An extensive paper has been updated recently in January 2024 on Takeda's Darvadstrocel (aka Alofisel® for the treatment of Crohn’s Perianal Fistulas showing 61% of patients demonstrated clinical remission .... Mesoblast via TiGenix, which was acquired by Takeda in 2018, has a patent license for Alofisel® - Mesoblast has so far received over €20 million to date for this license deal in the EU and Japan so perhaps it's time to do a USA deal and throw Remestemcel-L into the package for this indication ?
https://www.sec.gov/Archives/edgar/data/1345099/000156459018022521/meso-ex421_530.htm
PATENT LICENSE AND SETTLEMENT AGREEMENT
https://onlinelibrary.wiley.com/doi/full/10.1111/codi.16830?campaign=woletoc
https://onlinelibrary.wiley.com/doi/epdf/10.1111/codi.16830
Volume26, Issue1
January 2024
Mesenchymal stem cell therapy for Crohn's perianal fistula—a real-world experience
Results
Thirty-three patients with Crohn's disease and complex perianal fistulas were included. Of these, 20 (61%) experienced clinical remission that was maintained for a mean follow-up of 14 (3–32) months. A total of 24 of 33 (73%) experienced at least 3 months of clinical remission, with four later having recurrence (3–12 months). Among the remaining nine patients who did not experience clinical remission, two (6%) had partial remission (such as one of two fistulas closing), two (6%) showed signs of response but not remission, and five (15%) showed no signs of healing. The mean time to maintained clinical remission was 6 weeks (range 2 weeks to 6 months), and there were no severe adverse events.
Conclusion
In this real-world experience, treatment of Crohn's disease complex perianal fistulas with darvadstrocel had a 61% success rate for maintained clinical remission.
I wonder when we are likely to see data from Remestemcel-L's two IBD related trials ? .... the follow up was due anytime from Oct 2023 ? Time to get things done - the supposedly well supported (lol) CR funds won't last forever
https://clinicaltrials.gov/study/NCT04548583?intr=Remestemcel-L&rank=1
Study of Mesenchymal Stem Cells for the Treatment of Medically Refractory Crohn's Colitis
https://clinicaltrials.gov/study/NCT04543994?intr=Remestemcel-L&rank=2
Study of Mesenchymal Stem Cells for the Treatment of Medically Refractory Ulcerative Colitis (UC)
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- Ann: Ulcerative Colitis & Crohns Results Presented at ECCO
Ann: Ulcerative Colitis & Crohns Results Presented at ECCO, page-195
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