Abstract
Aim: The treatment of perianal fistulas in Crohn's disease (CD) is a challenge. Adipose-derived stem cells (ADSCs) are an option for treating fistulas, but their behavior at the injection site still needs to be further investigated. The efficacy and safety of autologous transplantation of ADSCs of patients with refractory perianal fistulizing CD was evaluated. Method: A total of 6 patients (18-48 years) were recruited. The intervention was three applications of autologous ADSCs (total of 3x107 cells). The evaluations happened in the 12th and 24th week after the first application, been considered primary and secondary efficacy outcomes, safety outcomes, anthropometric and food quality assessments. Results: Three patients completed the study and been treated 8 fistulas with ADSCs, none application-related effect was observed. The healing closure of the external part occurred in four fistulas, with local reepithelialization, and also two closed completely in the 12th week. The Van Assche index indicates improvement in only one of the patients. On the other hand, the Clinical Perianal Disease Activity Index and the quality of life assessment indicated progress for the three patients until the end of the study. By the CD Simple Endoscopic Score, two patients had the disease endoscopically inactive at the end of follow-up. Most of the anthropometric measurements were adequate and the foods that had low consumption throughout the study, in conformity for the three evaluated, were those belonging to the group of beans. Conclusion: It is concluded that autologous ADSCs have clinical potential to safely treat refractory perianal fistulizing CD.
Highlights
Crohn's disease (CD) is an inflammatory bowel disease (IBD) that is characterized by chronic, transmural and recurrent inflammation of any part of the gastrointestinal tract (Torres et al, 2017), and that results from the interaction between genetic predisposition, environmental factors and uncontrolled immune responses (Zhang et al, 2018)
Exclusion criteria were: patients not refractory to conventional drug and/or surgical treatment; diagnosis of autoimmune disease or inflammatory bowel disease other than CD; infection that required antibiotic treatment; carriers of the Human Immunodeficiency Virus (HIV); with a previous history of treatment for cancer or other malignant disease, as well as other comorbidities, such as heart disease, liver disease, active infectious diseases, toxic megacolon and those with the presence of active tuberculosis confirmed by chest X-ray; who presented physical conditions that excluded the possibility of undergoing liposuction; pregnant and breastfeeding women
Six patients were included in the study, but only three completed the intervention and follow-up process at 12 and 24 weeks, respectively, because one chose to cancel their participation in the study, another presented worsening of the fistulizing disease, requiring colectomy and colostomy and, the third one, did not respond to the Adipose-derived stem cells (ADSCs) extraction procedure after three spaced attempts
Summary
Crohn's disease (CD) is an inflammatory bowel disease (IBD) that is characterized by chronic, transmural and recurrent inflammation of any part of the gastrointestinal tract (Torres et al, 2017), and that results from the interaction between genetic predisposition, environmental factors and uncontrolled immune responses (Zhang et al, 2018). It can lead to symptoms such as abdominal pain, diarrhea with passing blood or mucus, intestinal obstruction (Torres et al, 2017), fatigue, weight loss, fever, anemia and perianal lesions such as fissures, ulcers, abscesses and fistulas (Ott; Scholmerich et al, 2013). Others may present extra-intestinal systemic manifestations and, together, these factors increase the risk of hospitalization, surgeries and impact on quality of life (Torres et al, 2017). Fistulas are manifestations that characterize a penetrating disease (Ott; Scholmerich et al, 2013), those of the most prevalent is perianal type (Eglinton et al, 2012). Its treatment represents a challenge, as there are few pharmacotherapies aimed at this type of manifestation (Gecse et al, 2014). There is a need for more effective treatments, especially for patients who are refractory to existing therapies (Panes et al, 2018)
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