Thomas (our excellent moderator from yesterday) wheels up to introduce Alex Aimetti , who is the Sr Director of Medical Education and Scientific Support at InVivo Therapeutics. You should look this company up if you don’t know about it.
They’ve recently aligned and focused the company to only SCI. They have an acute program going; 1st person got a scaffold in 2014. And last December they started a new program aimed at chronics.
He’s addressing the acute/chronic issue … they’ve spent 3 yrs working on their acute scaffold project, but they know that the real goal is to get to chronics.
Ugh, series of colored sketches of a cross section of an injured cord after 2 hrs, after 1 day, and after 3 months. The latter is a big hole full of useless debris. So what’s the scaffold? It’s a bio-degradable substance that dissolves in a month or two, like one of those bandages they leave in you after surgery on purpose.
Okaaayyyyy. Video of surgery in progress. Shows them exposing the cavity, setting a little scale next to it, then (with tweezers) putting the scaffold right in there. What good does it do? It gives structural support to surrounding tissue to act like a bandage and preserve the integrity of what’s left after injury.
What happened when they put one of these into a rat acute injury? Lots of neuron sparing, much smaller cyst — and their slides show neuronal sprouting as well, along with Schwann cells.
What? Schwann cells live in the peripheral system, not in the central system … but they migrate.
So … their animal models worked well enough to get permission to work with people. It was designed as a 20-patient pivotal study with an endpoint of 25% improvement in ASIA impairment grade by 6 months post surgery. There are 23 clinical sites in the USA and Canada. They have 8 patients who have passed their 6 month window — and 5 of them have converted. One to ASIA C, 4 to ASIA B. All these people got implants within a day or less of their injuries. All of them were complete thoracic patients. Good news = zero adverse affects.
On to the chronic trials!
In the past, the method has been to drop a few million neural stem cells in a bolus injection right into the injury site. Their idea is to do that delivery differently, using a new injection device they’ve invented. Essentially this project is to create a new way to get the cells where they need to be and give them structure to stay there and do what they have to do — which is be a bridge between the working cells above the injury site and the working cells below it. They’re making a trail.
And that means building a machine that is an effective injection device, which they call a TrailMaker. They’ve tested it on uninjured pigs ….used their device to put human cells into pigs so they can be sure they have control over what the cells are doing & that their delivery thing is safe.
Like I said, have a look at their website.