title: Clinical Trial of Human Fetal Brain-Derived Neural Stem/Progenitor Cell Transplantation in Patients with Traumatic Cervical Spinal Cord Injury.
abstract: In a phase I/IIa open-label and nonrandomized controlled clinical trial, we sought to assess the safety and neurological effects of human neural stem/progenitor cells (hNSPCs) transplanted into the injured cord after traumatic cervical spinal cord injury (SCI). Of 19 treated subjects, 17 were sensorimotor complete and 2 were motor complete and sensory incomplete. hNSPCs derived from the fetal telencephalon were grown as neurospheres and transplanted into the cord. In the control group, who did not receive cell implantation but were otherwise closely matched with the transplantation group, 15 patients with traumatic cervical SCI were included. At 1 year after cell transplantation, there was no evidence of cord damage, syrinx or tumor formation, neurological deterioration, and exacerbating neuropathic pain or spasticity. The American Spinal Injury Association Impairment Scale (AIS) grade improved in 5 of 19 transplanted patients, 2 (A → C), 1 (A → B), and 2 (B → D), whereas only one patient in the control group showed improvement (A → B). Improvements included increased motor scores, recovery of motor levels, and responses to electrophysiological studies in the transplantation group. Therefore, the transplantation of hNSPCs into cervical SCI is safe and well-tolerated and is of modest neurological benefit up to 1 year after transplants. This trial is registered with Clinical Research Information Service (CRIS), Registration Number: KCT0000879.
authors.affiliation: Department of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul 120-752, Republic of Korea ; Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul 120-752, Republic of Korea.
authors.forename: Ji Cheol
authors.initials: JC
authors.lastname: Shin
authors.affiliation: Department of Neurosurgery, Yonsei University College of Medicine, Seoul 120-752, Republic of Korea.
authors.forename: Keung Nyun
authors.initials: KN
authors.lastname: Kim
authors.affiliation: Department of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul 120-752, Republic of Korea ; Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul 120-752, Republic of Korea.
authors.forename: Jeehyun
authors.initials: J
authors.lastname: Yoo
authors.affiliation: Department of Pediatrics, Severance Children's Hospital, Yonsei University College of Medicine, Seoul 120-752, Republic of Korea.
authors.forename: Il-Sun
authors.initials: IS
authors.lastname: Kim
authors.affiliation: BK21 Plus Project for Medical Science, Yonsei University College of Medicine, Seoul 120-752, Republic of Korea.
authors.forename: Seokhwan
authors.initials: S
authors.lastname: Yun
authors.affiliation: BK21 Plus Project for Medical Science, Yonsei University College of Medicine, Seoul 120-752, Republic of Korea.
authors.forename: Hyejin
authors.initials: H
authors.lastname: Lee
authors.affiliation: BK21 Plus Project for Medical Science, Yonsei University College of Medicine, Seoul 120-752, Republic of Korea.
authors.forename: Kwangsoo
authors.initials: K
authors.lastname: Jung
authors.affiliation: BK21 Plus Project for Medical Science, Yonsei University College of Medicine, Seoul 120-752, Republic of Korea.
authors.forename: Kyujin
authors.initials: K
authors.lastname: Hwang
authors.affiliation: BK21 Plus Project for Medical Science, Yonsei University College of Medicine, Seoul 120-752, Republic of Korea.
authors.forename: Miri
authors.initials: M
authors.lastname: Kim
authors.affiliation: Department of Pediatrics, Severance Children's Hospital, Yonsei University College of Medicine, Seoul 120-752, Republic of Korea.
authors.forename: Il-Shin
authors.initials: IS
authors.lastname: Lee
authors.affiliation: Department of Pediatrics, Severance Children's Hospital, Yonsei University College of Medicine, Seoul 120-752, Republic of Korea.
authors.forename: Jeong Eun
authors.initials: JE
authors.lastname: Shin
authors.affiliation: Department of Pediatrics, Severance Children's Hospital, Yonsei University College of Medicine, Seoul 120-752, Republic of Korea ; BK21 Plus Project for Medical Science, Yonsei University College of Medicine, Seoul 120-752, Republic of Korea.
authors.forename: Kook In
authors.initials: KI
authors.lastname: Park
mesh_terms: D000293:Adolescent; D000328:Adult; D066193:Cervical Cord / Q000293:injuries*; D005260:Female; D053686:Fetal Stem Cells / Q000637:transplantation*; D006801:Humans; D035002:Lower Extremity / Q000294:innervation / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D009043:Motor Activity; D009128:Muscle Spasticity; D009431:Neural Conduction; D058953:Neural Stem Cells / Q000637:transplantation*; D010147:Pain Measurement; D013119:Spinal Cord Injuries / Q000473:pathology / Q000534:rehabilitation* / Q000628:therapy*; D033581:Stem Cell Transplantation / Q000009:adverse effects*; D016896:Treatment Outcome; D034941:Upper Extremity / Q000294:innervation / Q000503:physiopathology; D055815:Young Adult