Safety of Allogeneic Adipose Tissue-Derived Mesenchymal Stem Cells for the Treatment of Complex Perianal Fistulas Not Associated With Crohn's Disease: A Phase I Clinical Trial.

BACKGROUND: Anal fistula treatment aims to eradicate the fistula, preserve the sphincter, prevent recurrence, and allow an early return to daily activities for the patient. Because of the difficulty of achieving these goals, stem cell-based therapy has emerged for the treatment of complex perianal fistula with promising results. OBJECTIVE: The objective of this study was to evaluate the safety of allogeneic mesenchymal stem cells in the treatment of complex anal fistula in patients without Crohn's disease. DESIGN: This was a prospective nonrandomized phase I clinical trial. SETTINGS: This study was conducted at a second-level hospital. PATIENTS: Twenty consecutive patients diagnosed with a complex fistula were included. INTERVENTIONS: All patients received 40 × 106 allogeneic mesenchymal stem cells. In patients with 2 tracts, 20 × 106 stem cells were applied on each tract. MAIN OUTCOME MEASURES: The patients were discharged 24 hours after the procedure and were evaluated at 1, 2, 4, 8, 16, and 24 weeks after the application. The long-term follow-up was performed 1 year after the procedure. RESULTS: The procedure was performed in a total of 20 patients from October 1, 2016, to October 31, 2017; 1 patient was eliminated from the final data analysis. No adverse effects were reported within the first 24 hours, and all the patients were discharged asymptomatic. Three patients (15%) presented with perianal abscess. In 1 patient, the abscess appeared at the fourth week, and, in the other 2 patients, the abscess was diagnosed at week 8. Complete closure was achieved in 13 (69%) patients. LIMITATIONS: This was a nonrandomized controlled trial. CONCLUSION: The use of allogeneic mesenchymal stem cells as a treatment is a safe option for the management of complex perianal fistula not associated with Crohn's disease. See Video Abstract at http://links.lww.com/DCR/B443. SEGURIDAD DE LAS CLULAS MADRE MESENQUIMALES ALOGNICAS DERIVADAS DEL TEJIDO ADIPOSO PARA EL TRATAMIENTO DE FSTULAS PERIANALES COMPLEJAS NO ASOCIADAS CON LA ENFERMEDAD DE CROHN ENSAYO CLNICO DE FASE I: ANTECEDENTES:El tratamiento de la fístula anal tiene como objetivo erradicar la fístula, preservar el esfínter, prevenir la recurrencia y permitir un retorno temprano a las actividades diarias del paciente. Debido a la dificultad de alcanzar estos objetivos, ha surgido una terapia basada en células madre para el tratamiento de la fístula perianal compleja con resultados prometedores.OBJETIVO:El objetivo de este estudio fue evaluar la seguridad de las células madre mesenquimales alogénicas en el tratamiento de la fístula anal compleja en pacientes sin enfermedad de Crohn.DISEÑO:Este fue un ensayo clínico prospectivo no aleatorizado de fase I.AMBIENTE:Este estudio se realizó en un hospital de segundo nivel.PACIENTES:Veinte pacientes consecutivos diagnosticados de fístula compleja.INTERVENCIONES:Todos los pacientes recibieron 40 x 106 células madre mesenquimales alogénicas, en pacientes con dos tractos, se aplicaron 20 x 106 células madre en cada tracto.PRINCIPALES MEDIDAS DE RESULTADO:Los pacientes fueron dados de alta 24 horas después del procedimiento y fueron evaluados 1, 2, 4, 8, 16, 24 semanas después de la aplicación. El seguimiento a largo plazo se realizó un año después del procedimiento.RESULTADOS:El procedimiento se realizó en un total de 20 pacientes desde el 1 de octubre de 2016 al 31 de octubre de 2017; un paciente fue eliminado del análisis de datos final. No se informaron efectos adversos en las primeras 24 horas, todos los pacientes fueron dados de alta asintomáticos. Tres pacientes (15%) presentaron absceso perianal. En un paciente, el absceso apareció a la cuarta semana y en los otros dos pacientes el absceso se diagnosticó en la octava semana. El cierre completo se logró en 13 (69%) de los pacientes.LIMITACIONES:Este fue un ensayo controlado no aleatorio.CONCLUSIÓN:El uso de células madre mesenquimales alogénicas como tratamiento es una opción segura para el manejo de la fístula perianal compleja no asociada con la enfermedad de Crohn. Consulte Video Resumen en http://links.lww.com/DCR/B443.

The evaluation of bacteriology in perianal abscesses of 81 adult patients.

OBJECTIVE: Treatment of perianal abscesses requires prompt surgical drainage and antimicrobial therapy. However, we should encourage the selective use of antimicrobial agents on a case-by-case basis, especially because there is no evidence that uncomplicated perianal abscesses can be safely treated only with drainage. For this reason, it is important to identify the causative organisms; therefore, we accessed the microbiological analysis of these patients. PATIENTS AND METHODS: In this study, 81 consecutive adult patients with perianal abscesses, who presented at a university hospital in Diyarbakir from January 2004 to December 2006, were included. Clinical and laboratory data, and results of microbiological analysis were recorded. RESULTS: All specimens, except seven, yielded bacterial growth. Escherichia coli, Bacteriodes spp., coagulase-negative Staphylococci, and Staphylococcus aureus were the most common isolated organisms. CONCLUSION: In contrast to other investigators, this study demonstrated that aerobic organisms are the predominant isolates in these infections.

The evaluation of bacteriology in perianal abscesses of 81 adult patients

OBJECTIVE: Treatment of perianal abscesses requires prompt surgical drainage and antimicrobial therapy. However, we should encourage the selective use of antimicrobial agents on a case-by-case basis, especially because there is no evidence that uncomplicated perianal abscesses can be safely treated only with drainage. For this reason, it is important to identify the causative organisms; therefore, we accessed the microbiological analysis of these patients. PATIENTS AND METHODS: In this study, 81 consecutive adult patients with perianal abscesses, who presented at a university hospital in Diyarbakir from January 2004 to December 2006, were included. Clinical and laboratory data, and results of microbiological analysis were recorded. RESULTS: All specimens, except seven, yielded bacterial growth. Escherichia coli, Bacteriodes spp., coagulase-negative Staphylococci, and Staphylococcus aureus were the most common isolated organisms. CONCLUSION: In contrast to other investigators, this study demonstrated that aerobic organisms are the predominant isolates in these infections.

[Perianal tuberculosis: report of two cases]. / Ulceración perianal: Dos casos de una rara manifestación de tuberculosis extrapulmonar.

Perianal tuberculosis is an uncommon variant of extra pulmonary tuberculosis and mimics other common perianal conditions. We report two patients with perianal tuberculosis. An 82-year-old male presenting with purulent perianal discharge and weight loss. A pelvic magnetic resonance imaging showed a low trans sphincteric anorectal fistula with abscess formation. A fistulectomy was performed and the pathological study showed a granulomatous-tuberculous chronic inflammation. Mycobacteria were recovered from gastric contents. A 48-year-old male with the same symptoms. An ulcerated lesion in the anal region was biopsied, disclosing a granulomatous inflammatory process with Ziehl-Nielsen stainable organisms.

Ulceración perianal: Dos casos de una rara manifestación de tuberculosis extrapulmonar / Perianal tuberculosis: Report of two cases

Perianal tuberculosis is an uncommon variant of extra pulmonary tuberculosis and mimics other common perianal conditions. We report two patients with perianal tuberculosis. An 82-year-old male presenting with purulent perianal discharge and weight loss. A pelvic magnetic resonance imaging showed a low trans sphincteric anorectal fistula with abscess formation. A fistulectomy was performed and the pathological study showed a granulomatous-tuberculous chronic inflammation. Mycobacteria were recovered from gastric contents. A 48-year-old male with the same symptoms. An ulcerated lesion in the anal region was biopsied, disclosing a granulomatous inflammatory process with Ziehl-Nielsen stainable organisms.

Randomized, comparative efficacy trial of oral penicillin versus cefuroxime for perianal streptococcal dermatitis in children.

OBJECTIVE: To investigate the efficacy of penicillin compared with cefuroxime for group A beta-hemolytic Streptococcus pyogenes (GABHS) perianal dermatitis. STUDY DESIGN: Children 1 to 16 years of age with signs and symptoms of perianal dermatitis and a positive anal swab were randomized to penicillin or cefuroxime treatment and were clinically re-evaluated on day 3 and at the end of treatment (cefuroxime, day 7; penicillin, day 10). An anal swab was obtained to document eradication of GABHS at the end of treatment. Severity of disease was assessed with a clinical score (perianal erythema, 5 points; perianal itch, 3 points; painful defecation, 3 points; constipation, 2 points). RESULTS: Patients were enrolled and randomly assigned to penicillin (n = 18) or cefuroxime (n = 17) treatment. Treatment with penicillin was inferior to cefuroxime, which led to premature study termination after consultation with the ethics committee. Clinical improvement was more rapid in the cefuroxime group (P = .028) and GAHBS was not isolated from the anus the last day of therapy in 13 of 14 patients treated with cefuroxime compared with 7 of 15 patients treated with penicillin (P < .01). CONCLUSIONS: Cefuroxime was more effective than penicillin and therefore should be considered as the treatment of choice for perianal dermatitis due to GABHS.

Anal paracoccidioidomycosis: an unusual presentation of disseminated disease.

We report a patient with an unusual anal ulceration. The biopsy of an anal lesion and subsequent studies revealed a disseminated form of paracoccidioidomycosis, observed in the lungs, small and large bowel. The anorectal disease frequently represents a secondary site of disease, and the patient must be better evaluated.

Enfermedad estreptocócica perianal y psoriasis gutata: a propósito de dos casos infantiles / Perianal streptococcal disease and psoriasis guttata: a propos of 2 infantile cases

Se presentan dos casos infantiles de psoriasis gutata y eritema perianal persistente donde se aisló el estreptococo beta hemolítico del grupo A. Se quiere recalcar la importancia de buscar el reservorio perianal del estreptococo en el niño con psoriasis en gotas, además de los clásicos focos faríngeos y nasales. El tratamiento empleado fue penicilina V oral (100.000 U/kg/d) durante 3 semanas más rifampicina (20 mg/kg/d) durante 10 días por la persistencia clínica del eritema perianal y la positividad del cultivo. La duración del tratamiento está determinada por la remisión del cuadro clínico y la negativización de los cultivos perianales

Enfermedad estreptocócica perianal y psoriasis gutata: a propósito de dos casos infantiles / Perianal streptococcal disease and psoriasis guttata: a propos of 2 infantile cases

Se presentan dos casos infantiles de psoriasis gutata y eritema perianal persistente donde se aisló el estreptococo beta hemolítico del grupo A. Se quiere recalcar la importancia de buscar el reservorio perianal del estreptococo en el niño con psoriasis en gotas, además de los clásicos focos faríngeos y nasales. El tratamiento empleado fue penicilina V oral (100.000 U/kg/d) durante 3 semanas más rifampicina (20 mg/kg/d) durante 10 días por la persistencia clínica del eritema perianal y la positividad del cultivo. La duración del tratamiento está determinada por la remisión del cuadro clínico y la negativización de los cultivos perianales