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 |
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01.07.2017
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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. |
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| 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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| 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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