***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Background : Steroid hormones offer promising therapeutic perspectives during the acute phase of spinal cord injury ( SCI ) while the role of progesterone and vitamin D remain controversial . The aim of the current study was to investigate the effects of progesterone and vitamin D on functional outcome of patients with acute traumatic SCI . Methods : This was a r and omized clinical trial including 64 adult patients with acute traumatic SCI admitted within 8 hours of injury . All the patients received methylprednisolone on admission according to st and ard protocol ( 30 mg/kg as bolus dose and 15 mg/kg each 3 hours up to 24 hours ) . Patients were r and omly assigned to receive intramuscular injection of 0.5 mg/kg progesterone twice daily and 5µg/kg oral vitamin D3 twice daily up to 5 days ( n = 32 ) or placebo ( n = 32 ) . Patients were visited 6 days , 3 and 6 months after injury and motor and sensory function was assessed according to American Spinal Injury Association ( ASIA ) score . Results : There was no significant difference between two study groups regarding age ( P = 0.341 ) , sex ( P = 0.802 ) and therapy lag ( P = 0.609 ) . The motor powers and sensory function increased significantly after 6 months in both study groups . Those who received progesterone and vitamin D had significantly higher motor powers and sensory function after 6 months of therapy . Those who received the therapy within 4 hours of injury , had significantly higher motor powers and sensory function 6 months after treatment in progesterone and vitamin D group . Therapy lag was negatively associated with 6-month motor powers and sensory function  in progesterone and vitamin D group . Conclusions : Administration of progesterone and vitamin D in acute phase of traumatic SCI is associated with better functional recovery and outcome Abstract Traumatic spinal cord injury ( SCI ) is associated with a lifetime of disability stemming from loss of motor , sensory , and autonomic functions ; these losses , along with increased comorbid sequelae , negatively impact health outcomes and quality of life . Early decompression surgery post-SCI can enhance patient outcomes , but does not directly facilitate neural repair and regeneration . Currently , there are no U.S. Food and Drug Administration – approved pharmacological therapies to augment motor function and functional recovery in individuals with traumatic SCI . After an SCI , the enzyme , Rho , is activated by growth-inhibitory factors and regulates events that culminate in collapse of the neuronal growth cone , failure of axonal regeneration , and , ultimately , failure of motor and functional recovery . Inhibition of Rho activation is a potential treatment for injuries such as traumatic SCI . VX-210 , an investigational agent , inhibits Rho . When administered extradurally after decompression ( corpectomy or laminectomy ) and stabilization surgery in a phase 1/2a study , VX-210 was well tolerated . Here , we describe the design of the SPRING trial , a multicenter , phase 2b/3 , r and omized , double-blind , placebo-controlled clinical trial to evaluate the efficacy and safety of VX-210 ( NCT02669849 ) . A subset of patients with acute traumatic cervical SCI is currently being enrolled in the United States and Canada .  Medical , neurological , and functional changes are evaluated at 6 weeks and at 3 , 6 , and 12 months after VX-210 administration . Efficacy will be assessed by the primary outcome measure , change in upper extremity motor score at 6 months post-treatment , and by secondary outcomes that include question -based and task-based evaluations of functional recovery Multiple lines of evidence have vali date d the Rho pathway as important in controlling the neuronal response to growth inhibitory proteins after central nervous system ( CNS ) injury . A drug called BA-210 ( trademarked as Cethrin ( ® ) ) blocks activation of Rho and has shown promise in pre- clinical animal studies in being used to treat spinal cord injury ( SCI ) . This is a report of a Phase I/IIa clinical study design ed to test the safety and tolerability of the drug , and the neurological status of patients following the administration of a single dose of BA-210 applied during surgery following acute SCI . Patients with thoracic ( T2-T12 ) or cervical ( C4-T1 ) SCI were sequentially recruited for this dose-ranging ( 0.3 mg to 9 mg Cethrin ) , multi-center study of 48 patients with complete American Spinal Injury Association assessment ( ASIA ) A. Vital signs ; clinical laboratory tests ; computed tomography ( CT ) scans of the spine , head , and abdomen ; magnetic resonance imaging ( MRI ) of the spine , and ASIA assessment were performed in the pre- study period and in follow-up periods out to 1 year after treatment . The treatment-emergent adverse events that were reported were typical for a population of acute SCI patients , and no serious adverse events were attributed to the drug . The pharmacokinetic analysis showed low levels of systemic exposure to the drug , and there was high inter-patient variability . Changes in ASIA motor scores from baseline were low across all dose groups in thoracic patients ( 1.8±5.1 ) and larger in cervical patients ( 18.6±19.3 ) . The largest change in motor score was observed in the cervical patients treated with 3 mg of Cethrin in whom a 27.3±13.3 point improvement in ASIA motor score at 12 months was observed . Approximately 6 % of thoracic patients converted from ASIA A to ASIA C or D compared to 31 % of cervical patients and 66 % for the 3-mg cervical cohort . Although the patient numbers are small , the observed motor recovery in this open-label trial suggests that BA-210 may increase neurological recovery after complete SCI . Further clinical trials with Cethrin in SCI patients are planned , to establish evidence of efficacy Study design : Phase- I/II , prospect i ve , r and omized , single-blind , controlled pilot study . Primary Objective : To determine the safety and feasibility of autologous bone marrow transplantation in patients with acute spinal cord injury ( SCI ) via two routes of transplantation as compared with controls . Setting : Indian Spinal Injuries Center , New Delhi . Methods : Twenty-one subjects with acute , American Spinal Injury Association Impairment Scale ( AIS ) A ( complete ) , traumatic SCI with neurological level T1–T12 , were recruited and r and omized into three groups of seven subjects each . Two groups underwent cell transplantation through the intrathecal or intralesional route , whereas the third served as control . Participants were assessed at baseline and followed up at 6 months and 12-months post enrollment . Safety and tolerability were evaluated by monitoring for any adverse events . Efficacy was assessed through neurological , functional and psychological evaluation , as well as through electrophysiological studies and urodynamics . Results : Surgery was tolerated well by all participants . There were no significant adverse events attributable to the procedure . There was no significant improvement in the neurological , electrophysiological or urodynamic efficacy variables . A statistically significant improvement in functional scores as evaluated by the Spinal Cord Independence Measure and International Spinal Cord Injury Scale was observed in all groups . Conclusions : The procedure is safe and feasible in AIS A participants with thoracic-level injuries at 12-months follow-up . No efficacy could be demonstrated that could be attributed to the procedure Background : Riluzole is a sodium channel-blocking agent used in treating amyotrophic lateral sclerosis . It has been approved by the U.S. Food and Drug Administration , Canadian and Australian authorities , and in many other countries . A phase I trial of riluzole for acute spinal cord injury ( SCI ) provided safety and pharmacokinetic data and suggested neuroprotective benefits . A phase IIB/III double-blinded r and omized controlled trial ( RCT ) started in January 2014 ( https:// clinical trials.gov , NCT01597518 ) . This article describes the pathophysiological rationale , pre clinical experience and design of the phase IIB/III RCT of Riluzole in Acute Spinal Cord Injury Study ( RISCIS ) . Objectives : The primary objective of the trial is to evaluate the superiority of riluzole , at a dose of 100 mg BID in the first 24 h followed by 50 mg BID for the following 13 days post injury , compared with placebo in improving neurological motor outcomes in patients with C4–C8 level , International St and ards for Neurological Classification of Spinal Cord Injury Examination ( ISNCSCI ) grade A , B or C acute ( within 12 h post injury ) SCI . Setting : Acute trauma centers worldwide Methods : A double-blind , multi-center , placebo-controlled RCT will enroll 351 participants r and omized 1:1 to riluzole and placebo .  The primary end point is the change between 180 days and baseline in ISNCSCI Motor Score . This study has 90 % power to detect a change of nine points in ISNCSCI Motor Score at one-sided α=0.025 . Results : Currently enrolling in 11 centers . Conclusion : This study will provide class I evidence regarding the safety and neuroprotective efficacy of riluzole in patients with acute cervical SCI Study design : Prospect i ve multicenter longitudinal cohort study . Objective : To vali date the prognostic value of the acute phase sacral sparing measurements with regard to chronic phase-independent ambulation in patients with traumatic spinal cord injury ( SCI ) . Setting : European Multicenter Study of Human Spinal Cord Injury ( EM-SCI ) . Methods : In 432 patients , acute phase ( 0–15 days ) American Spinal Injury Association (ASIA)/International Spinal Cord Society neurological st and ard scale ( AIS ) grade s , ASIA sacral sparing measurements , which are S4–5 light touch ( LT ) , S4–5 pin prick ( PP ) , anal sensation and voluntary anal contraction ; and chronic phase ( 6 or 12 months ) indoor mobility Spinal Cord Independence Measure ( SCIM ) measurements were analyzed . Calculations of positive and negative predictive values ( PPV/NPV ) as well as univariate and multivariate logistic regressions were performed in all four sacral sparing criteria . The area under the receiver-operating characteristic curve ( AUC ) ratios of all regression equations was calculated . Results : To achieve independent ambulation 1-year post injury , a normal S4–5 PP score showed the best PPV ( 96.5 % , P<0.001 , 95 % confidence interval ( 95 % CI ) : 87.9–99.6 ) . Best NPV was reported in the S4–5 LT score ( 91.7 % , P<0.001 , 95 % CI : 81.6–97.2 ) . The use of the combination of only  voluntary anal contraction and the S4–5 LT and PP sensory scores ( AUC : 0.906 , P<0.001 , 95 % CI : 0.871–0.941 ) showed significantly better ( P<0.001 , 95 % CI : 0.038–0.128 ) discriminating results in prognosticating 1-year independent ambulation than with the use of currently used distinction between complete and incomplete SCI ( AUC : 0.823 , P<0.001 , 95 % CI : 0.781–0.864 ) . Conclusions : Out of the four sacral sparing criteria , the acute phase anal sensory score measurements do not contribute significantly to the prognosis of independent ambulation . The combination of the acute phase voluntary anal contraction and the S4–5 LT and PP scores , predicts significantly better chronic phase-independent ambulation outcomes than the currently used distinction between complete and incomplete SCI.Sponsorship : This study was granted by ‘ Acute Zorgregio Oost ’ and the ‘ Internationale Stiftung für Forschung in Paraplegie ( IFP ) ’ Study design : R and omized controlled trial with single-blinded primary outcome assessment . Objectives : To determine the efficacy and safety of autologous incubated macrophage treatment for improving neurological outcome in patients with acute , complete spinal cord injury ( SCI ) . Setting : Six SCI treatment centers in the United States and Israel . Methods : Participants with traumatic complete SCI between C5 motor and T11 neurological levels who could receive macrophage therapy within 14 days of injury were r and omly assigned in a 2:1 ratio to the treatment ( autologous incubated macrophages ) or control ( st and ard of care ) groups . Treatment group participants underwent macrophage injection into the caudal boundary of the SCI . The primary outcome measure was American Spinal Injury Association ( ASIA ) Impairment Scale ( AIS ) A – B or better at ⩾6 months . Safety was assessed by analysis of adverse events ( AEs ) . Results : Of 43 participants ( 26 treatment , 17 control ) having sufficient data for efficacy analysis , AIS A to B or better conversion was experienced by 7 treatment and 10 control participants ; AIS A to C conversion was experienced by 2 treatment and 2 control participants . The primary outcome analysis for subjects with at least 6 months follow-up showed a trend favoring the control group that did not achieve statistical significance ( P=0.053 ) . The mean number of AEs reported per participant was not significantly different between the groups ( P=0.942 ) . Conclusion : The analysis failed to show a significant difference in primary outcome between the two groups . The 
    Output:
    
Modest benefits were attributed to minocycline and Sygen ( without statistical significance ) , and some benefits were obtained with erythropoietin and progesterone plus vitamin D in neurological outcome .
For MP , the benefits are also controversial and may be attributed to statistical artifacts and with a high risk of adverse effects .
The other substances did not change the final outcome .
Conclusions : Our review reported some potential substances that may improve neurological outcome in acute SCI : MP , vitamin D associated with progesterone , and erythropoietin .