[임상연구 동향] 척수 손상에 대한 줄기세포 치료 임상 연구
한국줄기세포학회
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척수 손상에 대한 줄기세포 치료 임상 연구
- Introduction
척수 손상 (Spinal cord injury)는 사고, 병 등으로 인하여 척수에 손상이 가, 운동, 감각 및 자율 신경에 일시적, 혹은 영구적 손상을 입는 것을 말한다. 척수 손상으로 인해 몸의 신경 제어에 이상이 생겨 내장 기능 및 운동 기능의 장애가 생길 수 있다. 척수 손상의 병리학적 기전은 1차 손상과 2차 손상으로 나눌 수 있다. 척수가 외부의 물리적인 힘에 의하여 손상되는 것을 1차 손상이라 한다. 1차 손상이 발생하면 조직 및 척수 신경세포의 괴사가 발생하는데, 이 때 동반되는 출혈, 활성 산소, 염증과 같은 반응에 의해 1차 손상 부위의 환경이 악화되어 추가적인 손상을 입는 것을 2차 손상이고 한다. 기존 척수 손상 치료법은 외과적인 방법을 사용하여 척추를 정렬 및 고정하여 추가적 손상을 막고, 적절한 약물을 통하여 2차 손상을 방지하며 재활 치료를 통해 기능 회복을 도모한다. 그러나 이러한 방법은 손상된 척수를 완전히 회복시킬 수 없어 그 효과가 제한된다.
최근 줄기세포 치료가 척수 손상에 대해 효과가 있음을 보여주는 연구가 보고되고 있다. 지금까지의 연구에 따르면 줄기세포는 손상된 뉴런을 대체하거나, 손상 부위의 환경을 개선하여 2차 손상을 억제하고 손상된 세포가 재생될 수 있는 환경을 만들어 준다. 특히 줄기세포의 분비 효과 (Paracrine effect)에 의한 미세환경의 조절이 주목받고 있는데, 줄기세포가 다양한 성장인자와 항염증 인자를 분비하여 주변 조직과 상호작용하며 이를 통하여 손상된 척수의 축삭 재생을 돕는다. 게다가 이식된 줄기세포의 종류에 따라서는 척수 세포로 분화하여 척수 손상으로 인한 기능저하를 복구할 수 있을 것으로 기대된다.
본 동향 연구에서는 척수 손상에 대한 줄기세포 치료 임상 연구를 알아보고자 한다. 척수 손상에 대한 줄기세포 임상 연구 동향에 대해 알아보기 위해 임상 시험 정보 사이트인 ClinicalTrials.gov를 사용하였으며, ‘Spinal cord injury AND stem cell’ 키워드로 검색하였다. 그리고 그 중에서 Completed / Recruiting / Active, not recruiting 상태의 임상연구만 다시 선택하였다. 그 결과 31개의 임상연구가 확인되었다.
대부분의 임상연구는 phase 1,2 상태였으며 한 연구만 phase 3 까지 진행되었다 (NCT01873547). 또한 이 중 3건의 연구 (NCT01909154, NCT02302157, NCT02481440)만 ClinicalTrials.gov에 그 결과가 게재되었다. 대부분의 연구들은 자가 지방/골수 유래 줄기세포 (Adipose / bone marrow-derived stem cell)를 사용하였으며, 그 다음으로는 탯줄 유래 줄기세포 (Umbilical cord / Wharton's jelly-derived stem cell)를 자주 사용하였다. 특히 탯줄 유래 줄기세포의 경우 이식 시 면역 거부 반응이 적다고 알려져 있으며, 자가 줄기세포의 문제점 (낮은 수급량, 채취 시 환자에게 고통 수반 등)를 해결할 수 있어 각광을 받고 있다. 특이 사항으로는 신경 줄기세포/전구세포를 이식한 연구가 3건 (NCT01321333, NCT01772810, NCT02302157) 확인되었다.
척수 손상은 아직까지 명확한 치료법이 없는 실정이다. 하지만 현재 연구되고 있는 줄기세포가 척수 손상에 대한 유망한 치료제로 부상하고 있으며, 줄기세포 연구가 보다 완성도를 높여갈수록 척수 손상이라는 난치병에 훌륭한 해결책을 제시할 것으로 기대된다.
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NCT Number Title Status Cell Sponsor/
CollaboratorsPhases Funded Bys Start Date Locations NCT00816803 Cell Transplant in Spinal Cord Injury Patients Completed Autologous bone marrow-derived Stem Cells Cairo University|Al-Azhar University|Medical Military Academy, Egypt|Alexandria University Phase 1|Phase 2 Other 2005-05-01 Egypt NCT01572376 Autologous Bone Marrow Stem Cells in Pressure Ulcer Treatment Completed Autologous bone marrow-derived Stem Cells Hospital Universitario Central de Asturias Phase 1|Phase 2 Other 2007-11-01 Spain NCT01186679 Safety and Efficacy of Autologous Bone Marrow Stem Cells in Treating Spinal Cord Injury Completed Autologous bone marrow-derived Stem Cells International Stemcell Services Limited Phase 1|Phase 2 Industry 2008-01-01 India NCT01274975 Autologous Adipose Derived MSCs Transplantation in Patient With Spinal Cord Injury. Completed Autologous adipose-derived Stem Cells R-Bio Phase 1 Industry 2009-07-01 Korea, Republic of NCT01325103 Autologous Bone Marrow Stem Cell Transplantation in Patients With Spinal Cord Injury Completed Autologous bone marrow-derived Stem Cells Hospital Sao Rafael|Oswaldo Cruz Foundation|Irep Sociedade de Ensino Superior M챕dio e Fundamental Limitada|Hospital Espanhol Not Applicable Other 2010-07-01 Brazil NCT01321333 Study of Human Central Nervous System Stem Cells (HuCNS-SC) in Patients With Thoracic Spinal Cord Injury Completed Human central nervous system-derived stem cells StemCells, Inc. Phase 1|Phase 2 Industry 2011-03-01 Canada/Switzerland NCT01624779 Intrathecal Transplantation Of Autologous Adipose Tissue Derived MSC in the Patients With Spinal Cord Injury Completed Autologous adipose-derived Stem Cells Bukwang Pharmaceutical Phase Industry 2012-04-01 Korea, Republic of NCT01873547 Different Efficacy Between Rehabilitation Therapy and Stem Cells Transplantation in Patients With SCI in China Completed Umbilical cord-derived stem cells General Hospital of Chinese Armed Police Forces Phase 3 Other 2012-06-01 China NCT01769872 Safety and Effect of Adipose Tissue Derived Mesenchymal Stem Cell Implantation in Patients With Spinal Cord Injury Completed Autologous adipose-derived Stem Cells R-Bio|Korea University Anam Hospital Phase 1|Phase 2 Industry|Other 2013-01-01 Korea, Republic of NCT01909154 Safety Study of Local Administration of Autologous Bone Marrow Stromal Cells in Chronic Paraplegia Completed Umbilical cord-derived stem cells Puerta de Hierro University Hospital Phase 1 Other 2013-03-01 Spain NCT04331405 Allogeneic Cord Blood Cells for Adults With Severe Acute Contusion Spinal Cord Injury Completed Umbilical cord blood mononuclear cells Sklifosovsky Institute of Emergency Care|National Medical Research Center for Cardiology, Ministry of Health of Russian Federation Phase 1|Phase 2 Other 2013-03-18 Russia NCT02482194 Autologous Mesenchymal Stem Cells Transplantation for Spinal Cord Injury- A Phase I Clinical Study Completed Bone marrow-derived stem Cells National Institute of Blood and Marrow Transplant (NIBMT), Pakistan|Armed Forces Institute of Regenerative Medicine Phase 1 Other|U.S. Fed 2013-06-01 Pakistan NCT01772810 Safety Study of Human Spinal Cord-derived Neural Stem Cell Transplantation for the Treatment of Chronic SCI Recruiting Spinal cord-derived neural stem cells Neuralstem Inc. Phase 1 Industry 2014-08-01 United States NCT02152657 Evaluation of Autologous Mesenchymal Stem Cell Transplantation in Chronic Spinal Cord Injury: a Pilot Study Completed Mesenchymal stem cells Hospital Sao Rafael Not Applicable Other 2015-01-01 Brazil NCT02302157 Dose Escalation Study of AST-OPC1 in Spinal Cord Injury Completed Oligodendrocyte progenitor cells Lineage Cell Therapeutics, Inc. Phase 1|Phase 2 Industry 2015-03-01 United States NCT02570932 Administration of Expanded Autologous Adult Bone Marrow Mesenchymal Cells in Established Chronic Spinal Cord Injuries Completed Autologous bone marrow-derived Stem Cells Puerta de Hierro University Hospital Phase 2 Other 2015-07-01 Spain NCT02687672 Transplantation of Autologous Bone Marrow or Leukapheresis-Derived Stem Cells for Treatment of Spinal Cord Injury Recruiting Bone marrow-derived stem cell / Leukapheresis-derived stem cell Stem Cells Arabia Phase 2 Other 2016-01-01 Jordan NCT02981576 Safety and Effectiveness of BM-MSC vs AT-MSC in the Treatment of SCI Patients. Completed Bone marrow-derived stem Cells / Adipose-derived stem cell University of Jordan Phase 1|Phase 2 Other 2016-11-01 Jordan NCT02917291 Safety and Preliminary Efficacy of FAB117-HC in Patients With Acute Traumatic Spinal Cord Injury Recruiting Allogeneic adipose-derived mesenchymal stem cells Ferrer Internacional S.A.|Histocell, S.L. Phase 1|Phase 2 Industry 2016-12-01 Spain NCT03003364 Intrathecal Administration of Expanded Wharton's Jelly Mesenchymal Stem Cells in Chronic Traumatic Spinal Cord Injury Completed Wharton's jelly-derived stem cells Banc de Sang i Teixits|Hospital de Neurorehabilitaci처 Institut Guttmann|Recerca Cl챠nica S.L.|Syntax for Science, S.L Phase 1|Phase 2 Other|Industry 2016-12-27 Spain NCT04288934 Treatment of Spinal Cord Injuries With (AutoBM-MSCs)vs (WJ-MSCs). Completed Autologous bone marrow-derived Stem Cells / Wharton's jelly-derived stem cell University of Jordan Phase 1 Other 2017-08-15 Jordan NCT03308565 Adipose Stem Cells for Traumatic Spinal Cord Injury Active, not recruiting Autologous adipose-derived Stem Cells Allan Dietz|Mayo Clinic Phase 1 Other 2017-12-05 United States NCT04213131 Efficacy and Safety of hUC-MSCs and hUCB-MSCs in the Treatment of Chronic Spinal Cord Injury Recruiting Umbilical cord-derived stem cells The First Affiliated Hospital of Dalian Medical University Not Applicable Other 2018-01-01 China NCT02481440 Repeated Subarachnoid Administrations of hUC-MSCs in Treating SCIv Completed Umbilical cord-derived stem cells Limin Rong|Third Affiliated Hospital, Sun Yat-Sen University Phase 1|Phase 2 Other 2018-03-30 China NCT03505034 Intrathecal Transplantation of UC-MSC in Patients With Late Stage of Chronic Spinal Cord Injury Recruiting Umbilical cord-derived stem cells Third Affiliated Hospital, Sun Yat-Sen University|West China Hospital|Shanghai East Hospital Phase 2 Other 2019-09-01 China NCT03521323 Intrathecal Transplantation of UC-MSC in Patients With Early Stage of Chronic Spinal Cord Injury Recruiting Umbilical cord-derived stem cells Third Affiliated Hospital, Sun Yat-Sen University|West China Hospital|Shanghai East Hospital Phase 2 Other 2019-09-01 China NCT03521336 Intrathecal Transplantation of UC-MSC in Patients With Sub-Acute Spinal Cord Injury Recruiting Umbilical cord-derived stem cells Third Affiliated Hospital, Sun Yat-Sen University|West China Hospital|Shanghai East Hospital Phase 2 Other 2019-09-01 China NCT04520373 Autologous Adipose Derived Mesenchymal Stem Cells for Spinal Cord Injury Patients Recruiting Autologous adipose-derived Stem Cells Mayo Clinic Phase 2 Other 2020-06-25 United States NCT04528550 Autologous Bone Marrow-derived Mononuclear Cells for Acute Spinal Cord Injury Recruiting Autologous bone marrow-derived Stem Cells Shanghai Changzheng Hospital Phase 2 Other 2020-10-01 China NCT04205019 Safety Stem Cells in Spinal Cord Injury Active, not recruiting Umbilical cord-derived stem cells Neuroplast Phase 1 Industry 2020-11-14 Spain NCT05018793 Safety of Cultured Autologous Adult Adipose Derived Mesenchymal Stem Cell Intrathecal Injection for SCI Recruiting Autologous adipose-derived Stem Cells The Foundation for Orthopaedics and Regenerative Medicine Phase 1 Other 2021-12-01 Greec