So how long does it take for a great idea to make it to the marketplace? Well, if it’s a medical innovation, it can be a decade or two.
Take the ideas of Bob Langer (here’s one of the previous times I’ve mentioned him on my blog). A Chem E professor at MIT, this brilliant guy has been involved in the development of myriads of devices- and a fair share of corporate entities.
Way back in 2002, Drs. Y.D. Teng, X Qu, K.I. Park, J. Ourednik, E.Y. Snuder (Harvard Medical) D. Zurakowshi (Children’s Hospital, Boston), E.B. Lavik (then an MIT PhD candidate, now Case Western) and Robert Langer (MIT) published their research findings regarding spinal cord recovery. Their article in the Proceedings of the National Academy of Sciences (Functional recovery following traumatic spinal cord injury mediated by a unique polymer scaffold seeded with neural stem cells) described the ability to restore functionality to rats that had significant spinal cord injury.
This sort of injury is a real problem. Some 8000 to 10000 patients a year succumb to paralysis as a result of spinal cord injury. And, the typical therapy has been to repair the broken spinal column with rods and screws. Which really isn’t a therapy, since this does not restore the spinal cord’s ability to transmit electrical impulses from the brain to the rest of the body.
So, the firm started by Bob Langer, In Vivo Therapeutics (Cambridge, MA) is pursuing the process first explained in the paper mentioned above. The experimental regimen cuts into the patient’s spinal column, into which a neuro-spinal scaffold (while the initial studies on rats and monkeys included stems cells, they have not been used in humans- because of the US policies against such stem cell use) is inserted. The bio-degradable scaffold serves as a trellis, promoting neural growth into the break, which restores spinal cord integrity. And, over several weeks, the inserted scaffolding degrades and disappears.
To date, some three folks have been subjected to this new therapy. (The FDA has approved trials for up to five folks, as of now.) The first patient (who was paralyzed from the waist down) recovered some motor function; the second recovered sensations- but no motor function. The third patient has recovered sensation in his abdomen and legs, along with some bladder functionality. So, that makes two of three patients who recovered some motor function.
Of course, one would expect much better results – like full motor functionality- if stem cells were employed in the therapy. (Growth factors that could afford nerve regrowth may also be useful, but they have not yet been included in the protocol.) But, that is not in the cards- yet (because of the stem cell ban in the US). And, the FDA has provided In Vivo “humanitarian use device” designation- that means only “probable benefit” must be afforded to obtain permission for wider use. But, this still remains a pilot study, using the FDA’s IDE (investigational device exemption) protocol. (This – then nascent- protocol was how we developed and tested our bicarbonate dialysate 35 years ago.)
Now, if Bob’s group could only use stem cells…
