title: Recurrent anal fistulae: limited surgery supported by stem cells.
abstract: OBJECTIVE
  To study the results of stem-cell therapy under a Compassionate-use Program for patients with recurrent anal fistulae.
  
  
  METHODS
  Under controlled circumstances, and approved by European and Spanish laws, a Compassionate-use Program allows the use of stem-cell therapy for patients with very complex anal fistulae. Candidates had previously undergone multiple surgical interventions that had failed to resolve the fistulae, and presented symptomatic recurrence. The intervention consisted of limited surgery (with closure of the internal opening), followed by local implant of stem cells in the fistula-tract wall. Autologous expanded adipose-derived stem cells were the main cell type selected for implant. The first evaluation was performed on the 8(th) postoperative week; outcome was classified as response or partial response. Evaluation one year after the intervention confirmed if complete healing of the fistula was achieved.
  
  
  RESULTS
  Ten patients (8 male) with highly recurrent and complex fistulae were treated (mean age: 49 years, range: 28-76 years). Seven cases were non-Crohn's fistulae, and three were Crohn's-associated fistulae. Previous surgical attempts ranged from 3 to 12. Two patients presented with preoperative incontinence (Wexner scores of 12 and 13 points). After the intervention, six patients showed clinical response on the 8(th) postoperative week, with a complete cessation of suppuration from the fistula. Three patients presented a partial response, with an evident decrease in suppuration. A year later, six patients (60%) remained healed, with complete reepithelization of the external opening. Postoperative Wexner Scores were 0 in six cases. The two patients with previous incontinence improved their scores from 12 to 8 points and from 13 to 5 points. No adverse reactions or complications related to stem-cell therapy were reported during the study period.
  
  
  CONCLUSIONS
  Stem cells are safe and useful for treating anal fistulae. Healing can be achieved in severe cases, sparing fecal incontinence risk, and improving previous scoring.
authors: Damian Garcia-Olmo, Hector Guadalajara, Maria Dolores Herreros, Mariano Garcia-Arranz, Hospital Fundación Jimenez Díaz, IIS-FJD, 28040 Madrid, Spain.
authors: Damian
authors: D
authors: Garcia-Olmo
authors: Damian Garcia-Olmo, Hector Guadalajara, Maria Dolores Herreros, Mariano Garcia-Arranz, Hospital Fundación Jimenez Díaz, IIS-FJD, 28040 Madrid, Spain.
authors: Hector
authors: H
authors: Guadalajara
authors: Damian Garcia-Olmo, Hector Guadalajara, Maria Dolores Herreros, Mariano Garcia-Arranz, Hospital Fundación Jimenez Díaz, IIS-FJD, 28040 Madrid, Spain.
authors: Ines
authors: I
authors: Rubio-Perez
authors: Damian Garcia-Olmo, Hector Guadalajara, Maria Dolores Herreros, Mariano Garcia-Arranz, Hospital Fundación Jimenez Díaz, IIS-FJD, 28040 Madrid, Spain.
authors: Maria Dolores
authors: MD
authors: Herreros
authors: Damian Garcia-Olmo, Hector Guadalajara, Maria Dolores Herreros, Mariano Garcia-Arranz, Hospital Fundación Jimenez Díaz, IIS-FJD, 28040 Madrid, Spain.
authors: Paloma
authors: P
authors: de-la-Quintana
authors: Damian Garcia-Olmo, Hector Guadalajara, Maria Dolores Herreros, Mariano Garcia-Arranz, Hospital Fundación Jimenez Díaz, IIS-FJD, 28040 Madrid, Spain.
authors: Mariano
authors: M
authors: Garcia-Arranz
mesh_terms: D000273:Adipose Tissue / Q000166:cytology*; D000328:Adult; D000368:Aged; D002478:Cells, Cultured; D057176:Compassionate Use Trials; D003424:Crohn Disease / Q000150:complications; D005242:Fecal Incontinence / Q000209:etiology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012003:Rectal Fistula / Q000175:diagnosis / Q000209:etiology / Q000601:surgery*; D012008:Recurrence; D012086:Reoperation; D012720:Severity of Illness Index; D033581:Stem Cell Transplantation / Q000009:adverse effects / Q000379:methods; D013997:Time Factors; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D014945:Wound Healing
keywords: Adipose-derived stem cells; Cell therapy; Compassionate use; Crohn’s disease; Fistula-in-ano