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Cell Therapy News/Articles, page-14353

  1. Bazsa
    3,882 Posts.
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    17/10/22
    12:03
    Post #: 64232858
    About CDAI score
    https://www.sciencedirect.com/topics/medicine-and-dentistry/crohns-disease-activity-index


    Also found this site that explaines some of the history of protocol 603.

    https://www.sps.nhs.uk/medicines/remestemcel-l/

    Epidemiology
    In 2010, there were around 79,115 adults in England with Crohn’s disease, of whom ~50% (39,557) are resistant or intolerant to conventional therapies [7].
    Indication
    Treatment refractory, moderate to severe Crohn's disease in adults - second-line
    Methods of administration/route
    Intravenous infusion

    Trial or other data

    Feb 21 · PIb/PIIa trial (NCT04548583) is recruiting [14].
    Dec 20 · No trial results seem to be have been announced for the completed PIII trials [11-13].
    Oct 20 · The Cleveland Clinic in collaboration with Mesoblast initiate a PIb/IIa trial to evaluate the safety and efficacy of remestemcel-L in patients with refractory Crohn ´s disease (CCF-Stem-Cells-IBD004; NCT04548583). The randomised, placebo-controlled trial intends to enrol 24 patients in the US. Primary outcome is safety. The trial is due to complete Oct 23 [12].
    Sep 14 · PIII Osiris 603 trial (NCT00482092) and PIII Osiris 611 trial (NCT01233960) completed. PIII Osiris 603 trial (NCT00543374) completed in Apr 11. Another PIII trial, Osiris 610, was discontinued to remove the potential for bias in Osiris 603 [12].
    Oct 13 · Osiris has entered into an agreement with a subsidiary of Mesoblast Limited for the sale of Osiris’ culture-expanded mesenchymal stem cell business, including Prochymal [6]
    Nov 10 · NCT01233960 is a multicenter, open-label study (protocol 611) to evaluate the safety of Prochymal® (remestemcel-l) in 120 subjects who have received previous remestemcel-l induction treatment (in Protocol 603) for treatment-refractory moderate-to-severe Crohn´s disease. The primary outcome is disease remission at 180 days after first infusion in Protocol 603 (CDAI ≤150 and increase in IBDQ). The study started Sep 10 and is due to complete Jan 13 [4].
    Apr 10 · Protocol 603 trial enrolment restarting following interim analysis demonstrating that main outcome (disease remission) was reaching statistical significance in ITT population and has reached statistical significant in PP population. Despite the initial concerns that the study design would make it difficult to detect a treatment effect, the effect size, or difference between the Prochymal and placebo response rates, of one dose arm of Prochymal is consistent with the original statistical assumptions of the protocol and is significantly outperforming placebo. (3)
    Mar 09 · The Prochymal Crohn´s PIII programme consists of two separate but related double blinded trials; the first (NCT00482092) to evaluate patients´ initial response to two dose levels of Prochymal (600 or 1200 million cells total over four infusions in two weeks) vs. placebo, and the second, an extension study (NCT00543374) enrolling subjects who successfully achieved clinical benefit (reduction in CDAI of at least 100 points) in the first study. The first trial was to enroll 270 subjects and the second, around 200. However enrollment was discontinued in March 2009 after 210 subjects had been enrolled because of a suspected design flaw resulting in significantly higher than expected placebo response rates; an interim showed that one of the two Prochymal dose arms had crossed a futility boundary. Because the current standard for determining response of Crohn´s patients to therapy is largely subjective, there may have been response bias to meet the eligibility requirements for continuation of therapy in the longer-term maintenance trial (1,2)




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