| Objective:1.To evaluate the clinical efficacy and safety of autologous ADSC transplantation in the treatment of Crohn’s fistula-in-ano;2.To investigate the effect of Ginsenoside Rg1 on the proliferation of ADSC.Methods:1.22 patients with Crohn’s fistula-in-ano were enrolled in this study from January 2018 to October 2018 in Nanjing Hospital of Traditional Chinese Medicine.They were divided into a control group and a treatment group.There were 11 patients in each group.The treatment group was treated with autologous ADSC transplantation,and the control group was treated with incision-thread-drawing procedure.All patients’ clinical data were collected through 12 months follow-up.The closure and recurrence of fistula was evaluated by clinical evaluation and imaging examination.The patients additionally completed some scoring scales at each follow-up including simplified Crohn’s Disease Activity Index(CDAI),Perianal Disease Activity Index(PDAI),Inflammatory Bowel Disease Questionnaire(IBDQ),pain scores with visual analog score(VAS),and Wexner score.And the data of inflammatory indexes were also collected including CRP,ESR and FC.All safety data were also recorded to evaluate the safety of this study.2.ADSCs were co-cultured with different concentrations of Ginsenoside Rg1 in normal and inflammatory environment induced by TNF-α for 24 hours.The proliferation of ADSCs was detected by CCK-8 method.Results:1.(1)Efficacy:① The healing rates of the treatment group and control group at Month 3,6 and 12 were as follows:90.9%(10/11)vs 45.5%(5/11),72.7%(8/11)vs 54.5%(6/11),63.6%(7/11)vs 54.5%(6/11).There was no significant difference between the two groups.② The recurrence rates of the treatment group and control group at Month 3,6 and 12 were as follows:9.09%(1/11)VS 27.27%(3/11),18.18%(2/11)VS 36.36%(4/11),18.18%(2/11)VS 36.36%(4/11).There was no significant difference between the two groups.③ The improvement of simplified CDAI,Wexner and VAS scores in the treatment group was significantly better than that in the control group(P<0.05),but there was no significant difference in PDAI and IBDQ scores.④The inflammatory indexes(CRP,ESR,FC)of the two groups after treatment were significantly improved(P<0.05),but there was no significant difference in the change of inflammatory indexes between the two groups.(2)Safety:The data of 12 months follow-up showed that adverse events occurred in 63.6%(7/11)patients in the observation group and 100%(11/11)patients in the control group.No adverse event associated with ADSC injection and serious adverse event was observed in the study.And there is no significant difference between the two groups.2.① The primary ADSCs could gradually stretch into short or long spindle shape within 48 hours,and showed typical fibroblast like morphology after the third passage.The immunophenotype of P3 generation ADSCs expressed CD44,CD73,CD90 and CD105,but did not express CD31,CD34 and CD45.② Ginsenoside Rg1 can promote the proliferation of ADSCs in a dose-dependent manner in the range of 0-100 nmol/L.③ TNF-α can promote the proliferation of ADSC at low concentration(0-25 nmol/L),but inhibited the proliferation of ADSC at high concentration(≥ 50 nmol/L).④Ginsenoside Rgl can promote the proliferation of ADSC pretreated in the inflammatory environment induced by 1000 ng/ml TNF-α with a dose-dependent manner in the range of 0-100 nmol/L.Conclusions:1.ADSC transplantation is a safe and effective treatment for Crohn’s fistula-in-ano,which is not inferior to incision-thread-drawing procedure.It can protect anal function of patients,be well-tolerated,relieve pain,allow quick recovery,and improve the quality of life during perioperative period.2.Ginsenoside Rg1 can promote the proliferation of ADSCs,which was in normal and inflammatory environment induced by TNF-α,with a dose-dependent manner in a certain concentration range(0-100 nmol/L). |
PDF Full Text Request