Multicenter Prospective Nonrandomized Controlled Clinical Trial to Prove Neurotherapeutic Effects of Granulocyte Colony-Stimulating Factor for Acute Spinal Cord Injury

Inada, Taigo; Takahashi, Hiroshi; Yamazaki, Masashi; Okawa, Akihiko; Sakuma, Takashi; Kato, Kei; Hashimoto, Mitsuhiro; Hayashi, Kôichi; Furuya, Takeo; Fujiyoshi, Takayuki; Kawabe, Junko; Mannoji, Chikato; Miyashita, Tetsuya; Kadota, Ryo; Someya, Yuichi; Ikeda, Osamu; Hashimoto, Masayuki; Suda, Kota; Kajino, Tomomichi; Ueda, Haruki; Ito, Yasuo; Ueta, Takayoshi; Hanaoka, Hideki; Takahashi, Kazuhisa; Koda, Masao

doi:10.1097/brs.0000000000000121

Cited by 46 publications

(40 citation statements)

References 36 publications

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“…Indeed, Japanese researchers recently applied G-CSF as a clinical treatment for patients suffering from SCI. Modest but non-negligible motor and sensory improvements were observed, whereas no adverse effects were reported [77–79], suggesting a potential beneficial effect of G-CSF in the therapy of SCI.…”

Section: Granulocyte Colony-stimulating Factor: Its Implication In Exmentioning

confidence: 99%

Neutrophil contribution to spinal cord injury and repair

Neirinckx

Coste

Franzen

et al. 2014

J Neuroinflammation

121

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Spinal cord injuries remain a critical issue in experimental and clinical research nowadays, and it is now well accepted that the immune response and subsequent inflammatory reactions are of significant importance in regulating the damage/repair balance after injury. The role of macrophages in such nervous system lesions now becomes clearer and their contribution in the wound healing process has been largely described in the last few years. Conversely, the contribution of neutrophils has traditionally been considered as detrimental and unfavorable to proper tissue regeneration, even if there are very few studies available on their precise impact in spinal cord lesions. Indeed, recent data show that neutrophils are required for promoting functional recovery after spinal cord trauma. In this review, we gathered recent evidence concerning the role of neutrophils in spinal cord injuries but also in some other neurological diseases, highlighting the need for further understanding the different mechanisms involved in spinal cord injury and repair.Electronic supplementary materialThe online version of this article (doi:10.1186/s12974-014-0150-2) contains supplementary material, which is available to authorized users.

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Section: Granulocyte Colony-stimulating Factor: Its Implication In Exmentioning

confidence: 99%

Neutrophil contribution to spinal cord injury and repair

Neirinckx

Coste

Franzen

et al. 2014

J Neuroinflammation

121

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“…Inada and colleagues in 2014 also compared patients with traumatic spinal cord injury admitted within 48 hours of injury treated by G-CSF and compared it with control group without medical neuroprotective treatment in non-randomized prospective trial and followed patients for one year later on, in seven days, three months, six months and one year after injury. It showed improvement in motor and grading ASIA score in G-CSF treated ones compared to control group at first week and a year later, though it lacked randomization and the G-CSF intervention was not compared to other modalities (26). In our study, the sampling was greater in number than that in all other similar articles, and it is the only prospective randomized clinical trial that compared G-CSF and high-dose methylprednisolone as neuroprotective therapy in patients with acute traumatic spinal cord injury.…”

Section: Resultsmentioning

confidence: 98%

A Comparison between Therapeutic Effect of Granulocyte Colony-stimulating Factor and Methylprednisolone in Treatment of Patients with Acute Traumatic Spinal Cord Injury

Yousefzadeh-Chabok

Alijani

Emamhadi

et al. 2016

IrJNS

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Background & Aim: Spinal cord injury (SCI) is one of the worst kinds of traumatic injuries with remarkable social and economic effects on communities. Methods & Materials/Patients: In this prospective randomized clinical trial, 122 patients with traumatic spinal cord injury were admitted to Poursina hospital within 48 hours of injury to compare granulocyte colony stimulating factor (G-CSF) and high-dose methylprednisolone as neuroprotective therapy. Results: In this research, 122 patients were studied out of whom 62 patients were included in the granulociote colony-stimulating factor (G-CSF) group with a mean age of 40.4, and 60 patients in the methylprednisolone group with an average age of 40.10 years. 55 out of 122 patients (45%) were completely paralyzed (Grade AIS:A) and 67 (55%) were with incomplete spinal injury (Grade AIS:B,C,D). The average American spinal injury association (ASIA) sensory scores in the two groups were similarly compared in the same four time intervals, and p values were 0.7, 0.3, 0.2, and 0.1. They were not statistically significant. Conclusion: According to the results, the G-CSF was shown to be beneficial in average ASIA motor and sensory scores in the two groups of male patients at six months of onset of G-CSF treatment (p value=0.04), and average ASIA motor scores improvement in the falls subgroup patients also differed significantly within six months of onset of G-CSF treatment (p value=0.03). A multicentre prospective randomized clinical trial to compare the placebo effect with G-CSF protocol's treatment, and also assessment of the cost benefits of the common medical treatment versus G-CSF are needed.

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“…Awareness of potential problems related to small sample size, yet without referring to the choice of a particular statistical method, was present in 92 studies (55%). Different implications thereof were mentioned, ranging from considerable baseline variability, which could not be accounted for, to limited generalizability of the results, decreased power, and the need for replication in larger samples . Seventeen studies (10%) stated a rule‐of‐thumb like justification for the choice of a particular statistical approach, mainly that nonparametric methods were used instead of parametric approaches due to the small sample size .…”

Section: Resultsmentioning

confidence: 99%

Sample sizes and statistical methods in interventional studies on individuals with spinal cord injury: A systematic review

Zimmermann

Bolter

Sluka

et al. 2019

J Evidence Based Medicine

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Aim Prevalence and incidence of spinal cord injury (SCI) are low. However, sample sizes have not been systematically examined yet, although this might represent useful information for study planning and power considerations. Therefore, our objective was to determine the median sample size in clinical trials on SCI individuals. Moreover, within small‐sample size studies, statistical methods and awareness of potential problems regarding small samples were examined. Methods We systematically reviewed all studies on human SCI individuals published between 2014 and 2015, where the effect of an intervention on one or more health‐related outcomes was assessed by means of a hypothesis test. If at least one group had a size <20, the study was classified as a small sample size study. PubMed was searched for eligible studies; subsequently, data on sample sizes and statistical methods were extracted and summarized descriptively. Results Out of 8897 studies 207 were included. Median total sample size was 18 (range 4‐582). Small sample sizes were found in 167/207 (81%) studies, resulting limitations and implications for statistical analyses were mentioned in 109/167 (65%) studies. Conclusions Although most recent SCI trials have been conducted with small samples, the consequences on statistical analysis methods and the validity of the results are rarely acknowledged.

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Multicenter Prospective Nonrandomized Controlled Clinical Trial to Prove Neurotherapeutic Effects of Granulocyte Colony-Stimulating Factor for Acute Spinal Cord Injury

Abstract: 3.

Cited by 46 publications

References 36 publications

Neutrophil contribution to spinal cord injury and repair

Neutrophil contribution to spinal cord injury and repair

A Comparison between Therapeutic Effect of Granulocyte Colony-stimulating Factor and Methylprednisolone in Treatment of Patients with Acute Traumatic Spinal Cord Injury

Sample sizes and statistical methods in interventional studies on individuals with spinal cord injury: A systematic review

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