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.
Original language | English (US) |
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Pages (from-to) | 59-62.e2 |
Journal | Gastroenterology |
Volume | 153 |
Issue number | 1 |
DOIs | |
State | Published - Jul 2017 |
Keywords
- Cell Therapy
- Clinical Trial
- IBD
- STOMP Trial
ASJC Scopus subject areas
- Hepatology
- Gastroenterology