Geron Gets the Green Light for Phase I Human Clinical Trials
Yes! Geron has received the green light from the FDA to begin the Phase I clinical trials of GRNOPC1 in people with acute (this means people newly injured, and probably in ICU) spinal cord injuries.
This signifies the first time a human embryonic stem cell (hESC)-based therapy will be used on humans (in the United States). Currently other countries such as China and European nations are proceeding with embryonic stem cell therapies, but the documentation on the procedures used and success rates are sketchy.
With FDA approval to proceed in the United States, it will mean that Geron will follow strict guidelines every step of the way. In Phase 1, patients with “complete” injuries will receive the GRNOPC1 therapy. Paraplegics with injuries from the T3 to T10 spinal column will be injected (with their consent) between seven and 14 days after injury to the spinal cord.
“We are pleased with the FDA’s decision to allow our planned clinical trial of GRNOPC1 in spinal cord injury to proceed,” said Thomas B. Okarma, Ph.D., M.D., Geron’s president and CEO. “Our goals for the application of GRNOPC1 in subacute spinal cord injury are unchanged — to achieve restoration of spinal cord function by the injection of hESC-derived oligodendrocyte progenitor cells directly into the lesion site of the patient’s injured spinal cord. Additionally, we are now formally exploring the utility of GRNOPC1 in other degenerative CNS disorders including Alzheimer’s, multiple sclerosis and Canavan disease.”
Safety of the therapy will be assessed as well as the awaited results of improved changes in movement and sensation in the lower extremities and legs.
With the success of this first phase, Geron will extend the study. Newly injured patients with complete cervical injuries, and then patients with severe incomplete (ASIA Impairment Scale grade B or C) injuries, will undergo the therapy. Each phase must meet FDA approval.
U.S. Medical test sites (up to seven) conducting the therapy, will be announced as patients (unlucky but possibly very lucky) are enrolled in the study.
Good luck Geron!
September 26th, 2010 at 12:14 pm
[...] Northwestern will be the lead site for the Geron Phase I clinical trials of GRNOPC1 Human embryonic stem cells therapy for spinal cord injury. This is exciting for the [...]
November 12th, 2010 at 7:44 pm
My son is 28 years old and had a car accident on July 15, 2010.
Due to the accident, he broke 3 vertebrae, C5, C, and C7. The cervical cord was not severed.
Due to his injury he was diagnosed as quadriplegic.
The facility he’s now is providing him with very little therapy. Therefore, the muscles in his arms are atrophyating. Even then with his determination to heal his body, he asks his wife and me to help him to exercise his body, so his right arm is moving, not a lot but it is moving and now the doctor seams to believe that he’s a false quadriplegic.
I will take Arwem (my son) anywhere necessary to help him to achieve his maximum potential with his body.
We don’t have the money, we are using Medicaid to help his rehabilitation costs, but I will try to get loans and do whatever will be necessary to help my son. Unfortunately I am on disability.
Please help my son?
Thank you for reading my plea, I look forward to hear from you so much.
January 5th, 2011 at 5:37 pm
Keep up the good work, Geron. Do you think stem cell research will offer anything for the chronic quads, say of a few years?
April 28th, 2011 at 4:47 pm
Supposedly, yes. They have a solution. Slow process though.
June 26th, 2011 at 12:20 pm
My son is quadriplegia and I would like to learn more about the trials and he would like to volunteer for any futher trials!! He has a C4-5 &6-7 incomplete, his accident was 11-6-09. he can move his arms but has no fine motor skills!Any help with this is GREATLY APPRECIATED!!!!
August 4th, 2011 at 9:29 am
Unfortunately, your son has a chronic longer-term injury, and is currently not eligible for these trials. There are other trials occurring in China which are for chronic injuries. They involve cord blood, and if successful will come to the U.S.