Great question. Look at the company Geron. They tried stem cells but ran out of $$$ NVIV is doing this in a step by step approach so they will have enough$$ In a perfect world Scaffold, Stem cell and Hydrogel would all work as a unit. But... the way NVIV will give them short term wins and lead to a major advancement in medical history. Just a little more time and this will all begin.
a1ag: Good response. I would add that the "step by step" approach includes "first things first approach". The primary player is the scaffold. As always with the FDA, the first step is to determine SAFETY (of scaffold) alone. The good part is, this is a medical device and if it proves to be safe, efficacy will also be apparent. Based upon the work done by GERN and CUR, safety of stem cells
in the spinal region is (IMO), a foregone conclusion. In short, if the FDA is satisfied with the scaffold outcome, we are over the hump. All the other stuff coming down the line will be potential iceing (sp) on the cake.
If you review the investor presentation on Nviv web site, you will see that experiments have been done using the scaffolding alone as well as with stem cells. The upcoming trial calls for using the scaffold only which seems to show effectiveness on its own. Scaffold+cells comes down the road much later. I believe trials associated with the hydrogels will come next.
Very interesting that the Miami Project is testing their Schwann cells right now. If they are shown to be safe and their efficacy is anything batter than placebo, the logical conclusion will be, "let's see if efficacy increases when synergistic with the InVivo scaffold. If this synergy is then observed, there will be stem cell companies lined up around the corner to work with InVivo Therapeutics on this medical intervention. Maybe even a strategic merger. Clearly NVIV will have the upper hand in having their IP protected biopolymer extracellular matrix.
Oh, by the way, InVivo Therapeutics has already an agreement in principle to work with Miami Project. Fortunately thanks to the regulatory delay for InVivo, the shortcomings of cells alone will be evident and highlight the need to adjoin these two approaches.
Actually, NVIV has already begun their research into chronic cure. Clearly science knows a cure will come from the synergy between cellular-tissue replacements and biopolymers together, along with the proper surgical procedure.