Let’s not get excited about stem cells and GI bleeding

I’m as disappointed as everyone else here about today’s results both because the study failed to satisfy the primary outcome and because it was handled so poorly.

The announcement from MSB today hints that the FDA might fast track a product for GI bleeding but I have a few points that I think need to be addressed.
- the trial assessed intramyocardial injection of cells (as in directly into the heart). Surely this isn’t the optimal route of delivery for reducing GI effects. If the reduction in bleeding is due to an antiinflammatory effect should be seen with intravenous or even subcutaneous injection.
- the doses decided in the earlier trials weren’t for GI bleeding.

together this means more trials - so more time and money.

I think it’s worth noting that these results are from an independent trial which makes it even more difficult to digest - good results would have given more credibility to other trials.

And where do these results leave us with the heart failure trial? And others?

i think the results for ESHF will be along the same lines and won’t be what we are hoping for (although I hope I’m wrong). If results are less than stellar we need to move away from CVS indications all together. It’s no good flogging a dead horse.

Priority number 1 is FDA approval for GHVD. That’s a proven therapy. Keep in mind that today’s lack of improvement is also a lack of harm - more safety data for MPCs! and the board seriously needs to consider how that money should be spent. I don’t want them to go alone after the shambles today, we need a partner to take the product to market.

I’m still very optimistic about MPCs for chronic back pain, it makes sense that the antiinflammatory and cellular nature of MPCs will reduce pain. That’s a huge market and should be heavlily invested in.

In the mean time no more trials please!