Long-Term Outcomes of the Spinal Cord Injury Assessing Tolerability and Use of Combine Rehabilitation and NeuroAID (SATURN STUDY)

Abstract

Background: Spinal cord injury (SCI) is a devastating neurological disorder that affects thousands of individuals each year. Recent advances in research have given us greater understanding of the molecular and cellular events in SCI.The latest frontier in research involves neuroprotection, repair and regeneration. This paper aims to evaluate the effects of the initial 6-month treatment with MLC601/MLC901 on long term outcomes at 12 months,18 months and 24 months. Methods: The study was an open label, prospective, cohort trial of MLC601/MLC901 (NeuroAiD) in subjects with moderate to severe SCI. Patients age was 18 to 65 years old, and the SCI occurs within 3 days and 4 weeks. Each received MLC601/MLC901 for 6 months in addition to standard care and rehabilitation. Key endpoints were safety, American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade and AIS motor scores at month 6 (M6). The protocol and the primary results of the 6 th month period were previously published. The primary result showed safety and potential role of MLC601/MLC901 in moderate to severe spinal cord Injury. Outcomes of the long-term follow up was assessed up to 24 months. Results: Long term follow-up after 6-month treatment showed durability of improvement in total motor, sensory and SCIM score .The improvement was maintained until 12, 18 and 24 months. Conclusion: The long-term outcomes further provided evidence in the safety and potential role of MLC601/MLC901 in SCI. This findings should help plan a study design for a randomized controlled trial.