USC researchers have potentially discovered the secret to treating paraplegic injuries using stem cells.
A team of doctors from the Keck Medical Center of USC have become the first in California to inject a patient with an experimental treatment made from stem cells as part of a multi-center clinical trial.
The patient in question is Kristopher (Kris) Boesen, a 21-year-old who on March 6 last year suffered a traumatic injury to his cervical spine after his car fishtailed on a wet road and slammed into both a tree and telephone pole.
Kris’ parents were told that there was a good chance their son would be permanently paralyzed from the neck down. That was until the Keck Medical Center of USC’s surgical team offered them hope in the form of an injection of an experimental dose of 10 million AST-OPC1 cells directly into Kris’ cervical spinal cord just one month after his accident.
Now nine months after this injection and Kris is one of six patients to have lost all motor and sensory function below the injury site that have shown additional motor function improvement after both six months and nine months of treatment with 10 million AST-OPC1.
The stem cell procedure received by the six patients is part of a Phase 1/2a clinical trial which is evaluating the safety and efficacy of escalating doses of AST-OPC1 cells developed by biotechnology company Biotherapeutics Inc.
The positive efficacy results from this study and the effect it has had on the five patients were announced on January 24 at a press conference held by Biotherapeutics Inc.
The positive results in regards to improvements in upper extremity motor function were measured using the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) scale. The trial saw improvements in Upper Extremity Motor Score and also Motor Level Improvement amongst the six patients.
For the five patients who completed at least six months of follow-up, all five patients saw early improvements in their motor score (UEMS) at three months maintained or further increased through their most recent data point of either six or nine months.
And for patients completing at least six months of follow-up, all five achieved at least one motor level improvement over baseline on at least one side, and two of the five had achieved two motor levels over baseline on at least one side, while one patient achieved a two motor level improvement on both sides.
The trial results reveal a positive safety profile for AST-OPC1, as there have been no serious adverse events from the study which indicates that AST-OPC1 can be safely administered to patients in the subacute period after severe cervical spinal cord injury.
Dr Richard Fessler is the professor in the department of neurosurgery at Rush University Medical Center, one of six centers in the US currently studying this new stem cell treatment.
Dr Fessler said the new treatment was bringing improvements to the patients’ lives involved in the trial: “With these patients, we are seeing what we believe are meaningful improvements in their ability to use their arms, hands and fingers at six months and nine months following AST-OPC 1 administration.
“Recovery of upper extremity motor function is critically important to patients with complete cervical spinal cord injuries, since this can dramatically improve quality of life and their ability to live independently.”