Implant for spinal cord (Karolinska institute, Sweden)

[pmh]

This technology sounds very promising. Apologies if already posted.

Original article in swedish published on April 26 2012 on Ny Teknik (New Technology)

Translation by Google:

A centimeter wide implant offer hope for spinal cord injured. In just 14 days, new nerve fibers grow back. The implant then disappears without a trace. Clinical trials with 24 spinal cord injured patients is now planned at the Karolinska Hospital.

Just over a year ago, Ny Teknik described a new type of implant that was developed in collaboration between the Karolinska Hospital and Stockholm company BioArctic Neuroscience. The implant, which is filled with a drug, should fix torn nerves. The results of animal studies have been successful.

Now planned is an initial study of 24 patients who are paralyzed by a total break in the spinal canal.

- It's the first time in the world that this is done, says Pär Gellerfors, CEO of BioArctic Neuroscience.

The implant, manufactured by the Swedish company Elos Medtech, is made in 60 different sizes.

- It is only when the spinal cord is exposed that you can see what the radius and length of the implant should have, says Pär Gellerfors.

At the surgery the damaged portion of the spinal cord is removed and replaced by the implant.

In just 14 days, new nerve fibers grows through the twelve channels running through the implant. This restore nerve function. The implant is then broken down by the body - leaving only the new nerve fibers.

BioArctic Neuroscience has now received the implant protected as an orphan drug in both Europe and the USA. This means that companies who produce a treatment for patients with rare diseases, including the right to seven to ten years exclusivity in the market.

- We expect to submit an application for clinical trial by the MPA at the end of the year, says Pär Gellerfors.

[StemCells&AtomBombs]

It says that, "the implant is filled with a drug."

Does anyone know what drug that would be?

Does anyone know when the trial is set for?

I guess I'm asking if anyone has had any contact with this group in Sweden?

[topperf]

Found this, an ran it through google translate.

The development of a centimeter large implants can provide patients with a fractured spinal canal after traffic accidents, falls and diving in shallow water, a better life.

The implant is made in 60 different sizes. For the exact radius and length of the implant should have, you know first when opened to the patient's spinal cord.

On the other hand by the developers of the implant, it may be damaged nerve fibers to grow beyond 14 days.

Nerve filaments grow through the 12 channels that pierces the implant. When it has completed its task, the implant is broken down by the body. What remains is just the nerve fibers.

The Karolinska Hospital, which together with its Stockholm Business Bioarctic Neuroscience has developed the implant, and Elos Medtech, which received the Engineer Product Award last year, which manufactures it.

Research from the 1990s
In Bioarctic Neuroscience says CEO Pär Gellerfors:

"It is research that began in the early 90s at the Karolinska Institutet, where they tried to create a treatment for spinal cord injuries. The challenge was to know that the nerves and neural pathways in the brain do not grow out. The peripheral nerves are not the problem they actually regenerate. "

It would benefit from:

"So they created a method so to speak, transplanted nerves into the spinal cord in rats with spinal cord injuries. The hypothesis was that it would redirect signals. It was the great innovation, "says Pär Gellerfors.

The results were already published in Science in 1996. Since people have tried to translate the research into a product.

"It has taken its years. What others have created is an implant that Elos Medtech manufactures, and which can make surgery very accurate and robust. Formerly operated man 'in the free hand'. But it is not clinically. Required an implant, "says Pär Gellerfors.

What kind of material he has no desire to say more than that it is' a biodegradable substance. " It has been degraded three or four weeks after it has been transplanted, in which the nerve fibers are re-established.

"At that time, the rats had their movement in the legs and restored the ability to control urine and feces," says Pär Gellerfors.

Studies in patients
Experiments with rats have been successful, so now is the first clinical study of 24 paralyzed patients scheduled.

"This is the first time in the world that it happens," says Pär Gellerfors who plan to submit an application for clinical trials for the Swedish Medical Products Agency at the end of the year.

Does the clinical trials, as they should, the treatment can be ready in four to five years, the Pär Gellerfors.

The longer the intention is to develop treatment for patients with older rygmarvsbrud.

Bioarctic Neuroscience has been protected as an implant specialist agent in both Europe and America. It gives the company seven to ten years of market exclusivity.

In the U.S. biotech company Geron to start clinical trials of stem cell repair of spinal cord injuries.

[topperf]

Looks like its for acutes.. dammit.

[Leif]

From the companyes home page

http://www.bioarctic.se/news/bioarct...t-from-vinnova

[Dmitriy]

Here is more info on this:
http://www.bioarctic.se/traumatic-sp...1device-sc0806

[BSgimp]

Looks like its for acutes.. dammit.

You think it will not translate into chronic. It says they remove the damaged tissue anyway so might as well remove the scar and put this thing in. I think they will do everything to market it for chronics too. Capitalism and human nature is on our side.

[paolocipolla]

From the companyes home page

http://www.bioarctic.se/news/bioarct...t-from-vinnova

Leif!
Nice to see you are still around!

Is Norway SCInet going to be involved in this clinical trial?

Paolo

[Jawaid]

Nice if works and we can hear soon

[StemCells&AtomBombs]

Sounds interesting, but I also wonder if it can be applied to chronics.

Capitalism and human nature is on our side.

Really? Capitalism hasn't been very helpful with the Acorda situation and Ch'ase. The whole idea that you can own something that can have a profound impact on society and decide that you don't want to use it yet, is exact example of why there isn't yet a cure.

[StemCells&AtomBombs]

Looks like its for acutes.. dammit.

"The longer the intention is to develop treatment for patients with older rygmarvsbrud."

I guess this is the line about the future development for chronics.
Why didn't I study Swedish?

[topperf]

That sentence exactly, led me to my initial conclusion.

[Fly_Pelican_Fly]

I immediately become cynical when there is talk of 'removing damaged tissue'. This sets off all sorts of alarm bells for me. What is this damaged tissue? How do we know there are'nt any healthy axons in there? And how will this be done without more gliosis and fibrosis entering the lesion area?

Invivo talks of this. Lima talks about removing tissue. Help me out here please?

[Jawaid]

Any one did contact these peoples whether this implant will be effective in chronic injuries or only for acutes? Any one here from Sweden who can update?

[GRAMMY]

Any one did contact these peoples whether this implant will be effective in chronic injuries or only for acutes? Any one here from Sweden who can update?

For now this is being designed for acute injuries. It will be many years before it reaches the chronic phase of development and testing.

BioArctic Receives Grant from VINNOVA
2012-04-03
Today, VINNOVA announced that BioArctic Neuroscience AB was granted 3.5 million SEK for the clinical development of its proprietary
product with the indication Treatment of Traumatic Spinal Cord Injury.
VINNOVA is The Swedish Governmental Agency for Innovation Systems that supports research and development work of the highest quality.
BioArctic is developing a new treatment for traumatic Spinal Cord Injury together with The Department of Clinical Neuroscience and
Neurosurgery, Karolinska Institutet and Karolinska University Hospital.
The product under development is a biodegradable device with a growth factor, which will promote and guide nerve growth in the spinal cord and restore function. During a neurosurgical procedure the injured spinal cord will be replaced by the product.
Currently, there are 2.5 million victims suffering from Spinal Cord Injury, which is a devastating condition with loss of motor function and sensibility below the injured segment.

There are no effective treatments for complete traumatic spinal cord injury, which is a chronic, devastating condition leading to markedly impaired life quality and very high economical costs to the society, says Dr. Pär Gellerfors, CEO of BioArctic Neuroscience.

The company intends to develop the current product for "complete" acute spinal cord injury into the segment of "incomplete" spinal cord injuries and then eventually as a treatment for older injuries which is a 2.5 million patient market.