Darvadstrocel application for perianal fistulae is performed under general or regional anaesthesia by colorectal surgeons, requiring 30–60 minutes and same-day discharge; mild anal discomfort and drainage may persist 2–4 weeks post-procedure. Intravenous MSC infusion for induction therapy is outpatient, requiring 30–60 minutes; mild fever or transient abdominal symptoms may occur 24–48 hours post-infusion. No prolonged hospitalisation or surgical recovery is required for either approach. Resumption of normal diet and activities: fistula patients are cautioned against heavy lifting for 2–4 weeks; induction patients resume normal activity within 24–48 hours. Concurrent IBD maintenance therapy (5-ASA, biologics, antibiotics for fistulae) continues uninterrupted.
Darvadstrocel (Alofisel) received EU conditional marketing authorisation in 2018 for complex perianal fistulising Crohn's disease refractory to conventional and biologic therapy. Pivotal trials reported fistula healing (absence of drainage from all treated fistulae) in 50–55% of patients at 24 weeks, versus ~30% in sham controls. This remains the only EU-approved cell therapy for IBD. For systemic induction therapy, published trials of intravenous MSC infusion in active Crohn's or ulcerative colitis report clinical remission in 40–55% at 8–12 weeks, comparable to biologic induction but with longer onset (8–12 weeks versus 2–4 weeks for TNF inhibitors). Mucosal healing (endoscopic resolution of ulceration) is less frequently achieved than symptom remission. Long-term maintenance data are sparse; re-induction or re-infusion protocols are emerging.
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Medically reviewed by StemCellAtlas’s editorial team with Dr Polina Krasenova (Haematologist · Clinical Haematology & Integrative Oncology · 15+ yrs cell therapy) of partner clinic Stem Plus (Sofia), against ISSCR, FDA & EMA guidance. Educational information, not medical advice; figures indicative.
Medicina rigenerativa certificata GMP nel cuore dell'UE — da 3.000–8.000 €, una frazione dei prezzi USA o tedeschi. Protocolli personalizzati per pazienti da oltre 50 Paesi.
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