Literature DB >> 22391867

Neuroprotective therapy using granulocyte colony-stimulating factor for acute spinal cord injury: a phase I/IIa clinical trial.

Hiroshi Takahashi1, Masashi Yamazaki, Akihiko Okawa, Tsuyoshi Sakuma, Kei Kato, Mitsuhiro Hashimoto, Koichi Hayashi, Takeo Furuya, Takayuki Fujiyoshi, Junko Kawabe, Tomonori Yamauchi, Chikato Mannoji, Tomohiro Miyashita, Ryo Kadota, Masayuki Hashimoto, Yasuo Ito, Kazuhisa Takahashi, Masao Koda.   

Abstract

OBJECTIVE: Granulocyte colony-stimulating factor (G-CSF) is a cytokine that is clinically used to treat neutropenia. G-CSF also has non-hematopoietic functions and could potentially be used to treat neuronal injury. To confirm the safety and feasibility of G-CSF administration for acute spinal cord injury (SCI), we have initiated a phase I/IIa clinical trial of neuroprotective therapy using G-CSF.
METHODS: The trial included a total of 16 SCI patients within 48 h of onset. In the first step, G-CSF (5 μg/kg/day) was intravenously administered for 5 consecutive days to 5 patients. In the second step, G-CSF (10 μg/kg/day) was similarly administered to 11 patients. We evaluated motor and sensory functions of patients using the American Spinal Cord Injury Association (ASIA) score and ASIA impairment scale (AIS) grade.
RESULTS: In all 16 patients, neurological improvement was obtained after G-CSF administration. AIS grade increased by one step in 9 of 16 patients. A significant increase in ASIA motor scores was detected 1 day after injection (P < 0.01), and both light touch and pin prick scores improved 2 days after injection (P < 0.05) in the 10 μg group. No severe adverse effects were observed after G-CSF injection.
CONCLUSION: These results indicate that intravenous administration of G-CSF (10 μg/kg/day) for 5 days is essentially safe, and suggest that some neurological recovery may occur in most patients. We suggest that G-CSF administration could be therapeutic for patients with acute SCI.

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Year:  2012        PMID: 22391867      PMCID: PMC3508205          DOI: 10.1007/s00586-012-2213-3

Source DB:  PubMed          Journal:  Eur Spine J        ISSN: 0940-6719            Impact factor:   3.134


  35 in total

1.  Neuroprotective therapy using granulocyte colony-stimulating factor for patients with worsening symptoms of compression myelopathy, Part 1: a phase I and IIa clinical trial.

Authors:  Tsuyoshi Sakuma; Masashi Yamazaki; Akihiko Okawa; Hiroshi Takahashi; Kei Kato; Mitsuhiro Hashimoto; Koichi Hayashi; Takeo Furuya; Takayuki Fujiyoshi; Junko Kawabe; Chikato Mannoji; Ryo Kadota; Masayuki Hashimoto; Kazuhisa Takahashi; Masao Koda
Journal:  Eur Spine J       Date:  2011-09-21       Impact factor: 3.134

2.  Clinical toxicity and laboratory effects of granulocyte-colony-stimulating factor (filgrastim) mobilization and blood stem cell apheresis from normal donors, and analysis of charges for the procedures.

Authors:  P Anderlini; D Przepiorka; D Seong; P Miller; J Sundberg; B Lichtiger; F Norfleet; K W Chan; R Champlin; M Körbling
Journal:  Transfusion       Date:  1996-07       Impact factor: 3.157

3.  Neuroprotective effect of granulocyte colony-stimulating factor after focal cerebral ischemia.

Authors:  W-R Schäbitz; R Kollmar; M Schwaninger; E Juettler; J Bardutzky; M N Schölzke; C Sommer; S Schwab
Journal:  Stroke       Date:  2003-02-13       Impact factor: 7.914

4.  Peripheral blood stem cell mobilization and apheresis: analysis of adverse events in 94 normal donors.

Authors:  M Murata; M Harada; S Kato; S Takahashi; H Ogawa; S Okamoto; S Tsuchiya; H Sakamaki; Y Akiyama; Y Kodera
Journal:  Bone Marrow Transplant       Date:  1999-11       Impact factor: 5.483

5.  Early complications of high-dose methylprednisolone sodium succinate treatment in the follow-up of acute cervical spinal cord injury.

Authors:  T Matsumoto; T Tamaki; M Kawakami; M Yoshida; M Ando; H Yamada
Journal:  Spine (Phila Pa 1976)       Date:  2001-02-15       Impact factor: 3.468

6.  CNS-targeted viral delivery of G-CSF in an animal model for ALS: improved efficacy and preservation of the neuromuscular unit.

Authors:  Alexandre Henriques; Claudia Pitzer; Tanjew Dittgen; Matthias Klugmann; Luc Dupuis; Armin Schneider
Journal:  Mol Ther       Date:  2010-12-07       Impact factor: 11.454

7.  A randomized, controlled trial of methylprednisolone or naloxone in the treatment of acute spinal-cord injury. Results of the Second National Acute Spinal Cord Injury Study.

Authors:  M B Bracken; M J Shepard; W F Collins; T R Holford; W Young; D S Baskin; H M Eisenberg; E Flamm; L Leo-Summers; J Maroon
Journal:  N Engl J Med       Date:  1990-05-17       Impact factor: 91.245

8.  Recombinant human granulocyte-colony stimulating factor administration for treating amyotrophic lateral sclerosis: A pilot study.

Authors:  Beatrice Nefussy; Irena Artamonov; Varda Deutsch; Ela Naparstek; Arnon Nagler; Vivian E Drory
Journal:  Amyotroph Lateral Scler       Date:  2010

9.  Purification of a factor inducing differentiation in murine myelomonocytic leukemia cells. Identification as granulocyte colony-stimulating factor.

Authors:  N A Nicola; D Metcalf; M Matsumoto; G R Johnson
Journal:  J Biol Chem       Date:  1983-07-25       Impact factor: 5.157

10.  Granulocyte colony-stimulating factor for acute ischemic stroke: a randomized controlled trial.

Authors:  Woei-Cherng Shyu; Shinn-Zong Lin; Chau-Chin Lee; Demeral David Liu; Hung Li
Journal:  CMAJ       Date:  2006-03-03       Impact factor: 8.262

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  21 in total

Review 1.  Regenerative Therapies for Spinal Cord Injury.

Authors:  Nureddin Ashammakhi; Han-Jun Kim; Arshia Ehsanipour; Rebecca D Bierman; Outi Kaarela; Chengbin Xue; Ali Khademhosseini; Stephanie K Seidlits
Journal:  Tissue Eng Part B Rev       Date:  2019-10-23       Impact factor: 6.389

Review 2.  Clinical Trials in Traumatic Spinal Cord Injury.

Authors:  Jayne Donovan; Steven Kirshblum
Journal:  Neurotherapeutics       Date:  2018-07       Impact factor: 7.620

3.  Neuroprotective Effects of Direct Intrathecal Administration of Granulocyte Colony-Stimulating Factor in Rats with Spinal Cord Injury.

Authors:  Wu-Fu Chen; Chun-Hong Chen; Nan-Fu Chen; Chun-Sung Sung; Zhi-Hong Wen
Journal:  CNS Neurosci Ther       Date:  2015-07-20       Impact factor: 5.243

4.  Neuroprotective therapy with granulocyte colony-stimulating factor in acute spinal cord injury: a comparison with high-dose methylprednisolone as a historical control.

Authors:  Koshiro Kamiya; Masao Koda; Takeo Furuya; Kei Kato; Hiroshi Takahashi; Tsuyoshi Sakuma; Taigo Inada; Mitsutoshi Ota; Satoshi Maki; Akihiko Okawa; Yasuo Ito; Kazuhisa Takahashi; Masashi Yamazaki
Journal:  Eur Spine J       Date:  2014-06-25       Impact factor: 3.134

Review 5.  Concise Review: Bridging the Gap: Novel Neuroregenerative and Neuroprotective Strategies in Spinal Cord Injury.

Authors:  Christopher S Ahuja; Michael Fehlings
Journal:  Stem Cells Transl Med       Date:  2016-04-29       Impact factor: 6.940

Review 6.  Granulocyte Colony-Stimulating Factor (G-CSF) for the Treatment of Spinal Cord Injury.

Authors:  MirHojjat Khorasanizadeh; Mahsa Eskian; Alexander R Vaccaro; Vafa Rahimi-Movaghar
Journal:  CNS Drugs       Date:  2017-11       Impact factor: 5.749

Review 7.  A Systematic Review of Experimental Strategies Aimed at Improving Motor Function after Acute and Chronic Spinal Cord Injury.

Authors:  Joyce Gomes-Osman; Mar Cortes; James Guest; Alvaro Pascual-Leone
Journal:  J Neurotrauma       Date:  2016-01-20       Impact factor: 5.269

Review 8.  Assessment and management of acute spinal cord injury: From point of injury to rehabilitation.

Authors:  Laureen D Hachem; Christopher S Ahuja; Michael G Fehlings
Journal:  J Spinal Cord Med       Date:  2017-06-01       Impact factor: 1.985

Review 9.  The Granulocyte-colony stimulating factor has a dual role in neuronal and vascular plasticity.

Authors:  Stephanie Wallner; Sebastian Peters; Claudia Pitzer; Herbert Resch; Ulrich Bogdahn; Armin Schneider
Journal:  Front Cell Dev Biol       Date:  2015-08-07

10.  Case Report: Combination Therapy with Mesenchymal Stem Cells and Granulocyte-Colony Stimulating Factor in a Case of Spinal Cord Injury.

Authors:  Nazi Derakhshanrad; Hooshang Saberi; Keyvan Tayebi Meybodi; Mohammad Taghvaei; Babak Arjmand; Hamid Reza Aghayan; Amir Hassan Kohan; Mohammad Haghpanahi; Shahrokh Rahmani
Journal:  Basic Clin Neurosci       Date:  2015-10
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