If you’ve been following the Stem Cellar blog this year, then you must be as encouraged as we are with Asterias Biotherapeutics’ CIRM-funded clinical trial, which is testing an embryonic stem cell-based therapy for spinal cord injury.
Over many months, we’ve covered the company’s string of positive announcements that their cell therapy product – called AST-OPC1 – appears safe, is doing what is it’s supposed to after injection into the damaged spinal cord, and shows signs of restoring upper body function at 3 and 6 months after treatment. We’ve also written about first-hand accounts from some of the clinical trial participants who describe their remarkable recoveries.
That streak of good news continues today with Asterias’ early morning press release. The announcement summarizes 9-month results for a group of six patients who received an injection of 10 million AST-OPC1 cells 2 to 4 weeks after their injury (this particular trial is not testing the therapy on those with less recent injuries). In a nut shell, their improvements in arm, hand and finger movement seen at the earlier time points have persisted and even gotten better at 9 months.
Two motors levels = a higher quality of life
These participants sustained severe spinal cord injuries in the neck, leading to a loss of feeling and movement in their body from the neck down. To quantify the results of the cell therapy, researchers refer to “motor levels” of improvement. These levels correspond to an increasing number of motor, or movement, abilities. For a spinal cord injury victim paralyzed from the neck down, recovering two motor levels of function can mean the difference between needing 24-hour a day home care versus dressing, feeding and bathing themselves. The impact of this level of improvement cannot be overstated. As mentioned in the press release, regaining these abilities, “can result in lower healthcare costs, significant improvements in quality of life, increased ability to engage in activities of daily living, and increased independence.”
With the new 9-month follow-up data, the clinical researchers have confirmed that 3 out of the 6 (50%) patients show two motor levels of improvement. This result is up from 2 of 6 patients at the earlier time points. And all six patients have at least one motor level of improvement up through 9 months post-treatment. Now, make no mistake, spontaneous recovery from spinal cord injuries does occur. But historical data collected from 62 untreated patients show that only 29% reached two motor levels of improvement after 12-months.
As you can imagine, the Asterias team is optimistic about these latest results. Here’s what Chief Medical Officer, Dr. Edward Wirth had to say:
“The new efficacy results show that previously reported meaningful improvements in arm, hand and finger function in the 10 million cell cohort treated with AST-OPC1 cells have been maintained and in some patients have been further enhanced even 9 months following dosing. We are increasingly encouraged by these continued positive results, which are remarkable compared with spontaneous recovery rates observed in a closely matched untreated patient population.”
Equally encouraging is the therapy’s steady safety profile with no serious adverse events reported through the 9-month follow up.
Dr. Jane Lebkowski, Asterias’ President of R&D and Chief Scientific Officer, will be presenting these data today during the International Society for Stem Cell Research (ISSCR) 2017 Annual Meeting held in Boston. Asterias expects to share more results later this fall after all six patients complete their 12-month follow-up visit.
The clinical trial is also treating another group of patients with a maximum dose of 20 million cells. The hope is that this cohort will show even more effectiveness.
For the sake of the more than 17,000 people who are incapacitated by a severe spinal cord injury each year, let’s hope the streak of good news continues.