Long-term Efficacy and Safety of Stem Cell Therapy (Cx601) for Complex Perianal Fistulas in Patients With Crohn's Disease
- Panes J.
- Garcia-Olmo D.
- Van Assche G.
- Colombel J. F.
- Reinisch W.
- Baumgart D. C.
- Dignass A.
- Nachury M.
- Ferrante M.
- Kazemi-Shirazi L.
- Grimaud J. C.
- de la Portilla F.
- Goldin E.
- Richard M. P.
- Diez M. C.
- Tagarro I.
- Leselbaum A.
- Danese S.
- Stift A.
- Tschmelitsch J.
- Mrak K.
- Tilg H.
- Kroberger I.
- D'Hoore A.
- De Looze D.
- Baert F.
- Pattyn P.
- Zerbib P.
- Zerbib F.
- Viennot S.
- Dupas J. -L.
- Orsoni P. -C.
- Hebuterne X.
- Rahili A.
- Allez M.
- Panis Y.
- Reinshagen M.
- Scherer R.
- Sturm A.
- Kruis W.
- Duek D. -S.
- Waterman M.
- Lahat-Zok A.
- Zmora O.
- Tulchinsky H.
- Edden Y.
- Spinelli A.
- Annese V.
- Angriman I.
- Riegler G.
- Selvaggi F.
- Oldenburg B.
- Gilissen L.
- Van Montfort G.
- Lowenberg M.
- Bemelman A. W.
- Almenara R.
- Martin Arranz M. D.
- Garcia-Arranz M.
- Perez Gisbert J.
- Palasi R.
- Samso C. T.
- Herrera Justiniano J. M.
- Rada R.
- Butron M. T.
- Lopez D. C.
- Lopez-Sanroman A.
- Hinojosa de Val J.
- Solana A.
- Gonzalez Argente F. X.
- PASTORE, Concetta
- Guadalajara H.
DOIAbstract
Background & Aims: Therapies for perianal fistulas in patients with Crohn's disease are often ineffective in producing long-term healing. We performed a randomized placebo-controlled trial to determine the long-term efficacy and safety of a single local administration of allogeneic expanded adipose-derived stem cells (Cx601) in patients with Crohn's disease and perianal fistulas. Methods: We performed a double-blind study at 49 hospitals in Europe and Israel, comprising 212 patients with Crohn's disease and treatment-refractory, draining, complex perianal fistulas. Patients were randomly assigned (1:1) to groups given a single local injection of 120 million Cx601 cells or placebo (control), in addition to the standard of care. Efficacy ...
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