ChinaSCINet Update

[beuty]

I am sure that i saw in one of his post (I hope i am not wrong ,sorry it was a while ago and i could not find that post , if somebody can find that , please post it here again) , Dr. Silver was saying about the safety of CHAS' and he said " it is soooo safe" .My understanding is that Dr. silver has been working with CHAS' for a long time and he must have a good records and documenations about the saftey of CHAS' on animals in order to believe that CHAS' is safe .
Dr. silver would you please explain about the safety of CHAS' and please correct me if i am wrong that you believe that CHAS' is safe (sorry if i am wrong about your safety statment , it was a while ago that i read that ). thanks

every body finds his/her methode SAFE,
dr Silver finds chase safe, dr Davies decorin, dr vaquero mesenchymal cells, geeta schroff her own cells, and in China they have more than one thousand kind of SAFE cells,
the only one who is not safe, is the patient.

[GRAMMY]

Chondroitinase ABC (Generic SI-6603 Condoliase) is already in ongoing human clinical trials with a formulation adapted for clinical use. There is a clinical grade formulation being used in clinical trials and has been injected for human disc hernia. The clinical formulation of Condoliase has passed the safety phase for humans and has been licensed to be marketed by Kaken Pharmacuticals for disc hernia in Japan.
A Phase 2 has been requested to the FDA here in the US. All treatments need to undergo these kinds of human safety trials after the animal research has all been completed.

“SI-6603 will not affect the surrounding tissues or organs of the disc such as blood vessels and nerves. SI-6603 is expected to be a highly safe drug for patients with lumbar disc herniation. In October 2005, we completed construction of an investigational drug substance production facility, based on the latest GMP* standards. We are now involved in conducting Phase III trials in Japan.

GMP means Good Manufacturing Practice—a production management and quality control standard for pharmaceuticals and quasi-drugs.

Mine Higuchi
Senior Staff
Formulation Department

Central Research Laboratories
http://www.seikagaku.co.jp/ir/annual...df/ar06_07.pdf

[jsilver]

Thus far, over the past 2 decades and in all of the various animal studies ranging from rat to primate there has been no evidence reported of adverse effects from ch'ase injection into the normal or lesioned spinal cord. The half life of Chondroitinase in vivo is very short so it is gone in hours to days.

Chondroitinase ABC (Generic SI-6603 Condoliase) is already in ongoing human clinical trials with a formulation adapted for clinical use. There is a clinical grade formulation being used in clinical trials and has been injected for human disc hernia. The clinical formulation of Condoliase has passed the safety phase for humans and has been licensed to be marketed by Kaken Pharmacuticals for disc hernia in Japan.
A Phase 2 has been requested to the FDA here in the US. All treatments need to undergo these kinds of human safety trials after the animal research has all been completed.

“SI-6603 will not affect the surrounding tissues or organs of the disc such as blood vessels and nerves. SI-6603 is expected to be a highly safe drug for patients with lumbar disc herniation. In October 2005, we completed construction of an investigational drug substance production facility, based on the latest GMP* standards. We are now involved in conducting Phase III trials in Japan.

GMP means Good Manufacturing Practice—a production management and quality control standard for pharmaceuticals and quasi-drugs.

Mine Higuchi
Senior Staff
Formulation Department

Central Research Laboratories
http://www.seikagaku.co.jp/ir/annual...df/ar06_07.pdf

[Christopher Paddon]

Thus far, over the past 2 decades and in all of the various animal studies ranging from rat to primate there has been no evidence reported of adverse effects from ch'ase injection into the normal or lesioned spinal cord. The half life of Chondroitinase in vivo is very short so it is gone in hours to days.

2 decades? and still no clinical trials - thank you Acorda! But one has to ask why no clinical trials a long time ago?

Are all therapies going to take this long or is there a particular history to chase that has caused it to be held up so badly? Are there lessons to be learnt as to how to speed things up while maintaining the highest standards?

[KYLady]

Chondroitinase ABC (Generic SI-6603 Condoliase) is already in ongoing human clinical trials with a formulation adapted for clinical use. There is a clinical grade formulation being used in clinical trials and has been injected for human disc hernia. The clinical formulation of Condoliase has passed the safety phase for humans and has been licensed to be marketed by Kaken Pharmacuticals for disc hernia in Japan.
A Phase 2 has been requested to the FDA here in the US. All treatments need to undergo these kinds of human safety trials after the animal research has all been completed.

“SI-6603 will not affect the surrounding tissues or organs of the disc such as blood vessels and nerves. SI-6603 is expected to be a highly safe drug for patients with lumbar disc herniation. In October 2005, we completed construction of an investigational drug substance production facility, based on the latest GMP* standards. We are now involved in conducting Phase III trials in Japan.

GMP means Good Manufacturing Practice—a production management and quality control standard for pharmaceuticals and quasi-drugs.

Mine Higuchi
Senior Staff
Formulation Department

Central Research Laboratories
http://www.seikagaku.co.jp/ir/annual...df/ar06_07.pdf

Thank you, Grammy, for your informative and well-researched posts. When I see a post from you I always pay attention because I know I'll learn something!

[GRAMMY]

@KYLady, Thank you and I appreciate your kind words.

[debbie1341]

Thank you, Grammy, for your informative and well-researched posts. When I see a post from you I always pay attention because I know I'll learn something!

I was just thinking the same thing, thank you, Grammy!

[GRAMMY]

@debbie1341, Thank you also! I do hope that by sharing my information it helps the sci community.

[paolocipolla]

...

or
ask Paolo how to proceed

whatever is needed ... better than stall in this flight in this crucial moment,
just need a team to prepare

Comad,

I think your provocation in my regards it is good and usefull. We are in a war to get out of w/c here and kindnes & good manners don't fit well in this hell IMO.

How to proceed?
I wish I had a clear answer. I feel no researchers alone will get us a cure. Some researchers are actually taking advantage of our support, but don't have much to bring on the table when it comes to a cure for chronic SCI.
Some are doing their best, but their work is just a part of the solution.
Some have a mind set on stuff like E-Stim that at the end of the day will leave us paralized..
Some just don't give a damn about us, they just see us/our orgs as a souce of $.

As I said before, IMO a possible way out of this shit is to set up an SCI CURE X-Prize to get a good mix of competition & collaboration & set the mind of researchers toward the cure we really need.

I hope an X-Prize will be set up soon.

In any case we must keep a critical attitude to make sure we detect the BS that is being sold to us ASAP so we don't waste our money and energy in a wrong direction.

About clinical trial nets as I have said before I think they are not necessary at this stage to test terapies for chronic SCI. People with chronic SCI can easily travel, so one well equipped clinical trial center is all we need to test a therapy without wasting time & money to get to a consensum clinicians... big expencive meetings etc..

So far Wise has failed to convince me about the need of a clinical trial net, I think he is just still in love with the old NASCIS (being provocative here ) and the facts so far seem to say I am right here.

Paolo

[moneymaker]

..............

[muskie]

whoa! really, listen you don't have to agree with paolo but I think you have crossed a line

[Jim]

I dont know what was said but was told it wasn't pleasant. Please do not attack other members. We are all on the same team here.

[t8burst]

About clinical trial nets as I have said before I think they are not necessary at this stage to test terapies for chronic SCI. People with chronic SCI can easily travel, so one well equipped clinical trial center is all we need to test a therapy without wasting time & money to get to a consensum clinicians... big expencive meetings etc..

Paolo

Can you explain your logic behind this? I am not being argumentative, quite the opposite I travel quite a bit (Delta Diamond) and because of that pretty much figure I would not be able to participate in any clinical trial. Wouldn't the surgery to implant the stem cells require at least a month of hospital/recovery? Isn't there are pretty rigorous physical therapy regime following the implantation as well?

Thanks,
Tom

[comad]

Lets play the game....let's dream
X prize would be 1 Billion dollars.
If 1% of the richest people bounded to wheelchair due to chronic SCI know they would be healed if they pay $ 50,000 there will be 20,000 people able to collect 50 K's. In 3 months. And that's a Billion.
Price will drop for others with more people saying "I will invest in my healing"
(something like www.kickstart.com)
With only 10% of that X prize we would be able to build fantastic facility lets say on Cuba where is available huge network of very inexpensive medical personals (excellent doctors and physio therapists).
All major players (doctors) in the SCI healing game would be welcomed to work together and share researches with less restrictions with a ultimate prize in sight.
Red Bull can put their Logo on my forehead if they inject initial capital.
(actually, let's make auction for sponsorship calling Red Bull, Nike, Adidas, Google, Apple )
So, money exist, promising therapies exist, wounded people with their families exist ... Honest doctor's who want to dedicate their research to human healing exists...One just need to facilitate and connect right threads.

wAke up and fill your numb body...

Reality will be probably very close to Dr.Wise plan except there
is moment of good surprise that will by the end of 2013 put much stronger spotlight on people in America walking again and much more people talking and screaming here asking to get into cure boat.

Crossing my fingers and pray for Dr. Wise and his therapy from the bottom of my heart.

Comad,

I think your provocation in my regards it is good and usefull. We are in a war to get out of w/c here and kindnes & good manners don't fit well in this hell IMO.

How to proceed?
I wish I had a clear answer. I feel no researchers alone will get us a cure. Some researchers are actually taking advantage of our support, but don't have much to bring on the table when it comes to a cure for chronic SCI.
Some are doing their best, but their work is just a part of the solution.
Some have a mind set on stuff like E-Stim that at the end of the day will leave us paralized..
Some just don't give a damn about us, they just see us/our orgs as a souce of $.

As I said before, IMO a possible way out of this shit is to set up an SCI CURE X-Prize to get a good mix of competition & collaboration & set the mind of researchers toward the cure we really need.

I hope an X-Prize will be set up soon.

In any case we must keep a critical attitude to make sure we detect the BS that is being sold to us ASAP so we don't waste our money and energy in a wrong direction.

About clinical trial nets as I have said before I think they are not necessary at this stage to test terapies for chronic SCI. People with chronic SCI can easily travel, so one well equipped clinical trial center is all we need to test a therapy without wasting time & money to get to a consensum clinicians... big expencive meetings etc..

So far Wise has failed to convince me about the need of a clinical trial net, I think he is just still in love with the old NASCIS (being provocative here ) and the facts so far seem to say I am right here.

Paolo

[t8burst]

There is a saying "you can't make a baby in a month by getting nine girls pregnant". No matter how much money you throw at the problem it will take time to solve. Could more money make it faster? Sure. No matter how much money you throw at it, it will still be years.

Lets play the game....let's dream
X prize would be 1 Billion dollars.
If 1% of the richest people bounded to wheelchair due to chronic SCI know they would be healed if they pay $ 50,000 there will be 20,000 people able to collect 50 K's. In 3 months. And that's a Billion.
Price will drop for others with more people saying "I will invest in my healing"
(something like www.kickstart.com)
With only 10% of that X prize we would be able to build fantastic facility lets say on Cuba where is available huge network of very inexpensive medical personals (excellent doctors and physio therapists).
All major players (doctors) in the SCI healing game would be welcomed to work together and share researches with less restrictions with a ultimate prize in sight.
Red Bull can put their Logo on my forehead if they inject initial capital.
(actually, let's make auction for sponsorship calling Red Bull, Nike, Adidas, Google, Apple )
So, money exist, promising therapies exist, wounded people with their families exist ... Honest doctor's who want to dedicate their research to human healing exists...One just need to facilitate and connect right threads.

wAke up and fill your numb body...

Reality will be probably very close to Dr.Wise plan except there
is moment of good surprise that will by the end of 2013 put much stronger spotlight on people in America walking again and much more people talking and screaming here asking to get into cure boat.

Crossing my fingers and pray for Dr. Wise and his therapy from the bottom of my heart.