InVivo Therapeutics revealed findings from its Contemporary Thoracic SCI Registry Study.
The study is intended to offer comprehensive natural history benchmarks for Neuro-Spinal Scaffold clinical study results. It leveraged neurological recovery data from spinal cord injury patient registries, which have similar baseline characteristics to those in the Inspire study. The study focused on patients with T2-T12 neurological level of injury.
The Contempo Registry Study included data for 170 patients from three SCI registries: North American Clinical Trials Network, European Multicenter Study about Spinal Cord Injury and Spinal Cord Injury Model Systems.
Contempo Principal Investigator James Guest, MD, PhD, presented the findings at the 2018 Spine Summit in Orlando, Fla. Dr. Guest is a neurological surgery professor at the Miller School of Medicine and the Miami Project to Cure Paralysis.
Here are four insights:
1. AIS conversion rates at about six months post-injury differed among the registries from 16.7 percent to 23.4 percent.
2. Two of the registries had 46 percent to 47 percent of the patient population with low thoracic injuries of T10-T12. Only 25 percent of the patients in the Inspire study follow-up had low thoracic injuries. In the Inspire study and the three registries, the low thoracic injury patients had the highest conversion rates.
3. After researchers normalized the three registries to the Inspire patient population distribution across the T2-T5, T6-T9 and T10-T12 injury groups, they recorded the normalized conversation rate for Contempo registries between 15.5 percent and 20.6 percent.
4. The Contempo Registry Study results validated the Inspire Objective Performance Criterion of 25 percent.
"The Contempo study represents a valuable compilation of neurological recovery data from three established SCI registries. This compilation, which is first of its kind, can help guide the development of future clinical trial protocols and aid in the interpretation of the safety and potential clinical benefit of new therapies," said Dr. Guest.