Cell Therapy News/Articles, page-14360

We may well find that the original Crohn's trial worked, but required such a high dose of cells that the pharmacoeconomics didn't make sense compared to highly profitable treatments like back pain. Dr Lightner's new trial uses a much lower number of cells delivered directly to the site rather than an IV infusion where the cells go through the lungs first, then through the rest of the body before reaching fistulae. The amount that can be charged for this disease is limited by a number of factors - but you wouldn't be able to charge anywhere near the dollar value of aGvHD which uses a similar number of cells in kids (ballpark figure). It would be silly to produce the high numbers of cells required for the original trial of Crohn's when there is an urgent demand in dying kids with aGvHD and where the cost of treatment can be justified at much higher dollar values.

The original trial for Crohn's Protocol 603 trial involved injections of PROCHYMAL delivered through a vein in the arm four times over two weeks. The low dose was a total dose of Prochymal® 600m cells, IV infusion, on four days, once daily and the high dose was a total dose of Prochymal® 1,200m cells, IV infusion, on four days, once daily.

That's higher doses than kids' aGvHD which uses 2m cells * 25kg to 30kg * 4 weeks * 2 doses per week = 400m to 480m cells - but there's no way you'd get remimbursement of over $300k per patient in Crohn's as appears possible in aGvHD. So, I suspect there's no work being done on the original Crohn's trial analysis as MSB waits for data on Dr Lightner's latest trial which has had spectacular success in the results presented so far and which only uses 2*150m or 2*300m cells as the dose (ie 300m or 600m in total) - which is half the dosage of the original trial (probably with much better results).