Which is the trick?
the point is that hope is a word. I don't like the word too much but I know that you give it to people around the world.
We need to turn that hope and all the thousands of people you have inspired by your words that believe in you and what you say into reality. We must and I mean we must bring chronic clinical trials to the USA ASAP.
Whatever we have to do this, and if there are therapies in the pipeline that really should be tested it must be done now. I will get every single person I know to back this up and be on board if this is truly serious and we are making progress here and if there is real true potential for chronics to have a better quality of life.
Many people email me from around the world asking me what I believe in. I need something to believe in and have the thousands of followers follow what I believe because I have been in search for something real and tangible. I am grateful that you continue to tell us we will walk but let’s let action start to speak my darling. Count me in.
Last edited by spidergirl; 04-30-2009 at 07:44 AM.
Birds Fly in Flocks, but Eagles Fly Alone...
This thread certainly has my attention. I'll be following the progress towards USA clinical trials very closely.
Most rehabilitation doctors don't think that this will not be possible in the United States for a variety of reasons. In Kunming, family members are helping with the walking and they are beginning directly with overground walking using a wheeled walker. In the United States, the rehabilitation centers are currently doing weight-supported treadmill training before progressing patients to overground walking. When I first mentioned in Austin to the doctors and the Open House that we will require everybody in the program to be standing at least an hour a day before they can start the treatment phase, this was a surprise to everybody.
Part of our criteria for entry into the trial is that we want all the subjects to be examined at least 3 times before they can be in our trial. This way we have repeated measure so that all the patients fulfill our definition of chronic spinal cord injury, i.e. more than one year after injury and 6 months of stable neurological function. During that period, we want to ensure that all other factors (such as neuropathic pain, spasticity, etc.) are also stable. In the U.S., we will probably limit the study to only those with ASIA A.
Finally, we have a lot of fundraising and regulatory approval yet to achieve. I estimate that his trial will end up costing about $30 million. We have to raise that money within the next 12 months. We also have to get FDA approval of the trial and I am giving ourselves a year to get the approval. The training of the centers will proceed during the summer. The subjects will be recruited starting October. At the Kunming rehabilitation consensus meeting, the doctors are telling me that they will need to spread out recruitment over a 6 month period or longer to accommodate rehabilitation of 30 subjects. Few centers have the facilities to train so many people at the same time.
I don't know about hope as much as common sense. Common sense tells us that we don't try, nothing will happen. At a recent meeting in Georgia, a quadriplegic man (Irv Naylor) made a very good point. He said that we have a fear of failure that is keeping us from trying. I agree with him. We should not be afraid. We should be setting up the clinical trials, using the best and safest therapies that we can identify. Centers who care should be joining the network, train together to make sure that we can collect credible data, and work with many laboratories to make sure that we have the best therapies.
A lot of people assume that I am doing this because of I want to push umbilical cord blood and lithium. Please understand that we did not invent this therapy. Umbilical cord blood mononuclear cells have been reported by many laboratories to be beneficial models of spinal cord injury but mostly when the cells have been transplanted directly to the spinal cord. These studies were done in China, Japan, Korea, and the U.S.A., and published in peer-reviewed journals. From our own limited experiments with umbilical cord blood mononuclear cells, I am convinced that the cells are safe and that they will bridge the injury site.
Lithium was found by colleagues at the University of Hong Kong to stimulate regeneration in the spinal cord. We found that lithium strongly stimulates umbilical cord blood mononuclear cells (UCBMC) to proliferate and to produce growth factors that stimulate regeneration. Both cord blood and lithium have been used for many years in many patients and have a long and strong record of safe use. HLA-matched cord blood cells are available from cord blood banks. In my opinion, these cells and lithium are the best combination therapy that we can use for the first trial of a therapy for chronic spinal cord injury. If UCBMC and lithium improves function in people with chronic spinal cord injury, that would be wonderful. We will continue to test better therapies. If it doesn't work, that would be important as well because we can say so and stop wasting time pursuing therapies that don't work.
Regarding funding, I am very tired of waiting for some sugar daddy or the government to give the money for the trials. I have now spent the better part of the past decade trying to encourage the government and attending fundraisers to raise money on spinal cord injury clinical trials. It has taken nearly 8 years to get the Christopher and Dana Reeve Paralysis Act to be passed. I have participated in hundreds of fundraisers and little of the money has been spent on clinical trials. So, that is why I have decided to take the bull by the horn and just raise money directly for clinical trials of chronic spinal cord injury. We are not asking for big donations. The goal is to get many people who care about clinical trials for chronic spinal cord injury to give a dollar a day.
Everything you say makes sense. I will begin donating on a monthly basis, more than a dollar a day. No one but us can help us, along with your seemingly tireless efforts.