ChinaSCINET, On Schedule?

[Schmeky]

Dr. Young,

Just wondering if the combination trials (lithium and HLA matched Umbilical Cord Blood Stem Cells) are still scheduled to begin in June of 2007 (only 5 months away)?

Also, you previously indicated there are 20 participating SCINET centers. Do you have any idea how many different treatments will begin testing this year?

Thanx

[Wise Young]

We are still working out the regulatory, cell sourcing, and funding issues. At the present, I do not anticipate that we will be able to reach our goal of starting the combination cell transplant and lithium trial by June 2007. The combination trial is more likely to start in early 2008.

Wise.

[KIM]

"I know Dr. Young would not agree, but getting something effective and beneficial to humans as quickly as possible should be the ultimate goal. The delay of even a single day of therapies to humans is unacceptable."

Schmecky

[Schmeky]

Thanx for the update Dr. Young. I know you're doing everything that can be done. This is an enourmous undertaking.

[Rollin Rick]

I know this is an enormous task, but that really hurt. I'm sure most of us had our heart set on June, but I guess it's just like anything else, it always gets pushed forward. Another whole long year before anything gets started. This has just become a sad day.

I know Dr. Young is doing everything he can for us, but I just cannot help to feel that a big brick has fallen. Sorry for rambling on, I'll feel better tomorrow. Hopefully the wiggling of toes will be in 2008.

[litespeed4]

Dr. Young, thanks for the update. It's much better to be realistic and tell us what the status is now rather than wait until June.

Can you give give us an update on the funding situation? While there is not much we can do for the most part this is an area where we actually could help.

[Faye]

"I know Dr. Young would not agree, but getting something effective and beneficial to humans as quickly as possible should be the ultimate goal. The delay of even a single day of therapies to humans is unacceptable."

Schmecky

Yeah, I remember the initial China SCInet called for the enrollment of 600 people in 2006.

I guess that makes it a 2 year delay now.

Maybe smaller is better after all.

[Chaz19]

wise -- those are tough words to breathe in as im sure they were for you to write. is it possible that you will know the results from the single lithium trial this year?are there any small satellite combination therapies going on in conjunction with ChinaSCI or similar infrastructure being created in United States without CRPA? thank you again for your ongoing hard work and be well!

Faye, do you have any evidence of small trials that have shown successful restorative therapies? it is completely out of my area of expertise to know why a small study would be better than a large study -- or vice versa --I can only make guesses. but regardless, I'd be satisfied to see any sort of progress, whether it's minute or gargantuan as long as it is valid n peer-reviewed.

[Wise Young]

Dr. Young, thanks for the update. It's much better to be realistic and tell us what the status is now rather than wait until June.

Can you give give us an update on the funding situation? While there is not much we can do for the most part this is an area where we actually could help.

litespeed, thanks for the offer.

Let me first comment on the setting of goals. I believe that one should adopt ambitious goals. The alternative is to set up conservative goals and people don't work as hard to achieve them. I know that it is disappointing to people when we do not achieve all of our original goals (as it is very disappointing to me as well) but it makes us work harder. By the way, we have achieved many of our original goals. All the centers are now using a single neurological standard and dataset for evaluating the therapies that they are testing (many are testing experimental therapies, as you know). Over half of the centers are now GCP qualified and we anticipate that the remainder will be qualified by the end of the year. The phase 1 lithium trial has started at Hong Kong University. We were recently told that the phase 2 lithium trial can be started in China within 2007. We are bringing 60 of the top Chinese spinal surgeons to Kunming next month to reach a consensus concerning the best way to transplant cells into human spinal cord.

There are three major obstacles to getting the combination trial (CN103) going.

The first is funding. I estimate that the combination trial will cost US$12 million (for clinical trial costs alone) and an additional US$12 million for estabishing GMP (Good Manufacturing Practice) cell processing faciities Over half of my time is dedicated to raising this money. To facilitate this effort, we have now created two non-profit companies. One is called China Spinal Cord Injury Network Inc. and the other is the charitable fundraising arm China Spinal Cord Injury Fund. We are working very hard to raise these funds.

The second is the new clinical trial regulations in China. About two years ago, the sFDA (the Chinese equivalent of the US FDA) and the Ministry of Health (MoH) passed onerous new regulations that imposed very high standards on all clinical trials, higher than in the United States, for example. The requirements include getting GCP (Good Clinical Practice) certification not only of the hospital but of the department carrying out the clinical trial. Approval of clinical trials take a minimum of 9 months and often years, especially when there are no precedents for decisions. Our trial will be the first combination cell transplant and drug trial for spinal cord injury. We have been working closely with the leadership of both the MoH and sFDA for the past two years to achieve rapid approval. In fact, we just had very productive meetings with both agencies in Beijing.

The third is turmoil in Chinese regulatory agencies. In 2004, the sFDA received over 10,000 new drug and product applications, and approved many of them. There have been charges of corruption and low standards. The former head of the sFDA and several of his colleagues, and his son, were fired and jailed recently. The leadership of the sFDA was changed recently. The premier of China called for a complete investigation and even re-evaluation of many of the drugs and clinical trials that have been approved. The current sFDA is embattled http://www.scidev.net/content/news/e...vestigation.cf but we were very surprised in a visit to them last week that they really want to help us.

Wise.

[adi chicago]

to rebuild a smashed strawberry is very hard.i hope that one day ...not me but others sci will walk and have a normal life again .me too ...why not?

[spidergirl]

This is very sad.

I think a majority of the people on this forum believe that you are going to come up with a cure Dr. Young. You give us all hope and reasons to believe even mentioning that "cures will arrive sooner than later" knowing that your trials have been set back. Are you saying that we should have "hope" because of other therapies other than your own?

24 million needs to be raised for a lithium trial? umm I'm thinking is there substantial enough evidence that Lithium is gonna help? Because if there is I don't see a problem with you being able to get that money. I don't know how many times I have mentioned Proof to people and noone seems to get this. There are lots of wealthy people willing to spend money on proof. Nobody want's to spend momey on testing safety. Forget it! Efficacy needs to go hand in hand.

In addition to this,

Is there any reason why anyone of us on carecure should actually believe we are going to be helped at all with this hellish condition? I am not here rambling on there are some things I am working on and there no joke, but I just think I come to carecure to read up about the progress of the cure around the world/planet not to discuss who I am having sex with, in what position, how often I should empty my bladder etc..that is what doctors are for.........

If there is NO HOPE in the near future for a cure why are we all here? This is so confusing Dr. Young, truly. I think you do realize the sense of urgency and I am not saying anything is your fault, I know your doing your thing, but this is truly unacceptable in every which way and meaning of the word. It is NOT FUNNY to not walk.

[adi chicago]

This is very sad.

I think a majority of the people on this forum believe that you are going to come up with a cure Dr. Young. You give us all hope and reasons to believe even mentioning that "cures will arrive sooner than later" knowing that your trials have been set back. Are you saying that we should have "hope" because of other therapies other than your own?

24 million needs to be raised for a lithium trial? umm I'm thinking is there substantial enough evidence that Lithium is gonna help? Because if there is I don't see a problem with you being able to get that money.

In addition to this,

Is there any reason why anyone of us on carecure should actually believe we are going to be helped at all with this hellish condition? I am not here rambling on there are some things I am working on and there no joke, but I am just think I come to carecure to read up about the progress of the cure around the world not to discuss who I am having sex with, in what position, how often I should empty my bladder..that is what doctors are for.........

If there is NO HOPE in the near future for a cure why are we all here? This is so confusing Dr. Young, truly. I think you do realize the sense of urgency and I am not saying anything is your fault, I know your doing your thing, but this is truly unacceptable in every which way and meaning of the word.

spidegirl ...is not easy to treat [cure] sci.the neuro pain uti s spasms are my most killers .i hope and i will fight until the end .i don`t agree with false hope .i had the oeg procedure done .we have to understand only one thing...the science will solve our problem one day ...sooner or later.i will die happy tomorrow if i will hear...the cure for sci exists.is hard and the damn goverment is not help us.

[spidergirl]

the science will solve our problem one day ...sooner or later.i will die happy tomorrow if i will hear...the cure for sci exists.is hard and the damn goverment is not help us.

NO ADI-

the science may NOT solve our problem one day. More people are interested in investing in technology. Technology is moving forward at the pace of a skyrocket. Science makes track marks like a snail on the sidewalk.

( very cute avatar BTW )

[Wise Young]

Cheryl,

I am sorry that you think that it is very sad. Let me, however, correct several misperceptions.
• $24 million is not needed for a lithium trial. $12 million is required for the combination cell transplant and lithium treatment trial. Another $12 million is required for establishing GMP cell processing facilities unless we form a partnership with an existing facility. We have been exploring all these options.
• I have only said what gives me hope. You can decide whether what I say gives you hope. if you read my posts, you will find that I spend most of my time talking about reasons for hope based on many people's work, not just my own. We want to get the first cell transplant/neurotrophin combination therapy tested in a clinical trial. I believe that this is the best option.
• Many animal studies have reported treatments that regenerate the spinal cord. The proof that these therapies work in humans will have to come from trying the treatments in humans in well-designed clinical trials. If the treatment doesn't work, we need to demonstrate it rigorously. If it restores function, that would be great. That is what clinical trials are all about.

I disagree with your repeated assertions that we need "proof" that treatments cure animals and then all the money and clinical trials in humans would follow. THE ONLY PROOF is if the treatment works in humans. Let me give you an example. Dr. David Ho got some animal data suggesting that combination anti-virals for AIDS would be much more effective than individual treatments. He wasn't sure that this would be effective in humans. So, he took it to clinical trial and showed that this is true.

We face the same situation in spinal cord injury. Animal data suggest we must address several major obstacles to regeneration in order to get substantial functional regeneration. These obstacles include an injury site that is inhospitable to axonal growth, lack of prolonged growth factor support, and the presence of axonal growth inhibitors such as Nogo.

Mononuclear cells will fill the injury site. Lithium stimulates these cells to produce neurotrophins. Our combination cell transplant-lithium trial will test the first two of the three part combination. It is possible that it may not produce all that much recovery because we have not addressed the third obstacle. We are of course hoping that we will be able to include a nogo or nogo receptor blocker, or chondroitinase in future clinical trials.

Wise.

This is very sad.

I think a majority of the people on this forum believe that you are going to come up with a cure Dr. Young. You give us all hope and reasons to believe even mentioning that "cures will arrive sooner than later" knowing that your trials have been set back. Are you saying that we should have "hope" because of other therapies other than your own?

24 million needs to be raised for a lithium trial? umm I'm thinking is there substantial enough evidence that Lithium is gonna help? Because if there is I don't see a problem with you being able to get that money. I don't know how many times I have mentioned Proof to people and noone seems to get this. There are lots of wealthy people willing to spend money on proof. Nobody want's to spend momey on testing safety. Forget it! Efficacy needs to go hand in hand.

In addition to this,

Is there any reason why anyone of us on carecure should actually believe we are going to be helped at all with this hellish condition? I am not here rambling on there are some things I am working on and there no joke, but I just think I come to carecure to read up about the progress of the cure around the world/planet not to discuss who I am having sex with, in what position, how often I should empty my bladder etc..that is what doctors are for.........

If there is NO HOPE in the near future for a cure why are we all here? This is so confusing Dr. Young, truly. I think you do realize the sense of urgency and I am not saying anything is your fault, I know your doing your thing, but this is truly unacceptable in every which way and meaning of the word. It is NOT FUNNY to not walk.

[adi chicago]

NO ADI-

the science may NOT solve our problem one day. More people are interested in investing in technology. Technology is moving forward at the pace of a skyrocket. Science makes track marks like a snail on the sidewalk.

( very cute avatar BTW )

i think that the politicians stop the reaserch regarding sci and a cure for an unknow reason.are they afraid of me or many others suffering?my spinal cord is damaged my feelings and my brain are still ok.i learned a tough lesson from life .