FDA approves Geron Corp. clinical trial for spinal cord injury treatment

Irvine, Calif., Jan. 23, 2009 A therapy developed at UC Irvine that made paralyzed rats walk again will become the world’s first embryonic stem cell treatment tested in humans.

The U.S. Federal Drug Administration has approved the therapy, based on work by a research team led by Hans Keirstead, co-director of the UCI Sue and Bill Gross Stem Cell Research Center, for a clinical trial in patients with acute spinal cord injury.

Geron Corp. of Menlo Park, Calif., will conduct the clinical trial.

“This trial was approved only after rigorous safety testing and consultation of countless experts in the field,” Keirstead said. “Any benefit to the patient, even an incremental one, would be a resounding victory.”

The therapy contains human embryonic stem cells destined to become spinal cord cells called oligodendrocytes. These are the building blocks of myelin, the biological insulation for nerve fibers that is critical for maintaining electrical conduction in the central nervous system. When myelin is stripped away, through injury or disease, paralysis can occur.

In laboratory tests, Keirstead and his colleague, Dr. Gabriel Nistor, developed a technique for prompting human embryonic stem cells to develop into oligodendrocyte cells.

Injected into rats with spinal cord injuries, the precursor cells turned into oligodendrocytes and migrated to the injured area of the spinal cord. As the cells wrapped around damaged neurons, new myelin tissue formed, allowing electrical conduction to resume and the rats to walk again.

Here is the rest of the article. http://www.genengnews.com/news/bnitem.aspx?name=48521033

 Matt met Dr. Keirstead at Project Walk and then again at Working 2 Walk in Washington D.C. This is a day of great hope and promise for spinal cord injury patients. The door is opened now for chronic injuries.

To read more about this breakthrough research from the Christopher Dana Reeves Foundation,   click here .

Another good article on the stem cell issue which quotes Congressman Langevin. Click here.

Many of you might remember my friend Alex Malarkey from Ohio. Alex is a 10 year old boy who has a C1 level spinal cord injury. Earlier this past year I sent Alex my baseball glove to boost his spirits. Alex then returned the favor by sending me a video back of him and his brother singing ‘Take Me out to the Ballgame’, which then boosted my spirits ( http://www.godtube.com/view_video.php?viewkey=5695d58fd136adda770c ).

Today Alex made history. With Alex’s spinal cord injury being so high, he relies on a ventilator to breathe. Alex made a huge leap at getting off of the ventilator, as he was implanted with a diaphragm pacing system by Dr. Raymond Onders. This implantation will hopefully allow him to breathe on his own. Alex is the youngest individual to have this surgery. Christopher Reeve was amongst the individuals who went through this surgery. This surgery will allow Alex to not have to worry about having to make special precautions to breathe when occurrences happen, such as the loss of power. This will also allow Alex to regain his sense of smell. Can you imagine not being able to smell and regaining that? This is amazing!!! With the ventilator, no air goes through the nose or mouth. This will allow Alex to smell again, which is awesome.

I can’t express how proud of Alex I am today. He is an unbelievable kid and I feel so blessed to share a friendship with him. Although Alex is making history today, I guarantee you that he will be making more history in the future through his endeavors. I hope all of you will keep Alex in your prayers for his success. In concluding this post I would like to share a quote from Alex about why he is excited… “So I can breathe by myself,” the fifth-grader said from his wheelchair, after arriving in Cleveland Thursday afternoon. “And I want to be able to smell a good plate of spaghetti.” ( http://blog.cleveland.com/medical/2009/01/boy_undergoes_christopher_reev.html )

God Bless,

Matt C

Here is a video of Alex:

http://www.godtube.com/view_video.php?viewkey=62082a74128c7e936074