It is a start for Acutes and gives the Chronics hope for the future. I spoke to their clinical department and Chronic testing and implantation of the scaffold is there next step in clinical work. It gives me a positive future outlook. Best to All and have a great weekend!
InVivo Therapeutics Reports Significant Improvement of First Patient Implanted with Neuro-Spinal Scaffold™
CAMBRIDGE, Mass. (Oct 23, 2015) – InVivo Therapeutics Holdings Corp. (NVIV) today announced a 12-month post-implant update for the first study patient in the company’s ongoing pilot trial of its investigational Neuro-Spinal Scaffold™ in patients with complete acute spinal cord injury.
In the time between the 6-month and 12-month post-injury assessments, the patient continued to demonstrate improvement in the American Spinal Injury Association (ASIA) lower extremity motor score with an additional 8 points gained on this 50 point score. The patient demonstrated additional bilateral improvements in the motor function of hip flexors and knee extensors and for the first time bilateral contractions of the ankle dorsiflexors and ankle plantar flexors.
A large natural history database shows that patients with similar level injuries (T10-T12) have an average increase of lower extremity motor scores between 6 and 12 months of fewer than 2 points.
“I am delighted that our first patient continued to experience significant motor improvement after the 6-month visit. It is particularly exciting that the patient is regaining motor function in the ankle region as this indicates recovery is occurring not only in muscles that demonstrated some early recovery, but also in new muscles further down the legs. We are all hoping for continued improvement for the patient in the future. It was a brave decision to volunteer to be the first person ever to receive our investigational product, and it has been rewarding to observe the patient’s steady improvement over the last year,” said Mark Perrin, InVivo’s CEO and Chairman.
This surgical device implant from InVivo Therapeutics and coincidentally named the INSPIRE trial, is looking very promising indeed. Once there are 20 enrolled patients, they monitor medical recovery and safety for another 6 months and then it can be submitted to FDA for approval and commercial availability. This trial had a slow uptake rate but it is finally close to completion. There are a number of patients who have not reached the 6 month interval, but this has been running approximately 50% showing AIS conversions, improved bladder & bowel. This will surely become the new interventional standard of care for acute SCI. Safety has been excellent, so who wouldn't want this done if you sustain an injury. The 6 month eval is for practical purposes; they expect improvements can continue more long term. WHat is especially nice is that instead of scar tissue being formed at the lesion, there is remodeled neuro-permissive tissue and spared white matter. Once this is available, there will be collaborations to add things like Schwann cells and biological factors to this scaffold to make it even better. It's great that the FDA is becoming more progressive.
I remember watching the founders presentation on this some years back. Funny thing is he's not with the company anymore lol. At least last I checked. I'm still hopeful though for any and all breakthroughs
Don't want to burst the bubble but i think its that guy Frank Reynold ex owner of the company who claims to have been SCI and invented a cure for himself. I'read his profile on line and do not have a good opinion especially when he calls other people assholes. (locker room talk mentality) He now claims to have been booted out of his own company.
One conclusion i have is he's fame and money mad and very full of himself.
PS: While i to pray for a cure must keep feet on the ground, any real proven break through will be a nobel prize and verified by independent and well established authorities of good reputation. God knows how many stories i have read on line about cures and treatment clinics but what are they stories and money traps. Same goes to that doctor who once claimed to have ASIA A patients walking somewhere in China. God knows how we pestered him for info. 3 to 4 years on and nothing. Very strange how not one of his ex patients has ever posted about the treatment.
Delboy is 100% right about Frank Reynold. Complete moron and dangerous particularly for recent injured patients to read his bulls*it story.
I remember watching his TED talk back in 2010 and couldn't believe that they had allowed him on stage! I believe nowadays they are more diligent about the type of people they invite. Unfortunately because he has a TED talk to his name and provides him an element of unwarranted legitimacy.
If you watch just the first 5 minutes of his TED talk with regards to his own injury he says that he was completely paralysed and spent 5 years in bed "researching" spinal cord injury and then says "long story short-I cured myself." And offers no explanation at all about how he magically cured himself after being bedbound for 5 years which would cause massive atrophy and degeneration meaning the body would most likely be beyond walking. All reputable scientists involved in spinal cord regeneration identify keeping the body in the best possible shape by physio et cetera is likely to be critical in the success of any cure.
As we all know-many spinal-cord injury patients end up being incomplete injuries where they regain/retain the capability of walking after the initial spinal shock/stabilisation has occurred.
That is even if he had an accident in the first place-I wouldn't believe a word they came out of his mouth.
Also that "long story" would be gladly listened to by hundreds of thousands of patients around the world and if it were true it would be worth millions if not billions of dollars-surely that would be worth writing down! Obviously it's complete rubbish.
I don't know any one at invivo but Frank on his website makes all sorts of bizarre claims about why they sacked him. It boiled down apparently to weekend expense claims of tens of thousands of dollars which he claimed were for conferences but the company claimed he used for a family party. I would be inclined to believe the latter.
It's great that he has nothing to do with invivo now but I would still be dubious about anything this dangerous individual has had any involvement with. He's effectively being convicted of fraud which begs the question-what other things might he been fraudulent about?
Third paragraph from 2015 (he lied about cause of SCI then made up a story- very trustworthy)-
Reynolds, who was chairman, CFO & CEO, left InVivo suddenly in August 2013, citing a "medical condition." Back in 2009 and 2010, Reynolds told MassDevice.com and Inc. magazine that he’d suffered spinal cord injury of his own in a 1992 car accident that left him partially paralyzed. The executive later retracted the story, saying instead that he injured his back loading a truck and suffered spinal problems after a 1992 surgery to treat the injury.