Abstract:
STUDY DESIGN:Randomized 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 randomly assigned in a 2:1 ratio to the treatment (autologous incubated macrophages) or control (standard 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 study results do not support treatment of acute complete SCI with autologous incubated macrophage therapy as specified in this protocol.
journal_name
Spinal Cordjournal_title
Spinal cordauthors
Lammertse DP,Jones LA,Charlifue SB,Kirshblum SC,Apple DF,Ragnarsson KT,Falci SP,Heary RF,Choudhri TF,Jenkins AL,Betz RR,Poonian D,Cuthbert JP,Jha A,Snyder DA,Knoller Ndoi
10.1038/sc.2012.39subject
Has Abstractpub_date
2012-09-01 00:00:00pages
661-71issue
9eissn
1362-4393issn
1476-5624pii
sc201239journal_volume
50pub_type
杂志文章,多中心研究,随机对照试验相关文献
SPINAL CORD文献大全abstract:STUDY DESIGN:Cross-sectional study. OBJECTIVE:To compare exercise-related self-perceptions in persons with complete and incomplete spinal cord injury (SCI) and to identify factors that explain the variance of perceived exercise mastery in the study population. SETTING:Sunnaas Rehabilitation Hospital and the Norwegian...
journal_title:Spinal cord
pub_type: 杂志文章
doi:10.1038/sc.2009.136
更新日期:2010-05-01 00:00:00
abstract:STUDY DESIGN:A field study was conducted in 40 patients with multiple sclerosis (MS) by comparing their residual urine volumes with the Kurtzke Functional Systems Scales for pyramidal (PFS) or bladder functions (BFS). OBJECTIVES:To determine whether raised residual urine volumes necessitating intermittent self cathete...
journal_title:Spinal cord
pub_type: 杂志文章
doi:10.1038/sj.sc.3101022
更新日期:2000-07-01 00:00:00
abstract:STUDY DESIGN:Longitudinal panel design over 10 years. OBJECTIVES:To describe the health outcomes for people with spinal cord injury and identify how indicators of health change over time. SETTING:Queensland, Australia. METHODS:A structured interview consisting of measures of perceived health, medical service utiliza...
journal_title:Spinal cord
pub_type: 杂志文章
doi:10.1038/sj.sc.3102159
更新日期:2008-05-01 00:00:00
abstract:STUDY DESIGN:Intra- and inter-rater reliability study. OBJECTIVES:To assess intra- and inter-rater reliability of the Modified Ashworth Scale (MAS) and Spasm Frequency Score (SFS) in lower extremities in a population of spinal cord-injured persons, as well as correlations between the two scales. SETTING:Clinic for Sp...
journal_title:Spinal cord
pub_type: 杂志文章
doi:10.1038/sc.2015.230
更新日期:2016-09-01 00:00:00
abstract:STUDY DESIGN:Prospective multidimensional study by means of: (1) clinical assessment, (2) parental-administered questionnaire for general health (CHQ-PF50), and (3) standardised disability measurements. OBJECTIVES:To assess the health-related quality of life (QoL) and disability in children with spina bifida (SB) and ...
journal_title:Spinal cord
pub_type: 杂志文章
doi:10.1038/sj.sc.3101707
更新日期:2005-04-01 00:00:00
abstract:OBJECTIVE:To assess the effect from maximal bench press strength training (MST) on wheelchair propulsion work economy (WE). STUDY DESIGN:Pretest-posttest case-control group design. SETTING:St Olavs Hospital, Trondheim, Norway. METHODS:Seventeen male individuals with spinal cord injury (SCI) paraplegia were allocated...
journal_title:Spinal cord
pub_type: 杂志文章
doi:10.1038/sc.2016.27
更新日期:2016-10-01 00:00:00
abstract:OBJECTIVES:To evaluate the efficacy and safety over a 10-year period of any urological operations required by female patients with spinal cord lesions (SCLs). METHODS:Retrospective study of urological surgeries from our database performed on females with SCLs from 2001 to 2002. Surgery efficacy for neurogenic lower ur...
journal_title:Spinal cord
pub_type: 杂志文章
doi:10.1038/sc.2013.64
更新日期:2013-09-01 00:00:00
abstract:STUDY DESIGN:Retrospective. OBJECTIVES:To improve the use of bacteriological results for treating spinal cord-injured patients with infected pressure ulcers. SETTING:Microbiology and Orthopaedics Department, Ambroise Paré University Hospital, Boulogne-Billancourt, France. METHODS:Tissue specimens, sampled at the end...
journal_title:Spinal cord
pub_type: 杂志文章
doi:10.1038/sj.sc.3101568
更新日期:2004-04-01 00:00:00
abstract:STUDY DESIGN:A case report of Neisseria sicca/subflava discitis in a healthy elderly female. OBJECTIVE:To report a rare case, which is usually seen exclusively in children. SETTING:Stoke on Trent, England. METHOD:Case report, a 65-year-old female with a 6 month history of back and bilateral leg pain. X-rays showed c...
journal_title:Spinal cord
pub_type: 杂志文章
doi:10.1038/sj.sc.3101497
更新日期:2003-10-01 00:00:00
abstract:STUDY DESIGN:Single patient case report. OBJECTIVES:To present and discuss a case of spontaneous spinal subdural hematoma that was not associated with coagulation abnormality. SETTING:Seoul National University Hospital, Seoul, Korea. METHODS:Clinical and radiological magnetic resonance imaging follow-up of the patie...
journal_title:Spinal cord
pub_type: 杂志文章
doi:10.1038/sj.sc.3100967
更新日期:2000-03-01 00:00:00
abstract:STUDY DESIGN:Retrospective study. OBJECTIVES:The purpose of this investigation was to review the outcomes and safety of retrograde ureteroscopic laser lithotripsy (URS) for the treatment of urolithiasis in the spinal cord injury (SCI) population. SETTING:Virginia, USA. METHODS:All patients with SCI who underwent URS...
journal_title:Spinal cord
pub_type: 杂志文章
doi:10.1038/sc.2012.86
更新日期:2013-02-01 00:00:00
abstract:STUDY DESIGN:Case-control study. OBJECTIVES:The objective of this study was to provide some useful information concerning the incidence, clinical features, and risk factors for symptomatic postoperative spinal epidural hematoma (SPSEH) in an isolated cohort of patients undergoing spine tumor surgery. SETTING:Hospital...
journal_title:Spinal cord
pub_type: 杂志文章
doi:10.1038/s41393-019-0281-5
更新日期:2019-08-01 00:00:00
abstract:STUDY DESIGN:Retrospective case-control study. OBJECTIVES:The intent of this study was to investigate the relationships between vertebral degenerative changes resulting in spinal canal stenosis, spinal cord lesions and the development of spinal cord decompression sickness (DCS) in scuba divers. SETTING:Referral hyper...
journal_title:Spinal cord
pub_type: 杂志文章
doi:10.1038/sc.2013.121
更新日期:2014-03-01 00:00:00
abstract:STUDY DESIGN:Review. OBJECTIVES:To review literature on subjective well-being (SWB; mental health and life satisfaction) and on psychological and social support factors associated with these outcomes in people with spinal cord injury (SCI), in order to identify gaps in scientific knowledge and recommend research prior...
journal_title:Spinal cord
pub_type: 杂志文章,评审
doi:10.1038/sc.2011.182
更新日期:2012-05-01 00:00:00
abstract:STUDY DESIGN:Cross-sectional clinical study. OBJECTIVES:Plastic changes within cortical areas occur after traumatic spinal cord injury (TSCI). The aim of the study was to assess cortical activation in the chronic phase of TSCI using functional magnetic resonance imaging (fMRI). SETTING:Tartu University Hospital, Tart...
journal_title:Spinal cord
pub_type: 杂志文章
doi:10.1038/sc.2015.158
更新日期:2016-01-01 00:00:00
abstract:OBJECTIVE:To include a larger number of tetraplegics than in previous studies, in order to more reliably characterize the pathogenesis and predisposing factors of sleep apnea in tetraplegia. METHODS:Sleep breathing data and oxymetric values were investigated in 50 randomly selected tetraplegic patients and discussed i...
journal_title:Spinal cord
pub_type: 杂志文章
doi:10.1038/sj.sc.3101301
更新日期:2002-06-01 00:00:00
abstract:STUDY DESIGN:Face-to-face interview. OBJECTIVES:Pain interference is an important outcome measure in clinical pain trials. However, after spinal cord injury (SCI), interference caused by pain may be difficult to separate from interference caused by the physical impairment. The objective of this study was to determine ...
journal_title:Spinal cord
pub_type: 杂志文章
doi:10.1038/sc.2008.150
更新日期:2009-05-01 00:00:00
abstract:STUDY DESIGN:A cross-sectional survey. OBJECTIVES:To document bowel care practices of chronic spinal cord injury (SCI) patients in Pakistan. SETTINGS:Outpatient Department, Armed Forces Institute of Rehabilitation Medicine, Rawalpindi, Pakistan. METHODS:A total of 50 adult patients (18-65 years) with SCI of duration...
journal_title:Spinal cord
pub_type: 杂志文章
doi:10.1038/sc.2010.46
更新日期:2010-12-01 00:00:00
abstract::Chronic constipation is the main gastrointestinal complaint of spinal cord injury (SCI) patients, and has a significant effect on patients' lives, concerning nursing dependence, morbidity and complications. Many therapies have been proposed to treat chronic severe constipation, most of them with limited effect or bein...
journal_title:Spinal cord
pub_type: 临床试验,杂志文章
doi:10.1038/sj.sc.3100355
更新日期:1997-02-01 00:00:00
abstract::The case histories of two patients who had had a spinal cord injury (SCI) were selected by the senior author and sent to four experts in the field of SCI. Based on the 1992 American Spinal Injury Association (ASIA) and International Medical Society of Paraplegia (IMSOP) standards, the four participants plus the senior...
journal_title:Spinal cord
pub_type: 杂志文章
doi:10.1038/sj.sc.3100449
更新日期:1997-05-01 00:00:00
abstract:INTRODUCTION:Some studies have made use of the antioxidative capabilities of high doses of vitamins C and E with the aim of neutralizing the noxious effects of free radicals following spinal cord lesion. OBJECTIVES:To evaluate the effects of vitamins C and E, separately and together, on the functional performance of r...
journal_title:Spinal cord
pub_type: 杂志文章
doi:10.1038/sc.2008.155
更新日期:2009-06-01 00:00:00
abstract:STUDY DESIGN:Cross-sectional study. OBJECTIVES:There is a knowledge gap on urinary incontinence in women with spinal cord injury. Hence, the aim of this study was to determine the prevalence and conditions associated with urinary incontinence in this population. SETTING:Clinic for Spinal Cord Injuries, Rigshospitalet...
journal_title:Spinal cord
pub_type: 杂志文章
doi:10.1038/s41393-018-0157-0
更新日期:2018-12-01 00:00:00
abstract:STUDY DESIGN:A prospective, immunohistochemical study of bladder biopsies taken from spinal cord injury (SCI) patients. OBJECTIVES:To investigate whether cytokeratin 14 immunostaining may be useful to detect early squamous metaplasia in bladder biopsies from patients with SCI. SETTING:Southport, United Kingdom. METH...
journal_title:Spinal cord
pub_type: 杂志文章
doi:10.1038/sj.sc.3101464
更新日期:2003-08-01 00:00:00
abstract::Different conservative treatment modalities for the lower urinary tract dysfunction in patients with spinal cord lesion are reviewed. Conservative treatment is still the mainstay of the urological management in these patients. Growing experience has changed the classical approach. Spontaneous voiding with and without ...
journal_title:Spinal cord
pub_type: 杂志文章,评审
doi:10.1038/sj.sc.3101160
更新日期:2001-06-01 00:00:00
abstract:STUDY DESIGN:Retrospective chart audit. OBJECTIVES:This study investigated changes in sagittal alignment in adults after excision of thoracic spinal cord tumors without spinal fixation. SETTING:Single-center study at an academic orthopedic department in Japan. METHODS:We retrospectively reviewed records for 32 adult...
journal_title:Spinal cord
pub_type: 杂志文章
doi:10.1038/s41393-018-0235-3
更新日期:2019-05-01 00:00:00
abstract:STUDY DESIGN:A registry-based cross-sectional study. OBJECTIVES:To analyse the epidemiological and demographic characteristics of persons with traumatic spinal cord injury (TSCI) in Norway. SETTING:TSCI patients admitted for primary rehabilitation to one of the three specialised spinal cord injury (SCI) departments (...
journal_title:Spinal cord
pub_type: 杂志文章
doi:10.1038/s41393-018-0225-5
更新日期:2019-04-01 00:00:00
abstract::The aim of the multicentre study entitled 'Description and Documentation of Painful States in Spinal Cord Injury Patients', in addition to the description and documentation of chronic pain and stressful dysaesthesiae in SCI patients, was the search for correlations between these symptoms and medical and psychosocial v...
journal_title:Spinal cord
pub_type: 临床试验,杂志文章,多中心研究
doi:10.1038/sj.sc.3100411
更新日期:1997-07-01 00:00:00
abstract:STUDY DESIGN:Cross-sectional study. OBJECTIVES:To investigate the attentional requirements for maintaining standing balance in people with spinal cord injury (SCI) using a dual-task paradigm and to compare standing balance performance between SCI and able-bodied (AB) controls. SETTING:LaboratoryMethods:Nine adults wi...
journal_title:Spinal cord
pub_type: 杂志文章
doi:10.1038/sc.2017.42
更新日期:2017-10-01 00:00:00
abstract:STUDY DESIGN:Prospective cohort study. OBJECTIVES:To evaluate the relationship between quality of life (QOL) after a traumatic spinal cord injury (TSCI) and acute predictors, with a particular emphasis on the initial severity of the neurological injury. Secondarily, to compare the QOL after a TSCI with the general pop...
journal_title:Spinal cord
pub_type: 杂志文章
doi:10.1038/s41393-018-0178-8
更新日期:2018-11-01 00:00:00
abstract:STUDY DESIGN:Case-control study. OBJECTIVES:To investigate the level of autonomic nervous system dysfunction in patients with spinal cord injury and to determine its effect on the basal metabolic rate and oxygen consumption during daily living activities. SETTING:Turkish Armed Forces Rehabilitation Center, Ankara, Tu...
journal_title:Spinal cord
pub_type: 杂志文章
doi:10.1038/sc.2016.111
更新日期:2017-03-01 00:00:00