Complete spinal cord injury treatment using autologous bone marrow cell transplantation and bone marrow stimulation with granulocyte macrophage-colony stimulating factor: Phase I/II clinical trial.
To assess the safety and therapeutic efficacy of autologous human bone marrow cell (BMC) transplantation and the administration of granulocyte macrophage-colony stimulating factor (GM-CSF), a phase I/II open-label and nonrandomized study was conducted on 35 complete spinal cord injury patients. The BMCs were transplanted by injection into the surrounding area of the spinal cord injury site within 14 injury days (n = 17), between 14 days and 8 weeks (n = 6), and at more than 8 weeks (n = 12) after injury. In the control group, all patients (n = 13) were treated only with conventional decompression and fusion surgery without BMC transplantation. The patients underwent preoperative and follow-up neurological assessment using the American Spinal Injury Association Impairment Scale (AIS), electrophysiological monitoring, and magnetic resonance imaging (MRI). The mean follow-up period was 10.4 months after injury. At 4 months, the MRI analysis showed the enlargement of spinal cords and the small enhancement of the cell implantation sites, which were not any adverse lesions such as malignant transformation, hemorrhage, new cysts, or infections. Furthermore, the BMC transplantation and GM-CSF administration were not associated with any serious adverse clinical events increasing morbidities. The AIS grade increased in 30.4% of the acute and subacute treated patients (AIS A to B or C), whereas no significant improvement was observed in the chronic treatment group. Increasing neuropathic pain during the treatment and tumor formation at the site of transplantation are still remaining to be investigated. Long-term and large scale multicenter clinical study is required to determine its precise therapeutic effect. Disclosure of potential conflicts of interest is found at the end of this article.
Yoon
Seung Hwan
SH
Inha Neural Repair Center, Department of Neurosurgery, Inha University College of Medicine, 7-206, Sinheung-dong 3-ga, Jung-Gu, Incheon, Korea.
Shim
Yu Shik
YS
Park
Yong Hoon
YH
Chung
Jong Kwon
JK
Nam
Jung Hyun
JH
Kim
Myung Ok
MO
Park
Hyung Chun
HC
Park
So Ra
SR
Min
Byoung-Hyun
BH
Kim
Eun Young
EY
Choi
Byung Hyune
BH
Park
Hyeonseon
H
Ha
Yoon
Y
D000293:Adolescent; D000328:Adult; D000465:Algorithms; D001854:Bone Marrow Cells / Q000187:drug effects*; D016026:Bone Marrow Transplantation / Q000379:methods*; D002574:Cervical Vertebrae; D005260:Female; D005500:Follow-Up Studies; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007962:Leukocytes / Q000166:cytology / Q000187:drug effects; D007964:Leukocytosis / Q000097:blood / Q000209:etiology; D008297:Male; D008875:Middle Aged; D008954:Models, Biological; D010147:Pain Measurement; D011859:Radiography; D013119:Spinal Cord Injuries / Q000000981:diagnostic imaging / Q000628:therapy*; D019172:Transplantation Conditioning / Q000009:adverse effects / Q000379:methods*; D014182:Transplantation, Autologous
D016178:Granulocyte-Macrophage Colony-Stimulating Factor