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

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 associat...

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Veröffentlicht in:Gastroenterology (New York, N.Y. 1943) Jg. 153; H. 1; S. 59
Hauptverfasser: Dietz, Allan B, Dozois, Eric J, Fletcher, Joel G, Butler, Greg W, Radel, Darcie, Lightner, Amy L, Dave, Maneesh, Friton, Jessica, Nair, Asha, Camilleri, Emily T, Dudakovic, Amel, van Wijnen, Andre J, Faubion, William A
Format: Journal Article
Sprache:Englisch
Veröffentlicht: United States 01.07.2017
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ISSN:1528-0012, 1528-0012
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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.
AbstractList 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.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.
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.
Author Fletcher, Joel G
Dave, Maneesh
Butler, Greg W
Lightner, Amy L
Dietz, Allan B
Faubion, William A
Friton, Jessica
Dozois, Eric J
Camilleri, Emily T
Radel, Darcie
Nair, Asha
Dudakovic, Amel
van Wijnen, Andre J
Author_xml – sequence: 1
  givenname: Allan B
  surname: Dietz
  fullname: Dietz, Allan B
  email: dietz.allan@mayo.edu
  organization: Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota. Electronic address: dietz.allan@mayo.edu
– sequence: 2
  givenname: Eric J
  surname: Dozois
  fullname: Dozois, Eric J
  organization: Department of Colon and Rectal Surgery, Mayo Clinic, Rochester, Minnesota
– sequence: 3
  givenname: Joel G
  surname: Fletcher
  fullname: Fletcher, Joel G
  organization: Department of Radiology, Mayo Clinic, Rochester, Minnesota
– sequence: 4
  givenname: Greg W
  surname: Butler
  fullname: Butler, Greg W
  organization: Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota
– sequence: 5
  givenname: Darcie
  surname: Radel
  fullname: Radel, Darcie
  organization: Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota
– sequence: 6
  givenname: Amy L
  surname: Lightner
  fullname: Lightner, Amy L
  organization: Department of Colon and Rectal Surgery, Mayo Clinic, Rochester, Minnesota
– sequence: 7
  givenname: Maneesh
  surname: Dave
  fullname: Dave, Maneesh
  organization: Division of Gastroenterology and Liver Disease, Case Western Reserve University School of Medicine, Cleveland, Ohio
– sequence: 8
  givenname: Jessica
  surname: Friton
  fullname: Friton, Jessica
  organization: Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota
– sequence: 9
  givenname: Asha
  surname: Nair
  fullname: Nair, Asha
  organization: Department of Biomedical Statistics and Information, Mayo Clinic, Rochester, Minnesota
– sequence: 10
  givenname: Emily T
  surname: Camilleri
  fullname: Camilleri, Emily T
  organization: Department of Orthopedic Surgery, Mayo Clinic, Rochester, Minnesota
– sequence: 11
  givenname: Amel
  surname: Dudakovic
  fullname: Dudakovic, Amel
  organization: Department of Orthopedic Surgery, Mayo Clinic, Rochester, Minnesota
– sequence: 12
  givenname: Andre J
  surname: van Wijnen
  fullname: van Wijnen, Andre J
  organization: Department of Orthopedic Surgery, Mayo Clinic, Rochester, Minnesota
– sequence: 13
  givenname: William A
  surname: Faubion
  fullname: Faubion, William A
  email: faubion.william@mayo.edu
  organization: Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota. Electronic address: faubion.william@mayo.edu
BackLink https://www.ncbi.nlm.nih.gov/pubmed/28400193$$D View this record in MEDLINE/PubMed
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ContentType Journal Article
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Snippet In patients with Crohn's disease, perianal fistulas recur frequently, causing substantial morbidity. We performed a 12-patient, 6-month, phase 1 trial to...
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StartPage 59
SubjectTerms 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
Title Autologous Mesenchymal Stem Cells, Applied in a Bioabsorbable Matrix, for Treatment of Perianal Fistulas in Patients With Crohn's Disease
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