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Skeletal muscle–derived cell implantation for the treatment of fecal incontinence : a randomized, placebo-controlled study

Frudinger, Andrea (författare)
Department of Obstetrics and Gynaecology, Medical University of Graz, Graz, Austria,Med Univ Graz, Dept Obstet & Gynaecol, Graz, Austria.;Med Univ Graz, Dept Obstet & Gynaecol, Div Gynaecol, Auenbruggerpl 14, A-8036 Graz, Austria
Gauruder-Burmester, Annett (författare)
Interdisciplinary Pelvic Floor Center, Berlin, Germany,Interdisciplinary Pelv Floor Ctr, Berlin, Germany
Graf, Wilhelm (författare)
Uppsala universitet,Gastrointestinalkirurgi,Akad Sjukhuset, Dept Surg, Uppsala, Sweden
visa fler...
Lehmann, Jan-Peter (författare)
Department of Surgery, Östersunds Hospital, Östersund, Sweden,Östersunds Hosp, Dept Surg, Östersund, Sweden
Gunnarsson, Ulf (författare)
Umeå universitet,Kirurgi,Umeå Univ, Dept Surg & Perioperat Sci, Umeå, Sweden
Mihov, Minko (författare)
Medical Center Unimed EOOD, Sevlievo, Bulgaria,Med Ctr Unimed EOOD, Sevlievo, Bulgaria
Ihnát, Peter (författare)
Department of Surgical Studies, Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic,Univ Ostrava, Fac Med, Dept Surg Studies, Ostrava, Czech Republic
Kosorok, Pavle (författare)
Department of Proctology, Iatros Medical Centre, Ljubljana, Slovenia,Iatros Med Ctr, Dept Proctol, Ljubljana, Slovenia
Orhalmi, Julius (författare)
Department of Surgery, University Hospital Hradec Kralove, Faculty of Medicine in Hradec Kralove, Charles University, Prague, Czech Republic,Charles Univ Prague, Univ Hosp Hradec Kralove, Fac Med Hradec Kralove, Dept Surg, Prague, Czech Republic
Slauf, Petr (författare)
Surgical Clinic 1, Faculty of Medicine, University Hospital Bulovka, Charles University, Prague, Czech Republic,Charles Univ Prague, Univ Hosp Bulovka, Fac Med, Surg Clin 1, Prague, Czech Republic
Emmanuel, Anton (författare)
Gastrointestinal Physiology Unit, University College Hospital, London, United Kingdom,Univ Coll Hosp, Gastrointestinal Physiol Unit, London, England
Hristov, Vladislav (författare)
Pirogov Hospital, Sofia, Bulgaria,Pirogov Hosp, Sofia, Bulgaria
Jungwirthova, Anna (författare)
Department of Gastroenterology, St. Anna Clinic, Prague, Czech Republic,St Anna Clin, Dept Gastroenterol, Prague, Czech Republic
Lehur, Paul-Antoine (författare)
Clinique de Chirurgie Digestive et Endocrinienne, Institut des Maladies de l'Appareil Digestif, University Hospital of Nantes, Nantes, France,Univ Hosp Nantes, Inst Malad Appareil Digest, Clin Chirurg Digest & Endocrinienne, Nantes, France
Müller, Andreas (författare)
GastroZentrum Hirslanden, Klinik Hirslanden, Zürich, Switzerland
Amort, Melanie (författare)
Innovacell AG, Innsbruck, Austria
Marksteiner, Rainer (författare)
Innovacell AG, Innsbruck, Austria
Thurner, Marco (författare)
Innovacell AG, Innsbruck, Austria
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Department of Obstetrics and Gynaecology, Medical University of Graz, Graz, Austria Med Univ Graz, Dept Obstet & Gynaecol, Graz, Austria;Med Univ Graz, Dept Obstet & Gynaecol, Div Gynaecol, Auenbruggerpl 14, A-8036 Graz, Austria (creator_code:org_t)
Elsevier, 2023
2023
Engelska.
Ingår i: Clinical Gastroenterology and Hepatology. - : Elsevier. - 1542-3565 .- 1542-7714. ; 21:2, s. 476-486.e8
  • Tidskriftsartikel (refereegranskat)
Abstract Ämnesord
Stäng  
  • Background and Aims: Fecal incontinence (FI) improvement following injection of autologous skeletal muscle–derived cells has been previously suggested. This study aimed to test the efficacy and safety of said cells through a multicenter, placebo-controlled study, to determine an appropriate cell dose, and to delineate the target patient population that can most benefit from cell therapy.Methods: Patients experiencing FI for at least 6 months were randomized to receive a cell-free medium or low or high dose of cells. All patients received pelvic floor electrical stimulation before and after treatment. Incontinence episode frequency (IEF), FI quality of life, FI burden assessed on a visual analog scale, Wexner score, and parameters reflecting anorectal physiological function were all assessed for up to 12 months.Results: Cell therapy improved IEF, FI quality of life, and FI burden, reaching a preset level of statistical significance in IEF change compared with the control treatment. Post hoc exploratory analyses indicated that patients with limited FI duration and high IEF at baseline are most responsive to cells. Effects prevailed or increased in the high cell count group from 6 to 12 months but plateaued or diminished in the low cell count and control groups. Most physiological parameters remained unaltered. No unexpected adverse events were observed. Conclusions: Injection of a high dose of autologous skeletal muscle–derived cells followed by electrical stimulation significantly improved FI, particularly in patients with limited FI duration and high IEF at baseline, and could become a valuable tool for treatment of FI, subject to confirmatory phase 3 trial(s). (ClinicalTrialRegister.eu; EudraCT Number: 2010-021463-32).

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Gastroenterologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Gastroenterology and Hepatology (hsv//eng)

Nyckelord

Cell Therapy
Fecal incontinence
Myogenic Progenitor Cells
Regenerative Medicine
Skeletal Muscle–Derived Cells
Surgery
kirurgi

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