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Granulocyte-colony-stimulating Factor for Acute Ischemic Stroke: A Randomized Controlled Trial (STEMTHER)

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Abstract

Granulocyte-colony-stimulating factor (G-CSF) functions both as a neuroprotectant and a stimulator of autologous bone marrow stem cell release. Therefore, administration of G-CSF should improve the outcome of stroke. Here, we examine the safety of using G-CSF to treat acute ischemic stroke using a randomized controlled trial involving 20 adult patients presenting with ischemia in the carotid region within 48 h of onset. The experimental group (n = 10) received subcutaneous G-CSF injections (10 mg kg−1 day−1) in addition to conventional therapy for 5 days. The primary outcome was motor function as measured by the modified Rankin Scale 180 days post-stroke. Safety was evaluated according to the frequency of hemorrhagic transformation of infarctions and serious adverse events. Only six patients in the experimental group completed full course of treatment, while four patients (three in the control and one in the experimental group) were lost to follow-up. We found the experimental and control groups did not differ significantly in either neurological impairment or degree of disability/dependence at 180 days post-stroke. We conclude that while adding G-CSF (10 mg kg−1 day−1) to acute ischemic stroke therapy for 5 days is safe, its efficacy remains unproven.

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Acknowledgments

The authors gratefully acknowledge Semen Spektor, MD, Ph.D.; Sergey Leontiev, MD, Ph.D.; Larisa Fechina, MD, Ph.D.; Mihail Nalesnik, MD, Ph.D.; Zoya Chechik, MD, Ph.D.; and Sergey Iniushkin, MD, Ph.D. for their assistance in organizing the study and Dmitry Rogov, MD; Evgeniy Rudnik, MD; Natalya Nikonova, MD; Olga Biserova, Nina Tregub, Vladimir Sukhanov, MD, Ph.D.; Leonid Saveliev, MD, Ph.D.; Tatyana Verzhbitskaya, MD, Ph.D.; and Alexander Popov, MD for their assistance in examination of patients. Polina Chernyh for her assistance in data preparation is also acknowledged.

Funding

The study was funded by the Institute of Medical Cell Technologies. The manufacturer of the drug (Biocad, Russia) supported the study only at the stage of preparing the protocol and obtaining permission to carry out the study. Roman Ivanov is a full-time employee of Biocad; he did not participate in treatment allocation, patient evaluation or analysis of the study results.

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Authors and Affiliations

  1. Clinical Institute of the Brain, Ural Department, Russian Academy of Medical Sciences, Yasnaya str. 38, 620102, Yekaterinburg, Russia

    Andrey Marisovich Alasheev, Andrey Avgustovich Belkin & Ilya Naumovich Leiderman

  2. The Institute of Medical Cell Technologies, Yekaterinburg, Russia

    Andrey Marisovich Alasheev, Andrey Avgustovich Belkin, Ilya Naumovich Leiderman & Roman Alekseyevich Ivanov

  3. The Sverdlovsk Regional Stroke Centre, Yekaterinburg, Russia

    Andrey Marisovich Alasheev, Andrey Avgustovich Belkin, Ilya Naumovich Leiderman & Tatyana Mikhailovna Isakova

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  1. Andrey Marisovich Alasheev
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  2. Andrey Avgustovich Belkin
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  3. Ilya Naumovich Leiderman
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  4. Roman Alekseyevich Ivanov
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  5. Tatyana Mikhailovna Isakova
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Correspondence to Andrey Avgustovich Belkin.

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Alasheev, A.M., Belkin, A.A., Leiderman, I.N. et al. Granulocyte-colony-stimulating Factor for Acute Ischemic Stroke: A Randomized Controlled Trial (STEMTHER). Transl. Stroke Res. 2, 358–365 (2011). https://doi.org/10.1007/s12975-011-0091-3

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  • DOI: https://doi.org/10.1007/s12975-011-0091-3

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