Invivo Therapeutics has provided an update on the progress of the company’s INSPIRE study (Invivo Study of Probable Benefit of the Neuro-Spinal Scaffold for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury), which is designed to demonstrate the safety and probable benefit of the Neuro-Spinal Scaffold for the treatment of complete thoracic spinal cord injury (SCI).
The primary endpoint of the study is defined as improvement in ASIA Impairment Scale (AIS) grade from baseline at the six-month visit.
The study update includes:
- One patient improved from complete AIS A SCI to motor incomplete AIS C SCI at the one-month visit.
- A second patient improved from complete AIS A SCI to sensory incomplete AIS B SCI at the six-month visit.
- Six of 11 patients (54.5 %) have had an AIS grade improvement at the six-month primary endpoint visit.
| Patients Currently in Follow-Up | |||
| Patient Group | Number of Patients | ||
| Converted at six-month visit | 6 | ||
| Converted, less than six months of follow-up | 1 | ||
| Not converted at six-month visit | 5 | ||
| Not converted, less than six months of follow-up | 4 | ||
| TOTAL | 16 patients in follow-up | ||
- Of the seven conversions, four are AIS C conversions at this time, meaning these four patients have recovered both sensory and motor function. These conversions to AIS C have occurred as early as one month and as late as 24 months after Neuro-Spinal Scaffold Having assessments of motor improvements occurring one or two years post-implantation is uncommon and may be indicative of prolonged neural repair.
One of the two patients who recently converted was implanted with the Neuro-Spinal Scaffold in January 2017 by Travis Dumont, director of the Neurovascular Program and Principal Investigator at Banner – University Medical Center Tucson in Tucson, USA. This patient initially converted from complete AIS A SCI to sensory incomplete AIS B SCI at two months but reverted back to AIS A at three months. Subsequently, at the six-month visit, the patient converted from AIS A to AIS B. This conversion to AIS B at six months will be included in the primary endpoint analysis of AIS improvements from baseline at the six-month visit.
Dumont says, “This patient has demonstrated motor improvements from baseline assessments, and the conversion to AIS B at the six-month visit is encouraging.”
The other patient who recently converted was implanted in June 2017 by Dan Altman, Nestor Tomycz, and Terrence Julien at Allegheny General Hospital in Pittsburgh, USA. The patient converted from complete AIS A SCI to motor incomplete AIS C SCI between the hospital discharge and one-month visits. At baseline, the patient was assessed to have a T6 neurological level of injury (NLI).
This is the second patient in the INSPIRE study to have reached AIS C motor incomplete classification at the one-month evaluation and the fourth patient in the INSPIRE study to have reached AIS C motor incomplete classification.
Julien, system co-director of Minimally Invasive Spine Surgery and principal investigator, says, “A conversion to AIS C at one month for a patient with a T6 level of injury is rare. I look forward to continuing to track the patient’s progress and hope that the patient continues to show signs of neurological recovery.”
