If the human tissue is more than minimally manipulated, a premarket approval is required. Biological drugs (biologics) need approval as in Myocell via the BLA approval process.
I read the celltex issue. Celltex was claiming that the cells were "minimally manipulated" which fall under a less strict regulation with the FDA which is stated in the email I posted. The FDA said otherwise.
Myocell is considered more than minimally manipulated in a lab where it would require pre market approval with results from a phase 3 trial under the BLA process. It's all in the body of the email I posted.
I said autologous stem cells being a potentially smaller biologic trial not all biologic trials are smaller
Mesoblast is an allogeneic stem cell direct competitor of bioheart. They have a 1700 patient trial.
Cardio3 is an autologous competitor with a smaller trial more on par with Bioheart's trial size.
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