Clinical Trial of Stem Cell Therapy Restores Arm, Hand Movement for Paralyzed Man

By: Melissa D. Carter, Attorney at Law

According to the National Spinal Cord Injury Statistical Center, each year, there are approximately 17,000 new cases of spinal cord injury in the United States, with motor vehicle collisions being the leading cause.[1]  A spinal cord injury, or “SCI,” is an insult to the spinal cord resulting in a change, either temporary or permanent, in the cord’s normal motor, sensory, or autonomic function. Patients with spinal cord injury usually have permanent and often devastating neurologic deficits and disability.

Many scientists are increasingly optimistic that advances in research will someday make the repair of spinal cord injury possible, based on current research findings ongoing around the world. A recent clinical trial has seen positive outcomes that may lead to allowing many people with a spinal cord injury to enjoy more productive, independent lives.

One young man and a team of researchers from Keck Medical Center at University of Southern California (USC) are the latest example of how the emerging fields of neurorestoration and regenerative medicine may be on track to improve the lives of thousands of people who have suffered a severe spinal cord injury.

21-year old Kristopher Boesen was paralyzed from the neck down and required assistance to simply breathe on his own following a catastrophic injury from a motor vehicle collision in March, 2016.  Spinal cord injury patients typically undergo surgery to stabilize the spine, but generally cannot restore motor or sensory function.  His medical team sent him to the Neurorestoration Center at USC for an experimental stem cell treatment in April, overseen by Dr. Charles Liu.  The result was jaw dropping: Mr. Boesen regained the use of his arm and hand.[2]

The experimental injection procedure involved 10 million AST-OPC1 cells directly into Mr. Boesen’s damaged cervical spinal cord. The experimental study tested a procedure that could improve neurological function, remove the permanency of a paralysis diagnosis and significantly improve the daily lives of patients with severe spinal injuries.

The stem cell injection procedure was in group, “Phase 2,” of a clinical trial called SCIStar[3]  that is currently looking at the safety and efficacy of escalating doses of AST-OPC1 cells developed by Fremont, California based Asterias Biotherapeutics.  AST-OPC1 cells come from embryonic stem cells by carefully converting them into oligodendrocyte progenitor cells (OPCs), which are found in the brain and spinal cord that support the healthy functioning of nerve cells.  Prior studies have shown AST-OPC1 cells to produce neurotrophic factors, to stimulate vascularization and induce remyelination of denuded axons.  These are all critical factors in the survival, regrowth and conduction of nerve impulses through axons at the injury site, per Asterias.

In 2009, President Barrack Obama lifted the restriction on embryonic stem cell research imposed by former President George W. Bush, allowing American scientists to further the work in the area of stem cell research and medical advancements.

Two weeks after his injection, Mr. Boesen began to show signs of improvement.  Within three months, he was able to use his arms and hands to hug his friends and family, feed himself, use his cell phone, write his name and operate his motorized wheelchair.

The SCIStar trial released early results in September, 2016, which are encouraging.  The sample is still very small and, beyond Mr. Boesen, has shown positive outcomes for other enrollees as well.  The current sample includes two groups of patients (“Phase 1” and “Phase 2”) whom have all lost all movement below their injury site and experience severe paralysis of the upper and lower limbs.  The Phase 1 group consists of three people who received a dose of 2 million stem cells; the Phase 2 group has five people who received a dose of 10 million stem cells.  The first group reported one improved upper extremity motor level on one side of the body in one patient, and one improved upper extremity motor on both sides in the other two patients.  The second group saw two improved motor levels on both sides in four patients and two levels of improvement on one side in two patients.  The fourth patient in the second group improved one level on one side.  There are no measurable negative side effects in any of the participants to date.[4]

Beyond Keck Medicine of USC, additional participants in this ongoing clinical trial include Indiana University in Indianapolis; Medical College of Wisconsin in Milwaukee; Rush University Medical Center in Chicago; Shepherd Center in Atlanta; and Stanford University/Santa Clara Valley Medical Center in California.  To qualify for participation in the experimental clinical trial, enrollees must be 18 to 69 years old, in stable condition and between 14 and 30 days following the injury.  All locations are currently recruiting.

The next round of data will be released at the six-month mark in January, 2017.  To follow this study and its tracked results, visit the SCIStar group at www.ClinicalTrials.gov.

If you would like more information related to spinal cord injury, including treatment options, insurance coverages, and rehabilitation locations, please contact the attorneys at Adler Giersch, PS.

 


[1] https://www.nscisc.uab.edu/Public/Facts%202016.pdf

[2] https://stemcell.usc.edu/2016/09/07/paralyzed-man-regains-use-of-arms-and-hands-after-experimental-stem-cell-therapy-at-keck-hospital-of-usc/

[3] https://clinicaltrials.gov/ct2/show/study/NCT02302157?term=NCT02302157&rank=1

[4] https://ww2.kqed.org/futureofyou/2016/09/12/stem-cells-may-have-restored-use-of-hands-and-arms-in-paralyzed-man/