First-in-human clinical study found improved motor and sensory function in three of four participants
Writing in the June 1 issue of Cell Stem Cell, researchers at University of California San Diego School of Medicine report that a first-in-human phase I clinical trial in which neural stem cells were transplanted into participants with chronic spinal cord injuries produced measurable improvement in three of four subjects, with no serious adverse effects.
GEORGINA Fiorentino thought her life was over when she lost feeling in her legs and became reliant on a wheelchair.
“You go through a whole process in your mind that it’s all too hard,” the Essendon North resident said.
“A lot of people have no idea the bits and pieces that follow on from a spinal injury.
“There are so many other things that are affected that are worse than not being able to walk.”
The Miami Project to Cure Paralysis, a Center of Excellence at the University of Miami Miller School of Medicine, has received permission from the Food and Drug Administration to begin a Phase 1 clinical trial to evaluate the safety of transplanting human Schwann cells to treat patients with recent spinal cord injuries.
We are not recruiting anybody until we obtain approval from our Institutional Review Board.
This trial is just 1 brick in the wall. We will continue working with our scientific colleagues to test other “bricks” in the wall to ultimately develop a strong defense to prevent or reverse the many effects of paralysis.
Northwestern Medicine is the first site open for enrollment in a national clinical research trial of a human embryonic stem cell-based therapy for participants with a subacute thoracic spinal cord injury. Following the procedure, participants will receive rehabilitation treatment at The Rehabilitation Institute of Chicago (RIC).
Northwestern also is the lead site of the trial, sponsored by Geron Corporation (Nasdaq: GERN). The trial eventually will include up to six other sites and enroll up to 10 participants nationally.
This site is designed primarily to allow family, friends, andsupporters of Matt Courson a means to keep up with his treatment andrecovery efforts from a level T8 Spinal Cord Injury (SCI) he sustainedfrom an ATV accident in the spring of 2006.
We are a part of a global community in which the devastation of spinal cord injury (SCI) bows to no flag, and solutions will not be any country’s exclusive domain. Integrating the diverse pieces of the puzzle necessary to develop real-world solutions requires that we open-mindedly work in cooperation and not in competition. With such cooperation, restored function after SCI will be a coalescing reality and not just a never-ending, elusive pie-in-the-sky dream.
In this spirit of bridge-building, I recently traveled to Moscow, Russia where I became the first American scientist to check-out an innovative stem-cell program for SCI developed by the NeuroVita Clinic under the direction of Dr. Andrey Bryukhovetskiy. His work is especially important because few scientists have accumulated as much hands-on experience as he has in treating human SCI with stem cells, an approach many experts believe will play a key therapeutic role in the future.