Allogeneic Bone Marrow-Derived Mesenchymal Stromal Cells Promote Healing of Refractory Perianal Fistulas in Patients With Crohn's Disease

Patients with perianal fistulizing Crohn's disease have a poor prognosis because these lesions do not heal well. We evaluated the effects of local administration of bone marrow-derived mesenchymal stromal cells (MSCs) to these patients from healthy donors in a double-blind, placebo-controlled s...

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Vydáno v:	Gastroenterology (New York, N.Y. 1943) Ročník 149; číslo 4; s. 918 - 27.e6
Hlavní autoři:	Molendijk, Ilse, Bonsing, Bert A, Roelofs, Helene, Peeters, Koen C M J, Wasser, Martin N J M, Dijkstra, Gerard, van der Woude, C Janneke, Duijvestein, Marjolijn, Veenendaal, Roeland A, Zwaginga, Jaap-Jan, Verspaget, Hein W, Fibbe, Willem E, van der Meulen-de Jong, Andrea E, Hommes, Daniel W
Médium:	Journal Article
Jazyk:	angličtina
Vydáno:	United States 01.10.2015
Témata:	Adult Bone Marrow Transplantation - adverse effects Cells, Cultured Crohn Disease - complications Crohn Disease - diagnosis Double-Blind Method Female Humans Magnetic Resonance Imaging Male Mesenchymal Stem Cell Transplantation - adverse effects Middle Aged Netherlands Rectal Fistula - diagnosis Rectal Fistula - etiology Rectal Fistula - surgery Time Factors Transplantation, Homologous Treatment Outcome Wound Healing Young Adult Netherlands Treatment Cell Therapy Inflammatory Bowel Disease Perianal Fistulas
ISSN:	1528-0012
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Abstract	Patients with perianal fistulizing Crohn's disease have a poor prognosis because these lesions do not heal well. We evaluated the effects of local administration of bone marrow-derived mesenchymal stromal cells (MSCs) to these patients from healthy donors in a double-blind, placebo-controlled study. Twenty-one patients with refractory perianal fistulizing Crohn's disease were randomly assigned to groups given injections of 1 × 10(7) (n = 5, group 1), 3 × 10(7) (n = 5, group 2), or 9 × 10(7) (n = 5, group 3) MSCs, or placebo (solution with no cells, n = 6), into the wall of curettaged fistula, around the trimmed and closed internal opening. The primary outcome, fistula healing, was determined by physical examination 6, 12, and 24 weeks later; healing was defined as absence of discharge and <2 cm of fluid collection-the latter determined by magnetic resonance imaging at week 12. All procedures were performed at Leiden University Medical Center, The Netherlands, from June 2012 through July 2014. No adverse events were associated with local injection of any dose of MSCs. Healing at week 6 was observed in 3 patients in group 1 (60.0%), 4 patients in group 2 (80.0%), and 1 patient in group 3 (20.0%), vs 1 patient in the placebo group (16.7%) (P = .08 for group 2 vs placebo). At week 12, healing was observed in 2 patients in group 1 (40.0%), 4 patients in group 2 (80.0%), and 1 patient in group 3 (20.0%), vs 2 patients in the placebo group (33.3%); these effects were maintained until week 24 and even increased to 4 (80.0%) in group 1. At week six, 4 of 9 individual fistulas had healed in group 1 (44.4%), 6 of 7 had healed in group 2 (85.7%), and 2 of 7 had healed in group 3 (28.6%) vs 2 of 9 (22.2%) in the placebo group (P = .04 for group 2 vs placebo). At week twelve, 3 of 9 individual fistulas had healed in group 1 (33.3%), 6 of 7 had healed in group 2 (85.7%), 2 of 7 had healed in group 3 (28.6%), and 3 of 9 had healed in the placebo group (33.3%). These effects were stable through week 24 and even increased to 6 of 9 (66.7%) in group 1 (P = .06 group 2 vs placebo, weeks 12 and 24). Local administration of allogeneic MSCs was not associated with severe adverse events in patients with perianal fistulizing Crohn's disease. Injection of 3 × 10(7) MSCs appeared to promote healing of perianal fistulas. ClinicalTrials.gov ID NCT01144962.
AbstractList	Patients with perianal fistulizing Crohn's disease have a poor prognosis because these lesions do not heal well. We evaluated the effects of local administration of bone marrow-derived mesenchymal stromal cells (MSCs) to these patients from healthy donors in a double-blind, placebo-controlled study. Twenty-one patients with refractory perianal fistulizing Crohn's disease were randomly assigned to groups given injections of 1 × 10(7) (n = 5, group 1), 3 × 10(7) (n = 5, group 2), or 9 × 10(7) (n = 5, group 3) MSCs, or placebo (solution with no cells, n = 6), into the wall of curettaged fistula, around the trimmed and closed internal opening. The primary outcome, fistula healing, was determined by physical examination 6, 12, and 24 weeks later; healing was defined as absence of discharge and <2 cm of fluid collection-the latter determined by magnetic resonance imaging at week 12. All procedures were performed at Leiden University Medical Center, The Netherlands, from June 2012 through July 2014. No adverse events were associated with local injection of any dose of MSCs. Healing at week 6 was observed in 3 patients in group 1 (60.0%), 4 patients in group 2 (80.0%), and 1 patient in group 3 (20.0%), vs 1 patient in the placebo group (16.7%) (P = .08 for group 2 vs placebo). At week 12, healing was observed in 2 patients in group 1 (40.0%), 4 patients in group 2 (80.0%), and 1 patient in group 3 (20.0%), vs 2 patients in the placebo group (33.3%); these effects were maintained until week 24 and even increased to 4 (80.0%) in group 1. At week six, 4 of 9 individual fistulas had healed in group 1 (44.4%), 6 of 7 had healed in group 2 (85.7%), and 2 of 7 had healed in group 3 (28.6%) vs 2 of 9 (22.2%) in the placebo group (P = .04 for group 2 vs placebo). At week twelve, 3 of 9 individual fistulas had healed in group 1 (33.3%), 6 of 7 had healed in group 2 (85.7%), 2 of 7 had healed in group 3 (28.6%), and 3 of 9 had healed in the placebo group (33.3%). These effects were stable through week 24 and even increased to 6 of 9 (66.7%) in group 1 (P = .06 group 2 vs placebo, weeks 12 and 24). Local administration of allogeneic MSCs was not associated with severe adverse events in patients with perianal fistulizing Crohn's disease. Injection of 3 × 10(7) MSCs appeared to promote healing of perianal fistulas. ClinicalTrials.gov ID NCT01144962. BACKGROUND & AIMSPatients with perianal fistulizing Crohn's disease have a poor prognosis because these lesions do not heal well. We evaluated the effects of local administration of bone marrow-derived mesenchymal stromal cells (MSCs) to these patients from healthy donors in a double-blind, placebo-controlled study.METHODSTwenty-one patients with refractory perianal fistulizing Crohn's disease were randomly assigned to groups given injections of 1 × 10(7) (n = 5, group 1), 3 × 10(7) (n = 5, group 2), or 9 × 10(7) (n = 5, group 3) MSCs, or placebo (solution with no cells, n = 6), into the wall of curettaged fistula, around the trimmed and closed internal opening. The primary outcome, fistula healing, was determined by physical examination 6, 12, and 24 weeks later; healing was defined as absence of discharge and <2 cm of fluid collection-the latter determined by magnetic resonance imaging at week 12. All procedures were performed at Leiden University Medical Center, The Netherlands, from June 2012 through July 2014.RESULTSNo adverse events were associated with local injection of any dose of MSCs. Healing at week 6 was observed in 3 patients in group 1 (60.0%), 4 patients in group 2 (80.0%), and 1 patient in group 3 (20.0%), vs 1 patient in the placebo group (16.7%) (P = .08 for group 2 vs placebo). At week 12, healing was observed in 2 patients in group 1 (40.0%), 4 patients in group 2 (80.0%), and 1 patient in group 3 (20.0%), vs 2 patients in the placebo group (33.3%); these effects were maintained until week 24 and even increased to 4 (80.0%) in group 1. At week six, 4 of 9 individual fistulas had healed in group 1 (44.4%), 6 of 7 had healed in group 2 (85.7%), and 2 of 7 had healed in group 3 (28.6%) vs 2 of 9 (22.2%) in the placebo group (P = .04 for group 2 vs placebo). At week twelve, 3 of 9 individual fistulas had healed in group 1 (33.3%), 6 of 7 had healed in group 2 (85.7%), 2 of 7 had healed in group 3 (28.6%), and 3 of 9 had healed in the placebo group (33.3%). These effects were stable through week 24 and even increased to 6 of 9 (66.7%) in group 1 (P = .06 group 2 vs placebo, weeks 12 and 24).CONCLUSIONSLocal administration of allogeneic MSCs was not associated with severe adverse events in patients with perianal fistulizing Crohn's disease. Injection of 3 × 10(7) MSCs appeared to promote healing of perianal fistulas. ClinicalTrials.gov ID NCT01144962.
Author	Roelofs, Helene Hommes, Daniel W Dijkstra, Gerard Verspaget, Hein W Bonsing, Bert A Peeters, Koen C M J van der Meulen-de Jong, Andrea E Veenendaal, Roeland A van der Woude, C Janneke Duijvestein, Marjolijn Wasser, Martin N J M Fibbe, Willem E Molendijk, Ilse Zwaginga, Jaap-Jan
Author_xml	– sequence: 1 givenname: Ilse surname: Molendijk fullname: Molendijk, Ilse organization: Department of Gastroenterology and Hepatology, Leiden University Medical Center, Leiden, The Netherlands – sequence: 2 givenname: Bert A surname: Bonsing fullname: Bonsing, Bert A organization: Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands – sequence: 3 givenname: Helene surname: Roelofs fullname: Roelofs, Helene organization: Department of Immunohematology and Blood Transfusion, Leiden University Medical Center, Leiden, The Netherlands – sequence: 4 givenname: Koen C M J surname: Peeters fullname: Peeters, Koen C M J organization: Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands – sequence: 5 givenname: Martin N J M surname: Wasser fullname: Wasser, Martin N J M organization: Department of Radiology, Leiden University Medical Center, Leiden, The Netherlands – sequence: 6 givenname: Gerard surname: Dijkstra fullname: Dijkstra, Gerard organization: Department Gastroenterology and Hepatology, University Medical Center Groningen, Groningen, The Netherlands – sequence: 7 givenname: C Janneke surname: van der Woude fullname: van der Woude, C Janneke organization: Department of Gastroenterology and Hepatology, Erasmus Medical Center, Rotterdam, The Netherlands – sequence: 8 givenname: Marjolijn surname: Duijvestein fullname: Duijvestein, Marjolijn organization: Department of Gastroenterology and Hepatology, Leiden University Medical Center, Leiden, The Netherlands – sequence: 9 givenname: Roeland A surname: Veenendaal fullname: Veenendaal, Roeland A organization: Department of Gastroenterology and Hepatology, Leiden University Medical Center, Leiden, The Netherlands – sequence: 10 givenname: Jaap-Jan surname: Zwaginga fullname: Zwaginga, Jaap-Jan organization: Department of Immunohematology and Blood Transfusion, Leiden University Medical Center, Leiden, The Netherlands; The Jon J van Rood Center for Clinical Transfusion Research, Sanquin-Leiden University Medical Center, Leiden, The Netherlands – sequence: 11 givenname: Hein W surname: Verspaget fullname: Verspaget, Hein W organization: Department of Gastroenterology and Hepatology, Leiden University Medical Center, Leiden, The Netherlands – sequence: 12 givenname: Willem E surname: Fibbe fullname: Fibbe, Willem E organization: Department of Immunohematology and Blood Transfusion, Leiden University Medical Center, Leiden, The Netherlands – sequence: 13 givenname: Andrea E surname: van der Meulen-de Jong fullname: van der Meulen-de Jong, Andrea E email: ae.meulen@lumc.nl organization: Department of Gastroenterology and Hepatology, Leiden University Medical Center, Leiden, The Netherlands. Electronic address: ae.meulen@lumc.nl – sequence: 14 givenname: Daniel W surname: Hommes fullname: Hommes, Daniel W organization: Department of Gastroenterology and Hepatology, Leiden University Medical Center, Leiden, The Netherlands; Division of Digestive Diseases, University of California Los Angeles, Los Angeles, California
BackLink	https://www.ncbi.nlm.nih.gov/pubmed/26116801$$D View this record in MEDLINE/PubMed
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Keywords	Treatment Cell Therapy Inflammatory Bowel Disease Perianal Fistulas
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Snippet	Patients with perianal fistulizing Crohn's disease have a poor prognosis because these lesions do not heal well. We evaluated the effects of local... BACKGROUND & AIMSPatients with perianal fistulizing Crohn's disease have a poor prognosis because these lesions do not heal well. We evaluated the effects of...
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SubjectTerms	Adult Bone Marrow Transplantation - adverse effects Cells, Cultured Crohn Disease - complications Crohn Disease - diagnosis Double-Blind Method Female Humans Magnetic Resonance Imaging Male Mesenchymal Stem Cell Transplantation - adverse effects Middle Aged Netherlands Rectal Fistula - diagnosis Rectal Fistula - etiology Rectal Fistula - surgery Time Factors Transplantation, Homologous Treatment Outcome Wound Healing Young Adult
Title	Allogeneic Bone Marrow-Derived Mesenchymal Stromal Cells Promote Healing of Refractory Perianal Fistulas in Patients With Crohn's Disease
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