Journal
GASTROENTEROLOGY
Volume 153, Issue 1, Pages 59-+Publisher
W B SAUNDERS CO-ELSEVIER INC
DOI: 10.1053/j.gastro.2017.04.001
Keywords
STOMP Trial; IBD; Cell Therapy; Clinical Trial
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Funding
- National Institutes of Health [R01 (R01AI089714)]
- Center of Regenerative Medicine at the Mayo Clinic
- Department of Laboratory Medicine and Pathology
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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 bio-absorbable 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 cellLcoated 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.
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