Evidence map›Paper›PMID 35604343›Full record

Trial reportThe journal of spinal cord medicine2023

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 and 4 more

Open access · hybridAbstract readClinical Trial
In one paragraph

Trial report in The journal of spinal cord medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
1.2field-weighted citation impact, top 23% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 5 institutions in 2 countries.

Ramesh KumarNeurosurgery Unit, Department of Surgery, Faculty of Medicine, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia.
Ohnmar HtweDepartment of Orthopaedics and Traumatology, Faculty of Medicine, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia.
Azmi BaharudinDepartment of Orthopaedics and Traumatology, Faculty of Medicine, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia.
Shaharuddin Abdul RhaniDepartment of Orthopaedic, KPJ Selangor Specialist Hospital, Selangor, Malaysia.
Kamalnizat IbrahimDepartment of Orthopaedic, KPJ Ampang Puteri Specialist Hospital, Selangor, Malaysia.
Jagdeep Singh NanraPrince Court Medical Centre, Kuala Lumpur, Malaysia.
Muhindra GsangayaDepartment of Orthopaedics and Traumatology, Hospital Serdang, Selangor, Malaysia.
Hezery HarunDepartment of Orthopaedics and Traumatology, Hospital Pengajar Universiti Putra Malaysia, Selangor, Malaysia.
Khairrudin KandarDepartment of Orthopaedic, Avisena Specialist Hospital, Selangor, Malaysia.
Maatharasi BalanDepartment of Orthopaedics and Traumatology, Hospital Serdang, Selangor, Malaysia.
Shawn PehDepartment of Orthopaedics and Traumatology, Faculty of Medicine, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia.
Yogesh PokharkarSingapore Clinical Research Institute, Singapore, Singapore.
Abhinay IngoleSingapore Clinical Research Institute, Singapore, Singapore.
Mohammad Hisam AriffinDepartment of Orthopaedics and Traumatology, Faculty of Medicine, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia.
University Kebangsaan Malaysia Medical Centre · MYKPJ Ampang Puteri Specialist Hospital · MYSerdang Hospital · MYSingapore Clinical Research Institute · SGUniversiti Putra Malaysia · MY

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveMLC601/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.

methodsPatients 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).

resultsAmong 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.

conclusionMLC601/MLC901 is safe and may have a role in the treatment of patients with SCI. A controlled trial is justified.

Indexed as

Drugs, Chinese HerbalSpinal Cord InjuriesAdultCohort StudiesHumansMaleMiddle AgedRecovery of FunctionTreatment OutcomeYoung AdultDrugs, Chinese HerbalNeuroaidAmerican Spinal Injury Association Impairment ScaleMLC601MLC901RecoverySATURN studySpinal cord injury

Identifiers

PMID35604343
PMCPMC10274548
OpenAlexW4281400895

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.