title: Autologous Mesenchymal Stem Cells, Applied in a Bioabsorbable Matrix, for Treatment of Perianal Fistulas in Patients With Crohn's Disease.
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.
authors.affiliation: Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota. Electronic address: dietz.allan@mayo.edu.
authors.forename: Allan B
authors.initials: AB
authors.lastname: Dietz
authors.affiliation: Department of Colon and Rectal Surgery, Mayo Clinic, Rochester, Minnesota.
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Dozois
authors.affiliation: Department of Radiology, Mayo Clinic, Rochester, Minnesota.
authors.forename: Joel G
authors.initials: JG
authors.lastname: Fletcher
authors.affiliation: Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota.
authors.forename: Greg W
authors.initials: GW
authors.lastname: Butler
authors.affiliation: Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota.
authors.forename: Darcie
authors.initials: D
authors.lastname: Radel
authors.affiliation: Department of Colon and Rectal Surgery, Mayo Clinic, Rochester, Minnesota.
authors.forename: Amy L
authors.initials: AL
authors.lastname: Lightner
authors.affiliation: Division of Gastroenterology and Liver Disease, Case Western Reserve University School of Medicine, Cleveland, Ohio.
authors.forename: Maneesh
authors.initials: M
authors.lastname: Dave
authors.affiliation: Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.
authors.forename: Jessica
authors.initials: J
authors.lastname: Friton
authors.affiliation: Department of Biomedical Statistics and Information, Mayo Clinic, Rochester, Minnesota.
authors.forename: Asha
authors.initials: A
authors.lastname: Nair
authors.affiliation: Department of Orthopedic Surgery, Mayo Clinic, Rochester, Minnesota.
authors.forename: Emily T
authors.initials: ET
authors.lastname: Camilleri
authors.affiliation: Department of Orthopedic Surgery, Mayo Clinic, Rochester, Minnesota.
authors.forename: Amel
authors.initials: A
authors.lastname: Dudakovic
authors.affiliation: Department of Orthopedic Surgery, Mayo Clinic, Rochester, Minnesota.
authors.forename: Andre J
authors.initials: AJ
authors.lastname: van Wijnen
authors.affiliation: Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota. Electronic address: faubion.william@mayo.edu.
authors.forename: William A
authors.initials: WA
authors.lastname: Faubion
mesh_terms: D020341:Absorbable Implants / Q000009:adverse effects; D000293:Adolescent; D000328:Adult; D003424:Crohn Disease / Q000150:complications*; D017577:Cutaneous Fistula / Q000209:etiology / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D045164:Mesenchymal Stem Cell Transplantation / Q000009:adverse effects; D008875:Middle Aged; D012003:Rectal Fistula / Q000209:etiology / Q000628:therapy*; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D014945:Wound Healing; D055815:Young Adult
keywords: Cell Therapy; Clinical Trial; IBD; STOMP Trial