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

Kumar R 1 , Htwe O 2 , Baharudin A 2 , Rhani SA 3 , Ibrahim K 4 , Nanra JS 5 Show all authors , Gsangaya M 6 , Harun H 7 , Kandar K 8 , Balan M 6 , Peh S 2 , Pokharkar Y 9 , Ingole A 9 , Hisam Ariffin M 2

Affiliations 

  • 1 Neurosurgery Unit, Department of Surgery, Faculty of Medicine, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia
  • 2 Department of Orthopaedics and Traumatology, Faculty of Medicine, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia
  • 3 Department of Orthopaedic, KPJ Selangor Specialist Hospital, Selangor, Malaysia
  • 4 Department of Orthopaedic, KPJ Ampang Puteri Specialist Hospital, Selangor, Malaysia
  • 5 Prince Court Medical Centre, Kuala Lumpur, Malaysia
  • 6 Department of Orthopaedics and Traumatology, Hospital Serdang, Selangor, Malaysia
  • 7 Department of Orthopaedics and Traumatology, Hospital Pengajar Universiti Putra Malaysia, Selangor, Malaysia
  • 8 Department of Orthopaedic, Avisena Specialist Hospital, Selangor, Malaysia
  • 9 Singapore Clinical Research Institute, Singapore, Singapore
J Spinal Cord Med, 2023 Jul;46(4):682-686.
PMID: 35604343 DOI: 10.1080/10790268.2022.2067972

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.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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