Autologous Mesenchymal Stem Cells, Applied in a Bioabsorbable Matrix, for Treatment of Perianal Fistulas in Patients With Crohn's Disease

Gastroenterology. 2017 Jul;153(1):59-62.e2. doi: 10.1053/j.gastro.2017.04.001. Epub 2017 Apr 9.

Abstract

In patients with Crohn's disease, perianal fistulas recur frequently, causing substantial morbidity. We performed a 12-patient, 6-month, phase 1 trial to determine whether autologous mesenchymal stem cells, applied in a bioabsorbable matrix, can heal the fistula. Fistula repair was not associated with any serious adverse events related to mesenchymal stem cells or plug placement. At 6 months, 10 of 12 patients (83%) had complete clinical healing and radiographic markers of response. We found placement of mesenchymal stem cell-coated matrix fistula plugs in 12 patients with chronic perianal fistulas to be safe and lead to clinical healing and radiographic response in 10 patients. ClinicalTrials.gov Identifier: NCT01915927.

Keywords: Cell Therapy; Clinical Trial; IBD; STOMP Trial.

Publication types

  • Clinical Trial, Phase I
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Absorbable Implants / adverse effects
  • Adolescent
  • Adult
  • Crohn Disease / complications*
  • Cutaneous Fistula / etiology
  • Cutaneous Fistula / therapy*
  • Female
  • Humans
  • Male
  • Mesenchymal Stem Cell Transplantation* / adverse effects
  • Middle Aged
  • Rectal Fistula / etiology
  • Rectal Fistula / therapy*
  • Transplantation, Autologous
  • Treatment Outcome
  • Wound Healing
  • Young Adult

Associated data

  • ClinicalTrials.gov/NCT01915927