For darvadstrocel (perianal fistulae): fistula healing (defined as complete absence of drainage and closure on examination) is achieved in 50–60% at 24 weeks, with sustained healing in 40–50% at 1 year in published trials. For systemic MSC induction: clinical remission (Crohn's Disease Activity Index <150 or Mayo score <3) is achieved in 40–55% at 8–12 weeks. Mucosal healing (endoscopic ulcer resolution) accompanies remission in ~50% of responders. Combined remission (clinical + endoscopic) is less frequent (~30–40%). Responders tend to be those with moderate disease and fewer prior biologic exposures; non-responders and biologic-refractory disease show lower healing rates.
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.
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