Clinical Trial of Human Fetal Brain-Derived Neural Stem/Progenitor Cell Transplantation in Patients with Traumatic Cervical Spinal Cord Injury

• Published in: Journal of neural transplantation & plasticity Vol. 2015; no. 2015; pp. 1072 - 1093-093
• Main Authors: Lee, Il-Shin, Shin, Jeong Eun, Park, Kook In, Hwang, Kyujin, Jung, Kwangsoo, Lee, Hyejin, Yun, Seokhwan, Kim, Il-Sun, Yoo, Jeehyun, Kim, Keung Nyun, Shin, Ji Cheol, Kim, Miri
• Format: Journal Article
• Language: English
• Published: Cairo, Egypt Hindawi Limiteds 01.01.2015; Hindawi Publishing Corporation; John Wiley & Sons, Inc; Wiley
• Subjects: Adolescent; Adult; Cervical Cord - injuries; Clinical Study; Clinical trials; Electrodes; FDA approval; Female; Fetal Stem Cells - transplantation; Humans; Lower Extremity - innervation; Lower Extremity - physiopathology; Male; Middle Aged; Motor Activity; Muscle Spasticity; Neural Conduction; Neural Stem Cells - transplantation; Pain Measurement; Patients; Spinal cord injuries; Spinal Cord Injuries - pathology; Spinal Cord Injuries - rehabilitation; Spinal Cord Injuries - therapy; Stem Cell Transplantation - adverse effects; Stem cells; Studies; Transplantation; Transplants & implants; Treatment Outcome; Upper Extremity - innervation; Upper Extremity - physiopathology; Young Adult
• ISSN: 0792-8483; 2090-5904; 1687-5443; 1687-5443
• DOI: 10.1155/2015/630932

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.