Allogeneic stem cells look promising for perianal fistulas in Crohn's disease patients

TiGenix NV (Belgium) have announced results from their Phase III ADMIRE-CD trial of allogeneic expanded adipose-derived stem cells for Crohn's disease.

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Mar 17, 2016
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TiGenix NV (Belgium) has announced results from week 52 of its Phase III ADMIRE-CD trial investigating allogeneic stem cells, stating that they look promising for the treatment of perianal fistulas in Crohn's disease patients. The data suggest that a single injection of Cx601, a suspension of allogeneic expanded adipose-derived stem cells, was statistically superior in achieving combined remission than placebo among trial participants.

ADMIRE-CD is a randomized, double-blind trial of 212 patients in seven European countries plus Israel. The trial recruited Crohn’s disease patients with complex perianal fistulas with inadequate response to previous therapies, including anti-TNFs. While the primary endpoint of the study was combined remission at 24 weeks, it was analyzed again at 52 weeks as a secondary variable.

Marie Paule Richard (TiGenix) commented on the results: "We are delighted with the remarkable consistency of these results with respect to those reported at 24 weeks. In particular, the 75% persistence in the combined remission from week 24 to week 52 confirms Cx601 as a promising therapeutic solution for a hard to treat population that is refractory to existing treatments including anti-TNFs. The improvement brought by Cx601 compared to the best standard of care available could make a real difference to the life of patients suffering from this chronic disease".

Alongside statistical superiority of combined remission compared to placebo, the efficacy of Cx601 was robust and consistent across statistical analyses. In addition, serious and non-serious adverse events were comparable between Cx601 and control groups.

"The one year results of this large robust controlled study open up a new paradigm for the treatment of perianal fistulising Crohn's disease, one of the most severe manifestations of this process. With a single injection of Cx601 more than 50% of patients are in remission at one year with a favorable safety profile. Remarkably, most patients that were already in remission at six months continue to benefit from the treatment six months later, a major breakthrough in this field", added Julián Panés (Hospital Clínic of Barcelona, Spain).

– Written by Daphne Boulicault

Source: TiGenix press release: https://globenewswire.com/news-release/2016/03/07/817563/10160751/en/TiGenix-announces-positive-52-week-Phase-III-results-of-Cx601-in-complex-perianal-fistulas-in-Crohn-s-disease-patients.html?elqTrackId=c45efaa153cf4078992d2fa74e44b308&elq=952f28f8a15243a

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Go to the profile of James L. Sherley, M.D., Ph.D.

A very exciting report from what seems to be an ideally designed clinical trial. More like this one are needed! Looking forward to more details of the study when published. For example, what was the allocation of the allogeneic transplantation cells and what was the immunosuppression regimen employed? Because of the matching required in the setting of allogeneic transplantation, it seems likely that patients received individualized transplant preparations. Of course, Asymmetrex would suggest that counting the number of stem cells in transplantation samples might further informed the findings. Similarly, future studies comparing other sources of tissue stem cells (e.g., CD34-selected bone marrow cells) non-stem cell containing fractions as comparison controls might better inform as well regarding the stem cell-specificity of the patient outcomes.

As the organizer for the February 2017 Zing Conference on "Challenges, Solutions and Progress in Stem Cell Medicine" (http://www.zingconferences.com/conferences/challenges-solutions-and-progress-in-stem-cell-medicine/), I hope the study authors will consider presenting their exciting results in more detail, and any updates, at this conference.

James Sherley
Asymmetrex, LLC
jsherley@asymmetrex.com
jsherley.zingconference@gmail.com for Zing Conference correspondence