Spinal cord injury – assessing tolerability and use of combined rehabilitation and NeuroAiD (SATURN) study – primary results of an exploratory study

The Journal of Spinal Cord Medicine, 2023 · DOI: 10.1080/10790268.2022.2067972 · Published: May 10, 2022

Spinal Cord Injury Neurology Rehabilitation

Simple Explanation

This study explores the safety and potential benefits of adding a drug called MLC601/MLC901 (NeuroAiD) to standard care and rehabilitation for people with severe spinal cord injuries. The study found that MLC601/MLC901 was safe and that some patients showed improvements in their condition, suggesting it might help with recovery. The researchers suggest that further, more controlled studies are needed to confirm these findings and see how well the drug truly works.

Study Duration

6 Months

Participants

30 patients with severe spinal cord injury (ASIA Impairment Scale A and B)

Evidence Level

Level 3; Open-label cohort study

Key Findings

1
MLC601/MLC901 was found to be safe as an add-on treatment in severe SCI, with no adverse events considered related to the drug.
2
A third of the patients with severe SCI treated with MLC601/MLC901 improved on AIS grading with corresponding motor recovery by month 6.
3
Improvement in ASIA motor score was most pronounced in patients with cervical spinal cord injuries.

Research Summary

This open-label exploratory study assessed the tolerability and potential efficacy of MLC601/MLC901 (NeuroAiD) combined with rehabilitation in patients with severe spinal cord injury (SCI). The study included 30 patients with ASIA Impairment Scale (AIS) A or B, who received MLC601/MLC901 for 6 months in addition to standard care. Safety and improvements in AIS grade and motor scores were evaluated. The findings suggest that MLC601/MLC901 is safe and may have a role in treating patients with SCI, warranting future controlled clinical trials.

Practical Implications

Potential Therapeutic Agent

MLC601/MLC901 may be a potential therapeutic agent for improving outcomes in patients with severe SCI, particularly when combined with standard rehabilitation.

Justification for Controlled Trials

The observed improvements in AIS grade and motor scores justify conducting future controlled clinical trials to rigorously evaluate the efficacy of MLC601/MLC901.

Enhanced Recovery Strategies

The study supports the exploration of combination therapies involving neuroprotective and neuroregenerative agents like MLC601/MLC901 alongside traditional rehabilitation for SCI.

Study Limitations

1
Open-label design without a control group limits the ability to definitively attribute improvements to MLC601/MLC901.
2
Relatively small sample size (n=30) may limit the generalizability of the findings.
3
Missing AIS grade or ASIA motor scores were imputed by the last observation carried forward, which could introduce bias.

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