During the first reporting period, the project successfully initiated the clinical study. Four patients were included in the study. Two were randomized to receive surgery with the regenerative treatment followed by rehabilitation physiotherapy training and two were randomized to receive rehabilitation physiotherapy training only. As an integral part in the project, all patients receive physiotherapy training for 18 months. The walking training uses a robotic system that enables intensive functional locomotion therapy. In line with the project plan the installation of a Lokomat walking training robotic system, was successfully performed at Rehabilitation Station Stockholm (RSS) in Sweden. The project has introduced new cutting-edge technology in Sweden, intended for physiotherapeutic rehabilitation of spinal cord injury patients.
During the second reporting period, 4 additional subjects in Sweden were randomized into the study and 3 of these patients received regenerative treatment surgery. Thus, in total 8 subjects had been randomized into the study where 5 subjects received surgery and 3 subjects were controls. The first safety interim analysis was conducted by an independent Data Monitoring Committee (DMC). The DMC, stated that the study may continue according to plan i.e. one additional subject should be included to complete sequence A and thereafter recruitment for sequence B would be initiated. The project had during the second reporting period included clinics in Norway and Estonia.
During the final reporting period, one additional subject from Sweden and one from Estonia were randomized to surgery and both subjects participated in the robotic physiotherapy body weight-supported treadmill training in Sweden and Estonia.
After a favorable safety assessment of the first panel, a pre-specified interim analysis of the efficacy and safety was performed, evaluating the first nine patients who completed the 18 months rehabilitation training. Electrical impulses passing the injured area were not detected in any of the treated patients, which is considered a prerequisite to restore motor function. In addition, there was no improvement in sensory or motor function as measured by the American Spinal Injury Association Impairment Scale (AIS). Results from the self-assessment questionnaires showed that there was a tendency to some temporary reduction in pain in patients treated with SC0806, however, there were no consistent benefits shown by other measurements. The treatment and surgical method showed an acceptable safety profile in the study.
Based on these results it was decided to terminate the Phase 1/2 study of SC0806 and no more patients will be included in the study. The patients still in training, are allowed to complete the 18 months training program.
The study will be closed in a controlled and responsible manner and it will be ensured that valuable knowledge gathered is made accessible to researchers globally. The study results are planned to be submitted for publication in a scientific journal.
