Efficacy of cx601 (darvadstrocel) for the treatment of perianal fistulizing Crohn’s disease—A prospective nationwide multicenter cohort study
Summary Background The use of mesenchymal stem cells is considered a novel and promising therapeutic option for patients with perianal fistulizing Crohn’s disease; however, data on its clinical application remain scarce. This multicenter nationwide study aimed to assess the clinical efficacy of mese...
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Published in | Wiener Klinische Wochenschrift Vol. 136; no. 9-10; pp. 289 - 294 |
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Main Authors | , , , , , , , |
Format | Journal Article |
Language | English |
Published |
Vienna
Springer Vienna
01.05.2024
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Subjects | |
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Abstract | Summary
Background
The use of mesenchymal stem cells is considered a novel and promising therapeutic option for patients with perianal fistulizing Crohn’s disease; however, data on its clinical application remain scarce. This multicenter nationwide study aimed to assess the clinical efficacy of mesenchymal stem cells in closing complex anal fistulas.
Methods
In this study 14 Crohn’s disease patients (3 males, 11 females) with complex anal fistulas treated in 3 tertiary hospitals in Austria were included between October 2018 and April 2021.
Injection of 120 million allogeneic expanded adipose-derived mesenchymal stem cells (Cx601—darvadstrocel) was performed in each patient. Closure of the external fistula opening without secretion by external manual compression was defined as treatment success.
Results
The median age of the patient population at the time of surgery was 32 years (range 26–53 years) with a median body mass index of 21.7 kg/m
2
(range 16.7–26.6 kg/m
2
). Of the patients 12 (86%) received monoclonal antibodies (infliximab, adalimumab, ustekinumab, vedolizumab) at the time of surgery.
The median number of complex fistulas was 1.4 (range 1–2), The median operative time was 20 min (range 6–50 min) with no perioperative complications.
After a median follow-up of 92 weeks, we found successful fistula closure in 57.1% (
n
= 8) of treated patients. The perianal disease activity index did not improve significantly from initially 7 to a median of 6 after 52 weeks (
p
= 0.495).
Conclusion
Darvadstrocel is a safe, minimally invasive surgical technique without significant perioperative complications. Clinical success can be expected in about half of the treated patients. |
---|---|
AbstractList | Summary
Background
The use of mesenchymal stem cells is considered a novel and promising therapeutic option for patients with perianal fistulizing Crohn’s disease; however, data on its clinical application remain scarce. This multicenter nationwide study aimed to assess the clinical efficacy of mesenchymal stem cells in closing complex anal fistulas.
Methods
In this study 14 Crohn’s disease patients (3 males, 11 females) with complex anal fistulas treated in 3 tertiary hospitals in Austria were included between October 2018 and April 2021.
Injection of 120 million allogeneic expanded adipose-derived mesenchymal stem cells (Cx601—darvadstrocel) was performed in each patient. Closure of the external fistula opening without secretion by external manual compression was defined as treatment success.
Results
The median age of the patient population at the time of surgery was 32 years (range 26–53 years) with a median body mass index of 21.7 kg/m
2
(range 16.7–26.6 kg/m
2
). Of the patients 12 (86%) received monoclonal antibodies (infliximab, adalimumab, ustekinumab, vedolizumab) at the time of surgery.
The median number of complex fistulas was 1.4 (range 1–2), The median operative time was 20 min (range 6–50 min) with no perioperative complications.
After a median follow-up of 92 weeks, we found successful fistula closure in 57.1% (
n
= 8) of treated patients. The perianal disease activity index did not improve significantly from initially 7 to a median of 6 after 52 weeks (
p
= 0.495).
Conclusion
Darvadstrocel is a safe, minimally invasive surgical technique without significant perioperative complications. Clinical success can be expected in about half of the treated patients. The use of mesenchymal stem cells is considered a novel and promising therapeutic option for patients with perianal fistulizing Crohn's disease; however, data on its clinical application remain scarce. This multicenter nationwide study aimed to assess the clinical efficacy of mesenchymal stem cells in closing complex anal fistulas.BACKGROUNDThe use of mesenchymal stem cells is considered a novel and promising therapeutic option for patients with perianal fistulizing Crohn's disease; however, data on its clinical application remain scarce. This multicenter nationwide study aimed to assess the clinical efficacy of mesenchymal stem cells in closing complex anal fistulas.In this study 14 Crohn's disease patients (3 males, 11 females) with complex anal fistulas treated in 3 tertiary hospitals in Austria were included between October 2018 and April 2021. Injection of 120 million allogeneic expanded adipose-derived mesenchymal stem cells (Cx601-darvadstrocel) was performed in each patient. Closure of the external fistula opening without secretion by external manual compression was defined as treatment success.METHODSIn this study 14 Crohn's disease patients (3 males, 11 females) with complex anal fistulas treated in 3 tertiary hospitals in Austria were included between October 2018 and April 2021. Injection of 120 million allogeneic expanded adipose-derived mesenchymal stem cells (Cx601-darvadstrocel) was performed in each patient. Closure of the external fistula opening without secretion by external manual compression was defined as treatment success.The median age of the patient population at the time of surgery was 32 years (range 26-53 years) with a median body mass index of 21.7 kg/m2 (range 16.7-26.6 kg/m2). Of the patients 12 (86%) received monoclonal antibodies (infliximab, adalimumab, ustekinumab, vedolizumab) at the time of surgery. The median number of complex fistulas was 1.4 (range 1-2), The median operative time was 20 min (range 6-50 min) with no perioperative complications. After a median follow-up of 92 weeks, we found successful fistula closure in 57.1% (n = 8) of treated patients. The perianal disease activity index did not improve significantly from initially 7 to a median of 6 after 52 weeks (p = 0.495).RESULTSThe median age of the patient population at the time of surgery was 32 years (range 26-53 years) with a median body mass index of 21.7 kg/m2 (range 16.7-26.6 kg/m2). Of the patients 12 (86%) received monoclonal antibodies (infliximab, adalimumab, ustekinumab, vedolizumab) at the time of surgery. The median number of complex fistulas was 1.4 (range 1-2), The median operative time was 20 min (range 6-50 min) with no perioperative complications. After a median follow-up of 92 weeks, we found successful fistula closure in 57.1% (n = 8) of treated patients. The perianal disease activity index did not improve significantly from initially 7 to a median of 6 after 52 weeks (p = 0.495).Darvadstrocel is a safe, minimally invasive surgical technique without significant perioperative complications. Clinical success can be expected in about half of the treated patients.CONCLUSIONDarvadstrocel is a safe, minimally invasive surgical technique without significant perioperative complications. Clinical success can be expected in about half of the treated patients. The use of mesenchymal stem cells is considered a novel and promising therapeutic option for patients with perianal fistulizing Crohn's disease; however, data on its clinical application remain scarce. This multicenter nationwide study aimed to assess the clinical efficacy of mesenchymal stem cells in closing complex anal fistulas. In this study 14 Crohn's disease patients (3 males, 11 females) with complex anal fistulas treated in 3 tertiary hospitals in Austria were included between October 2018 and April 2021. Injection of 120 million allogeneic expanded adipose-derived mesenchymal stem cells (Cx601-darvadstrocel) was performed in each patient. Closure of the external fistula opening without secretion by external manual compression was defined as treatment success. The median age of the patient population at the time of surgery was 32 years (range 26-53 years) with a median body mass index of 21.7 kg/m (range 16.7-26.6 kg/m ). Of the patients 12 (86%) received monoclonal antibodies (infliximab, adalimumab, ustekinumab, vedolizumab) at the time of surgery. The median number of complex fistulas was 1.4 (range 1-2), The median operative time was 20 min (range 6-50 min) with no perioperative complications. After a median follow-up of 92 weeks, we found successful fistula closure in 57.1% (n = 8) of treated patients. The perianal disease activity index did not improve significantly from initially 7 to a median of 6 after 52 weeks (p = 0.495). Darvadstrocel is a safe, minimally invasive surgical technique without significant perioperative complications. Clinical success can be expected in about half of the treated patients. |
Author | Pramhas, Michael Scharitzer, Martina Harpain, Felix Riss, Stefan Widmann, Kerstin Melanie Stift, Anton Czipin, Sascha Dawoud, Christopher |
Author_xml | – sequence: 1 givenname: Christopher orcidid: 0000-0003-1432-2804 surname: Dawoud fullname: Dawoud, Christopher organization: Department of General Surgery, Division of Visceral Surgery, Medical University Vienna – sequence: 2 givenname: Kerstin Melanie surname: Widmann fullname: Widmann, Kerstin Melanie organization: Department of General Surgery, Division of Visceral Surgery, Medical University Vienna – sequence: 3 givenname: Sascha surname: Czipin fullname: Czipin, Sascha organization: Department of Visceral, Transplant and Thoracic Surgery, Centre for Operative Medicine, Medical University of Innsbruck – sequence: 4 givenname: Michael surname: Pramhas fullname: Pramhas, Michael organization: First Surgical Department, Klinik Landstraße – sequence: 5 givenname: Martina surname: Scharitzer fullname: Scharitzer, Martina organization: Department of Biomedical Imaging and Image-Guided Therapy, Medical University Vienna – sequence: 6 givenname: Anton surname: Stift fullname: Stift, Anton organization: Department of General Surgery, Division of Visceral Surgery, Medical University Vienna – sequence: 7 givenname: Felix surname: Harpain fullname: Harpain, Felix organization: Department of General Surgery, Division of Visceral Surgery, Medical University Vienna – sequence: 8 givenname: Stefan surname: Riss fullname: Riss, Stefan email: stefan.riss@meduniwien.ac.at organization: Department of General Surgery, Division of Visceral Surgery, Medical University Vienna |
BackLink | https://www.ncbi.nlm.nih.gov/pubmed/37823920$$D View this record in MEDLINE/PubMed |
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Keywords | Fistula remission Stem cell therapy Perianal fistulizing Crohn’s disease Anal fistula Complex fistula |
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The use of mesenchymal stem cells is considered a novel and promising therapeutic option for patients with perianal fistulizing Crohn’s... The use of mesenchymal stem cells is considered a novel and promising therapeutic option for patients with perianal fistulizing Crohn's disease; however, data... The use of mesenchymal stem cells is considered a novel and promising therapeutic option for patients with perianal fistulizing Crohn's disease; however, data... |
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SubjectTerms | Adult Austria Cohort Studies Crohn Disease - complications Endocrinology Female Gastroenterology Humans Internal Medicine Male Medicine Medicine & Public Health Mesenchymal Stem Cell Transplantation Middle Aged Original Original Article Pneumology/Respiratory System Prospective Studies Rectal Fistula - drug therapy Rectal Fistula - etiology Rectal Fistula - therapy Treatment Outcome |
Title | Efficacy of cx601 (darvadstrocel) for the treatment of perianal fistulizing Crohn’s disease—A prospective nationwide multicenter cohort study |
URI | https://link.springer.com/article/10.1007/s00508-023-02283-4 https://www.ncbi.nlm.nih.gov/pubmed/37823920 https://www.proquest.com/docview/2876639184/abstract/ https://pubmed.ncbi.nlm.nih.gov/PMC11078846 |
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