Saturday, November 6, 2010

Living with Spinal Muscular Atrophy - Inspired By Lizzy Boutique hair bows and NIH SMA Workshop





My boutique bows I have made have been quite a success with fundraisers to help with Lizzy's benefits .  I thought I would share some of my bows that will hopefully be on the HOPE and Light Ebay  auction. I am a bit late sending them but we have been very sick here. I did not want to send any nasty viruses to any kids. So my apology to the Millers for not getting them there on time.  Here are some I am donating to the Hope and Light fundraiser.  Where else can you get boutique Hair bows actually made with a grandmother's love?






I thought I would share this from my friend Vinny's facebook page 



by Vincent Gaynor on Saturday, November 6, 2010 at 11:02am
Thank you Vinny!! 

After scouring through 15 hrs or so of footage, I wanted to discuss some of the info that was presented at the NIH SMA Workshop. It is my humble opinion we as a community need to really start to listen, learn and pay more close attention to what is presented to us parents and families in the SMA community. We can no longer take opinions from any organizations, researchers or clinicians as gospel; but we must educate ourselves and take full responsibility to make educated decisions on the research ourselves. We must  look at the data to see if there is a significant life extension in the most severe mouse model and move forward from that point. If there is a significant extension of life, to then continue to move forward and conduct further safety and efficacy studies. If there is not a noticeable increase in life, or there are toxicity issues we must not continue to fund costly trials, rather move into other avenues until we do see a program that is worth funding. For our kids we do not have the time to continue a multiyear trial on a therapy that shows signs of very little hope from the beginning. A minute amount of the current known drugs on the market have been screened for SMN 2 up regulation. If a therapy is showing very little to no promise we must look at screening some of the overwhelming majority of other drugs that are currently available.
It is my opinion that using the term "Responders and Non-Responders" in description of a therapy can be inaccurate and misleading. After all, at this workshop the researchers discussed the vast differences, even amongst a small population within the same phenotype with exact same amount of SMN 2 copies. It was discussed how difficult it would be to see what actual benefit a therapy had since there is so much variation. Thus how can a therapy that showed little to no effect in the disease  mouse model then be correlated to humans and inferred to have responders and non-responders. There currently is no accurate mechanism that can decipher strengths and weaknesses. We must show results first in the mouse model.
At present the best tool we have as a community is the SMA type 1 mouse model to judge potential effectiveness of a therapy. It is not the end all be all of a particular treatment rather an important starting point to see if a therapy is promising enough to merit continued research in a program. I have heard presented that we should move away from the SMA type 1 mouse model as it is too severe. I totally and completely disagree with this notion. It is not the mouse model that is the problem it is the therapy. After all there are now 4 different completely independent labs that have shown significant extension of life in the mouse model in it's current state. The mouse model is severe, just like the disease in type 1 SMA. So if 4 different labs have been able to improve this model, than the model is effective and it shows the promise of those particular avenues of research. We should look for other therapies that can duplicate or improve upon the results these labs have seen.
The Stem Cells and the Gene Therapy were amongst all of the other programs that were discussed at this workshop. In my opinion the "false hopes" of the community regarding the stem cells can be attributed to not what assumptions parents have made rather what has been presented to them. I have never seen the stem cell program referred to anything other than "The Motor Neuron Replacement Program" or MNRP for short. What that title alone infers is that there is a replacement of motor neurons. A regenerative therapy. Yet at the workshop the lead researcher of the MNRP Hans Kierstead informed the audience that the motor neurons he has produced, do not innervate. They are incapable of producing the necessary signals between the spinal cord and the muscles. Rather these motor neurons could possibly offer Trophic support. Meaning they will act as a crutch to existing motor neurons. I have heard parent's being told "the Gene Therapy will only stop the SMA but the Stem Cells are going to Cure SMA". This statement was incorrect and was not substantiated by the lead researcher himself. It was stated that this therapy will be done in end stage patients. Type 1 patients who are not expected to live. Here is my issue with these statements. If the stem cells only possibly offer Trophic support, it does not make sense to move into a patient who in theory has lost most if not all of their motor neurons already. This therapy would have to be administered to presymptomatic or the earliest patients to be effective based on the data that was presented. The researcher also stated that we are many years away from having the capabilities of actually replacing motor neurons. There was zero increase in the lifespan of the type 1 mouse model in this program.
As far as the Gene Therapy when administered early on in the disease it showed a significant increase in the SMA type 1 mouse model. These early treated mice increased from the 15 day life expectancy to upwards of 400 day survival. A monumental improvement in the mouse model that has never been seen before in a viable treatment for SMA. The question is the window of opportunity to get into a patient effectively. In the mouse it was very early however in the non-human primate the motor neurons were targeted effectively from various ages all the way up to 3 years of age. Which maturity wise would correlate to a young child in humans. The difficulty of predicting how this will correlate to humans is that at present time there is not an SMA non-human primate. The only way to tell what actual benefit can be expected in our kids is via clinical trial. This will be a very important trial for our kids. Many questions will be answered in clinic. What is important to understand in theory is that if the Gene Therapy does not work in later type 1 because of significant motor neuron loss... then ANY drug to up-regulate SMN 2 will be ineffective. Based on the motor neuron loss theory; if you are transplanting SMN 1 and the motor neurons are not there, then any drug that up-regulates SMN 2, to mimic SMN 1,  but at a drastically diminished efficiency than the actual SMN 1, will not work either. It is like trying to put gas in a car with no engine. 

We must not rely on others to guide us, rather we must look at the data and let that be what we base our own opinions on regarding therapies for OUR children.

Here is the link for the NIH Workshop. To hear Dr Kaspar speak in his own words fast forward to around 3 hours and 45 minutes. To hear Dr Kierstead speak in his own words fast forward to 4 hours and 31 minutes.

Since the link is a changing link here is the link to all 15 hrs. Dr Kaspar and Dr Kierstead both are in part 3 at the above referenced times!

I am proud to say if you look at the sponsors of the NIH workshop under the logos of FSMA, Fight SMA, MDA and SMA Foundation you will see Miracle for Madison and The Sophia's Cure Foundation. B4SMA was also mentioned! 


"We believe in miracles because we live with one!!"
www.our-sma-angels.com/elizabeth 

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