Embryonic Stem Cell Human Clinical Trials in the U.S.
Last week, the FDA held meetings to discuss the implications of future human clinical trials using embryonic stem cells in the U.S. Their meeting titled, “Considerations for Safety Testing for Cellular Therapy Products Derived From Human Embryonic Stem Cell”, is just one step of many, in an area of research that is controversial, exciting, and relatively unexplored.
I’ve been spinal cord injured for almost fourteen years. It’s refreshing to finally see therapies moving from making rats and mice walk, to potentially help some like myself walk again.
The Student Society for Stem Cell Research comments, ‘The FDA hearings are particularly timely, as Geron is expected to begin human clinical trials using embryonic stem cells for the treatment of spinal cord injury this summer.
“We are talking about weeks, not years, before we see the first clinical trials using embryonic stem cells. This is inspiring to our generation and empowers our hope that the next generation will not have to endure many of today’s dreaded conditions for which stem cell research holds promise,” said Marion J. Riggs, SSSCR Founder.’
The human clinical trials proposed by Geron will be conducted on “acute”, or newly injured individuals.
May 28th, 2008 at 11:07 am
how can my daughter be considered a candidate? 3 yrs post injury, 24 yrs old , c-5 incomplete?
May 28th, 2008 at 7:11 pm
Hi Jennifer,
The first trials will only involve those individuals with new “acute” injuries. Your daughter is in the same category as me, and considered to have a “chronic” injury. We’ll have to wait for the first trials to be completed to see what the results are.
The good news is that I was told the therapy should work for “chronic” injuries too. I would imagine when all is said and done, that the procedures used will be a collaboration of a few techniques.
June 3rd, 2008 at 11:52 am
I am in a similiar situation, I have an incomplete spinal cord injury and have hemiparesis on my right side. I really am glad that I have recovered to this degree but feel that I would be a great candidate for a trial such as this. Is there a phase 2 trial possibly or another study that I could find out about becoming a candidate for? Is there somewhere that I could find out about trials and the research that is being done at this time to see when and where the liklihood of any type of treatment may become available. I am lacking fine motor skills in my right side so I am sure that my case might be easier than an acute injury. Is ther a reason why they would not choose an easier case before one like mine? I appreciate your time in reading my response and look forward to whatever information you can provide to me. Thanks Dave Johnson
June 7th, 2008 at 8:07 am
My grandson was just recently injured. Crushed L1 and currently is limited mobility, no bowel or bladder control. He is 16 years old, might he be considered?
June 7th, 2008 at 2:30 pm
David and Paul,
First, the FDA is going to have to give the green light to Geron to proceed. The recent “clinical hold” they enforced on Geron, means no trials will start until the FDA decides how they’re going to monitor the therapy. To gain more insight on the political struggle for a cure, I’d suggest reading stemcellbattles.com.
As for the how the trials will work, and who will be candidates, I invite you to read this post, entries #1, 11, 13, and 17. Entry 13 refers to the therapy I’ve written about.
http://sci.rutgers.edu/forum/showthread.php?t=98549&page=2
June 10th, 2008 at 10:00 am
I am 1yr 6m post T-9 incomplete para. I have regain a lot of movement and still improving a little. I would say I’m in the middle stage but would I be a canidate?
June 10th, 2008 at 8:50 pm
Hi Jeremy,
If the results of the initial therapy are successful on the newly injured, they’re planning on moving it to chronic injuries, like you and me. Cross your fingers.
August 9th, 2008 at 8:28 pm
I had a blood clot that bled out at t-3 and left me paralized from the chest down in May 2008. How can I see if I qualify for this clinical trial?
August 25th, 2008 at 7:38 pm
Hi. I am 6 weeks post injury with my injury being T6 and complete. Is this considered chronic or acute? If it is acute, how do I get involved in clinical trials?
September 26th, 2008 at 6:34 am
i wish the stem cell clinical testing on humans start, i believe that if it can help injured backbones it will definitely work on injured kidneys. i pray that it push through. it will give hope to people around the world sick of chronic illnesses.
October 21st, 2008 at 3:33 pm
Comments are closed.
My guess is that we’ll hear nothing until after the U.S. President is elected.
Mike