Multicenter prospective nonrandomized controlled clinical trial to prove neurotherapeutic effects of granulocyte colony-stimulating factor for acute spinal cord injury: analyses of follow-up cases after at least 1 year.

Abstract

STUDY DESIGN:

An open-labeled multicenter prospective nonrandomized controlled clinical trial.

OBJECTIVE:

To confirm the feasibility of using granulocyte colony-stimulating factor (G-CSF) for treatment of acute spinal cord injury (SCI).

SUMMARY OF BACKGROUND DATA:

We previously reported that G-CSF promotes functional recovery after compression-induced SCI in mice. On the basis of these findings, we conducted a multicenter prospective controlled clinical trial to assess the feasibility of G-CSF therapy for patients with acute SCI.

METHODS:

The trial ran from August 2009 to March 2011, and included 41 patients with SCI treated within 48 hours of onset. Informed consent was obtained from all patients. After providing consent, patients were divided into 2 groups. In the G-CSF group (17 patients), G-CSF (10 μg/kg/d) was intravenously administered for 5 consecutive days, and in the control group (24 patients), patients were similarly treated except for the G-CSF administration. We evaluated motor and sensory functions using the American Spinal Cord Injury Association score and American Spinal Cord Injury Association impairment scale at 1 week, 3 months, 6 months, and 1 year after onset.

RESULTS:

Only 2 patients did not experience American Spinal Cord Injury Association impairment scale improvement in the G-CSF group. In contrast, 15 patients in the control group did not experience American Spinal Cord Injury Association impairment scale improvement. In the analysis of increased American Spinal Cord Injury Association motor score, a significant increase in G-CSF group was detected from 1 week after the administration compared with the control group. After that, some spontaneous increase of motor score was detected in control group, but the significant increase in G-CSF group was maintained until 1 year of follow-up.

CONCLUSION:

Despite the limitation that patient selection was not randomized, the present results suggest the possibility that G-CSF administration has beneficial effects on neurological recovery in patients with acute SCI.

LEVEL OF EVIDENCE:

3.

• Authors: Taigo Inada, Hiroshi Takahashi, Masashi Yamazaki, Akihiko Okawa, Tsuyoshi Sakuma, Kei Kato, Mitsuhiro Hashimoto, Koichi Hayashi, Takeo Furuya, Takayuki Fujiyoshi, Junko Kawabe, Chikato Mannoji, Tomohiro Miyashita, Ryo Kadota, Yukio Someya, Osamu Ikeda, Masayuki Hashimoto, Kota Suda, Tomomichi Kajino, Haruki Ueda, Yasuo Ito, Takayoshi Ueta, Hideki Hanaoka, Kazuhisa Takahashi, Masao Koda
• Journal: Spine (Spine (Phila Pa 1976)) Vol. 39 Issue 3 Pg. 213-9 (Feb 01 2014) ISSN: 1528-1159 [Electronic] United States
• PMID: 24299727 (Publication Type: Controlled Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Granulocyte Colony-Stimulating Factor

Topics

• Acute Disease
• Adult
• Aged
• Aged, 80 and over
• Feasibility Studies
• Female
• Follow-Up Studies
• Granulocyte Colony-Stimulating Factor (administration & dosage)
• Humans
• Male
• Middle Aged
• Prospective Studies
• Recovery of Function (drug effects, physiology)
• Spinal Cord Injuries (diagnosis, drug therapy, physiopathology)
• Time Factors
• Treatment Outcome
• Young Adult