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1、脊髓損傷 臨床上的問題 Spinal Cord Injury The Clinical ProblemKeith DK Luk Chair Professor Huang, and replace death cells with OEC transplantation (Li, J of Neurosci. 1998; Huang, 2003) or Stem cells transplantation (Harper, PNAS 2004).2003) or Stem cells transplantation (Harper, PNAS 2004).2. 2. 軸軸突切断（突切断（Axo
2、tomyAxotomy）的治療的治療增强增强軸軸突切突切斷斷神神經經元的再生能力。元的再生能力。 Enhance regeneration ability of axotomized neurons (Pears Nature Enhance regeneration ability of axotomized neurons (Pears Nature Medicine, 2004; Yick, J Neurotrauma, 2004).Medicine, 2004; Yick, J Neurotrauma, 2004).1a1b3 2123 4524,5,6脊髓损脊髓损傷傷的突破性研究的突
3、破性研究( (二二) ) （Breakthrough Studies on the Field of Spinal Cord InjuryBreakthrough Studies on the Field of Spinal Cord Injury） 3. 3. 去髓鞘（去髓鞘（DemyelinationDemyelination）的治療的治療通通過過施施萬萬细胞移植重建髓鞘细胞移植重建髓鞘 。Rebuild myelination by Schwanns cell transplantation (Xu, Rebuild myelination by Schwanns cell transp
4、lantation (Xu, EJN 1999; Sivasankaran, Nature Neurosci. 2004).EJN 1999; Sivasankaran, Nature Neurosci. 2004).4,5,6. 4,5,6. 膠質膠質癍痕及抑制性分子（癍痕及抑制性分子（Glial scar and Inhibit moleculesGlial scar and Inhibit molecules）通通過過改改變變局部化局部化學環學環境减少癍痕形成，去除抑制因子。境减少癍痕形成，去除抑制因子。 Reduce glial scar and remove inhibitor mo
5、lecules by changing the local chemical Reduce glial scar and remove inhibitor molecules by changing the local chemical environment (Yick, Neuroreport, 2000; Moon, Nature Neurosci. 2001). environment (Yick, Neuroreport, 2000; Moon, Nature Neurosci. 2001). 用於治療用於治療脊髓脊髓損傷的幹細胞損傷的幹細胞Clinical Trials Centr
6、e Faculty of Medicine The University of Hong Kong8/F Clinical Pathology Building Queen Mary Hospital, Hong KongTel: (852) 2855 4664 Fax: (852) 2974 1248 E-mail: ctcentrehkucc.hku.hkwww.hku.hk/ctc香港大學醫學院 臨床試驗中心Symposium on Clinical Trial Central Laboratory Servicesdue to the lack of investigators and
7、 patients in the established regions.Study sitesDrug development has become a global activity 由於研究員及合適参與臨床試驗的病人在已發展 地區均出現短缺，臨床試驗正趨向全球化。試驗場地Symposium on Clinical Trial Central Laboratory Services19801990 1996 ICH GCP Guideline 良好臨床試驗管理規範Symposium on Clinical Trial Central Laboratory Services已發出之臨床試驗證
8、書Global clinical trials Into China and HK from other regions 吸引世界各地之科研機構 到中、港進行臨床試驗Our aim 我們的目標Products from China and HK 協助中、港之醫藥 產品進軍國際市場Our aim 我們的目標 Highly qualified clinical investigators 高質素之臨床研究員 Scientific expertise 科學專業知識 Experienced in clinical research 豐富之臨床研究經 驗 High population density
9、高人口密度 Excellent infrastructure 優良之基建 and more 及其他有利條件Why Hong Kong? Why Hong Kong? 為何選擇香港為何選擇香港? ?Clinical Sciences Number of Publications (1991-2002) 臨床科學 出版數目 (1991-2002)Clinical Trial / Research Experience 臨床試驗/研究經驗Hong Kong Hospital Authority ClustersHong Kong Hospital Authority ClustersHA7 Clus
10、ters 七個聯網 43 Hospitals/Institutions 四十三間醫院/機構 29,022 Beds 二萬九千零二十二個床位 6.8 Million Population 六百八十萬人口 香港醫院管理局聯網Hong Kong Hospital Authority ClustersHong Kong Hospital Authority Clusters Compliance with ICH GCP 符合良好臨床試驗管理規範之標準 Uniform operations 統一運作標準 HA Guidelines 醫院管理局指引 SOPs 標準運作程序 Trained EC memb
11、ers 曾受訓之倫理委員會會員Ethics Committees Ethics Committees 倫理委員會倫理委員會香港醫院管理局聯網Established in 1998 under the Faculty of Medicine of The University of Hong Kong (founded in 1887) 於一九九八年在香港大學醫學院之下成立The first full-service Academic Research Organization (ARO) in clinical trials in Asia 亞洲首間一站式臨床試驗學術研究機構Clinical
12、Trials Centre Clinical Trials Centre 臨床試驗中心臨床試驗中心Objective: To offer one-stop solutions to clinical trial sponsors and investigators 目標: 提供一站式服務予臨床試驗贊助商及研究員Board of Directors Board of Directors 理事會Clinical Trials Centre Clinical Trials Centre 臨床試驗中心Business and Development Business and Development 業
13、務發展Project Management Project Management 項目管理Site Management Site Management 研究基地管理Data Management and Medical Statistics Data Management and Medical Statistics 數據處理及統計分析Laboratory and Research Pharmacy Laboratory and Research Pharmacy 實驗室及藥品管理Education Education 教育及培訓Research and Consultation Resea
14、rch and Consultation 研究及諮詢Advisory CommitteeAdvisory Committee 諮詢委員會Faculty of Medicine Faculty of Medicine 醫學院Trial Network Management Trial Network Management 試驗網絡管理Organization Structure Organization Structure 組織架構組織架構Sponsors with a Master Clinical Trial Contract with HKU 部份已與香港大學訂定標準合約之贊助商Servi
15、ces Services 服務服務Research Consultation 研究諮詢Contract & Budget 合約及財務預算Regulatory Affairs 法規事務Subject Recruitment 受試者招募Site Management 研究基地管理Trial Monitoring 試驗監察Research Pharmacy 藥品管理Project Management 項目管理Data Management 數據處理Medical Statistics 統計分析Training & Education 教育及培訓Laboratory Services 實驗室服務Cl
16、inical Trials 臨床試驗CTC No. of Sponsored Trials Contracted Per Year 受贊助之臨床試驗總數(每年)Types of Trials by Therapeutic Area 按專科分類Types of Trials by Trial Phase 按臨床試驗期分類Type of clinical trials Type of clinical trials 臨床試驗之種類臨床試驗之種類CTC Types of Trials腫瘤科兒科泌尿科一期腸胃及肝臟科感染及 傳染科 血液科心臟科其他內分泌及新陳代謝科三期四期其他二期精神科5 clinical laboratories: Anatomical Pathology Clinical Biochemistry Clinical Immunology Haematology Microbiology 五大臨床實驗室： 組織及細胞病理 臨床生化
