OR 2.21, 95% CI 1.19 to 4.11, P < 0.05). 3 × 107 cells/mL stem cell (SC) group had an advantage in fistula healing rate with 71.0% compared to other doses group of stem cells (RR 1.3, 95% CI 0.76 to 2.22). And the healing rates of patients with perianal and transsphincteric fistulas (77.95%, 76.41%) were higher than those with rectovaginal fistulas. It was an amazing phenomenon that CDAI and PDAI scores occurred an obviously transient rise with the use of stem cells after 1 month (both of P < 0.05), while they returned to the baseline level by giving stem cells 3 months later. Furthermore, the incidence rate of treatment-related adverse events in the stem cell group was significantly lower than in the placebo group (RR 0.58, 95% CI 0.30 to 1.14).
Conclusions
Our study has highlighted that stem cells was a promising method in the treatment of Crohn’s fistula based on its higher efficacy and lower incidence of adverse events, especially ADSCs and Cx601. While it also needs more clinical and pre-clinical studies to strengthen evidences in the future.
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