초록

운동기능 완전마비를 보이는 외상성 아급성 및 만성 경추 척수손상을 보이는 환자(1군; 19명, 2군; 14명)를 대상으로 인간 태아 뇌유래 신경줄기세포를 손상 부위에 이식하는 연구자 임상시험을 실시한 결과, 현재까지 줄기세포 이식술에 따른 특별한 부작용을 관찰할 수 없었고, 20-30%의 신경기능 개선 효과를 보여, 향후 척수손상에서 치료적 유용성을 강화한 신경줄기세포 이식술은 안전하고 유효한 신경재생 치료법으로 개발될 가능성을 확인함.

( 출처 : 요약서 )

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 (1st group), 17

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 (1st group), 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.
Of 14 treated subjects (2nd group), 13 were sensorimotor complete and 1 was motor complete and sensory incomplete.
Five patients were finished 1 year follow-up examination following cell transplantation and the others are progressing follow-up examinations. Until now, we could not observe any cell transplation-related side effects and some patients showed mild neurological improvements.

( 출처 : SUMMARY )

목차 Contents

• 표지 ... 1제출문 ... 2보고서 요약서 ... 3요약문 ... 4SUMMARY ... 56.1 총괄연구개발과제의 연구성과 실적 및 향후 계획 ... 66.2 연구성과 유형별 세부 내역 ... 77. 참여연구원 현황표 ... 9II. 총괄연구과제 연구결과 ... 10 1. 연구개발과제의 배경 및 필요성 ... 11 2. 국내외 기술개발 현황 ... 17 3. 연구개발과제의 추진체계 ... 18 4. 연구개발 수행내용 및 결과 ... 22 5. 목표달성도 및 관련분야 기여도 ... 44 6. 향후 연구성과 추진계획 ... 47 7. 연구개발결과의 파급효과 ... 49 8. 연구개발결과의 활용계획 ... 50 9. 연구개발과정에서 수집한 해외과학기술정보 ... 51 10. 기타 ... 51 11. 참고문헌 ... 51IV. 첨부서류 ... 54끝페이지 ... 71