I want combo trials, and now!!

[quadfather]

In a recent post Dr. Young stated: "Several combinations of therapies have been reported very recently (these studies have not even been published yet) to produce dramatic regeneration and recovery of function in animals".

1. When will these results be published?
2. Why the delay?
3. What steps can I take to move these therapies from research bench to the operating room?

[Christopher Paddon]

i reckon these combination therapies will be the closest thing to a "cure" so far

i wouldn't mind betting that money is the main missing ingredient

was it on carecure that i saw a cartoon of a little girl who used a wheelchair reading the paper "they want $3 trillion so men can walk where?" she asks

[Wise Young]

Quadfather, it takes months for papers to be published. The results have been reported in meetings only. The manuscripts are peer-reviewed and then published. Publications often lag behind reporting by 6-12 months. However, many laboratories are working on combination therapies right now.

The current situation regarding clinical trials is very cumbersome. To get a combination therapy into clinical trial going, we must now go through a three-step process. First, one must organize a clinical trial team to do the trial. Second, one must get each therapy developed to the point that it is safe to apply the therapy to people. Third, one must raise the funds of the trial.

Having a clinical trial network will make step 1 and step 3 shorter and easier. It means that there is an organized group of clinicians who are ready to conduct the clinical trial. The infrastructure for the clinical trial does not have to be built up from scratch everytime one has a therapy to test. It also means that there will be money for the clinical trial.

It is so important that the spinal cord injury community understand this. Too many people think that doing a clinical trial is just sprinkling therapy on people. It takes years to organize the clinical trial team, to gain access to the therapies, and then to raise the moeny to carry out the trial. We need to short-cut this with a clinical trial network.

What I am saying here is not new nor unusual. The people in the cancer field knew this in the 1970's, when Nixon declared the "war on cancer" and the first thing that they did was to create Centers of Excellence for cancer therapy that are constantly randomizing patients to the best experimental therapies compared to the best standard therapies.

Wise.

[This message was edited by Wise Young on 04-12-04 at 12:41 AM.]

[Schmeky]

quadfather,

Even if a cure were developed RIGHT NOW, by the time it was peer reviewed and published, made it through the approval process, then cleared all the FDA clinical trials, you're looking at 7 years at best, 12 on average, and as long as 15 years before you and I could benefit.

Sucks [img]/forum/images/smilies/mad.gif[/img]

[Isildur]

i desagree with you schmeky thing will go faster than we think, if the cure will discovered tomorrow won´t must wait more than a year to can get the procedure. LOT OF PEOPLE AND ASOCIATIONS ARE WAITING FOR CURE AND HIS PRESSION MAKE THE STEPS MORE EASY AND FASTER

excuse my english

[Wise Young]

information exchange is occurring before the papers are published. That is how and why people here know about these findings about combination therapies. Scientists are working on it. The obstacles of the FDA, publication, and other things are the same obstacles that all other fields face and there are ways of shortcutting around these obstacles if a network is established. The scenario that you describe is a little too pessimistic even for me.

Wise.

[Schmeky]

Dr. Young,

I am thrilled that you think my analogy is overly pessimistic. HOWEVER, the information I posted is from a Reeve-Irvine Research Center newsletter I recieved last summer that detailed the clinical trial process in the US.

Didn't want you to think I was pulling this out of the air.

[quadfather]

Originally posted by Wise Young:

information exchange is occurring before the papers are published. That is how and why people here know about these findings about combination therapies. Scientists are working on it. Wise.

Can you be more specific? Especially in scope (i.e. which is getting the most attention from researchers, how many labs? how many different combos?)

[Christopher Paddon]

Quad - i sure hope so - i can't wait much longer

[Wise Young]

quadfather,

It is hard to give a specific number. I can tell from the buzz at the meetings. Almost every spinal cord injury laboratory that I know is now making combination therapies a high priority. I don't know how many are actually doing it. Many laboratories that are doing cell transplants are considering giving some other therapy alongside the cell transplants, for example. I have given two examples of laboratories that have reported that combinations of therapies are better than the individual therapies alone: Mary Bunge's laboratory at Miami Project and Xiao Ming Xu's lab in Louisville. I know that our laboratory has shifted our focus to combination therapies. I think that the Reeve-Irvine Center is doing combination therapies. There must be dozens more examples.

Wise.

[DA]

Originally posted by Wise Young:

quadfather,

It is hard to give a specific number. I can tell from the buzz at the meetings. Almost every spinal cord injury laboratory that I know is now making combination therapies a high priority. I don't know how many are actually doing it. Many laboratories that are doing cell transplants are considering giving some other therapy alongside the cell transplants, for example. I have given two examples of laboratories that have reported that combinations of therapies are better than the individual therapies alone: Mary Bunge's laboratory at Miami Project and Xiao Ming Xu's lab in Louisville. I know that our laboratory has shifted our focus to combination therapies. I think that the Reeve-Irvine Center is doing combination therapies. There must be dozens more examples.

Wise.

this great news. finally corners are being cut.

[DA]

i was so wrong...

[Emi2]

I finally read something in cure, get hopeful and then read the dates....gah. 6 years....and what?

[DA]

I finally read something in cure, get hopeful and then read the dates....gah. 6 years....and what?

seeee, when i point out how nothing has changed, then you have jim, 55, and others screaming shut up and smile.

here is dr young from 2004

07-25-2004, 07:34 PM
1. rolipram and db cAMP
a. with Schwann cells (Bunge, et al, Miami)
b. with bone marrow stem cells (Tuszynski, et al., UCSD)
2. GDNF and chondroitinase with Schwann cells (Xu, et al., Louisville).
3. L1 with radial glial cells (Grumet, et al., Rutgers)

All of these have several significant obstacles to clinical trial both in the United States and around the world. First, none of the studies gave the treatments to chronic spinal cord injury and some animal data will probably be required before the combinations will be tried in chronic human spinal cord injury. Second, it may take a little time to negotiate the drugs from their sources: chondroitinase is available from Seikagaku and possibly from Acorda Therapeutics, db cAMP is just a common chemical, and GDNF should be available from Amgen. Third, the sources of the cells will require a lot of work. Finally, we need to find a funding source for these trials. I suspect that these obstacles will require at least a year or two to overcome.

Wise.

[mckeownp]

plese watch this. DVD I think Late May

Can you be more specific? Especially in scope (i.e. which is getting the most attention from researchers, how many labs? how many different combos?)

Harrison Ford Movie...Extraordinary Measures Sir.