Barman76, great question. My guess would be that yes, they would...

Barman76, great question. My guess would be that yes, they would be required to start at Phase 1. The FDA is extremely stringent in all of this.

Interestingly, the Ixmyelocel-T treatment for which Vericel got positive results uses a combination of Mesenchymal cells and Type 2 Macrophages.
The extraction method Vericel uses is obviously a curative process that is time consuming (I think its like 2 weeks from extraction to injection via catheter). But that is not really a constraint for them since the target population for Ischemic cardiomyopathy in the US is about 170,000 people, not a huge population compared to the CHF population Mesobalst is targeting.

Having said all that, I personally feel these various companies should pool together their resources to work on therapies (for the benefit of humankind) but I know that is not possible since each company wants to make it big on their own.