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

Ramesh Kumar, Ohnmar Htwe, Azmi Baharudin, Shaharuddin Abdul Rhani, Kamalnizat Ibrahim, Jagdeep Singh Nanra, Muhindra Gsangaya, Hezery Harun, Khairrudin Kandar, Maatharasi Balan, Shawn Peh, Yogesh Pokharkar, Abhinay Ingole, Mohammad Hisam Ariffin, Ramesh Kumar, Ohnmar Htwe, Azmi Baharudin, Shaharuddin Abdul Rhani, Kamalnizat Ibrahim, Jagdeep Singh Nanra, Muhindra Gsangaya, Hezery Harun, Khairrudin Kandar, Maatharasi Balan, Shawn Peh, Yogesh Pokharkar, Abhinay Ingole, Mohammad Hisam Ariffin

Abstract

Objective: MLC601/MLC901 has demonstrated neuroprotective and neuroregenerative properties that enhance neurological recovery in stroke and traumatic brain injury. We aimed to evaluate its safety and potential efficacy in patients with severe spinal cord injury.

Methods: Patients with American Spinal Injury Association (ASIA) Impairment Scale (AIS) A and B were included in an open-label cohort study. Each received a course of MLC601/MLC901 for 6 months in addition to standard care and rehabilitation. Key endpoints were safety, AIS grade and motor scores at month 6 (M6).

Results: Among 30 patients included (mean age 42.2 ± 17.6 years, 24 men), 20 patients had AIS A while 10 patients had AIS B at baseline. Ten patients experienced 14 adverse events including one serious adverse event and six deaths, none were considered treatment-related. AIS improved in 25% of AIS A and 50% of AIS B. Improvement in ASIA motor score was seen most with cervical injury (median change from baseline 26.5, IQR: 6-55). These findings appear to be better than reported rates of spontaneous recovery for SCI AIS A and B.

Conclusion: MLC601/MLC901 is safe and may have a role in the treatment of patients with SCI. A controlled trial is justified.

Trial registration: ClinicalTrials.gov NCT02537899.

Keywords: American Spinal Injury Association Impairment Scale; MLC601; MLC901; Recovery; SATURN study; Spinal cord injury.

Figures

Figure 1
Figure 1
Consort diagram of patient flow.
Figure 2
Figure 2
AIS grading at baseline and months 1, 3 and 6 of SATURN patients (n = 30). Numbers on the bars refer to number of patients with AIS grade.

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Source: PubMed

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