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PROPOSAL FOR TIME-LINE AND ROAD-MAP OF STEM CELL R&D AND SERVICE AT RSCM/FKUI

PROPOSAL FOR TIME-LINE AND ROAD-MAP OF STEM CELL R&D AND SERVICE AT RSCM/FKUI. Utilization of Research Facilities (including animal facilities) and Service Facilities for Cord Blood Banking. Design and construction of facilities, Establishment of Administration and Managerial System, Legal

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PROPOSAL FOR TIME-LINE AND ROAD-MAP OF STEM CELL R&D AND SERVICE AT RSCM/FKUI

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  1. PROPOSAL FOR TIME-LINE AND ROAD-MAP OF STEM CELL R&D AND SERVICE ATRSCM/FKUI

  2. Utilization of Research Facilities (including animal facilities) and Service Facilities for Cord Blood Banking Design and construction of facilities, Establishment of Administration and Managerial System, Legal System, Ethical Guidelines Submission and Evaluation of proposals Utilization of Service facilities for Clinical Trial Utilization of Service facilities for patient service II III IV V I CLINICAL APPLICATION ARM -Cardiovascular therapy utilizing mesenchymal stem cell from PBMC (Stem Cell isolation protocol should be subjected to evaluation by biosafety/patient safety committee) -Bone marrow stem cell/chondrocytes therapy for generation of cartilage Clinical trial independent to the availability of RSUPNCM clean room facility Optimization of available culture techniques • Stem cell identification • and isolation • Stem cell amplification • Stem cell differentiation • USING AVAILABLE • TECHNIQUES • FEASIBLE TO BE • PERFORMED IN • CURRENTLY • AVAILABLE FACILITIES LABORATORY RESEARCH ARM

  3. Utilization of Research Facilities (including animal facilities) and Service Facilities for Cord Blood Banking Design and construction of facilities, Establishment of Administration and Managerial System, Legal System, Ethical Guidelines Submission and Evaluation of proposals Utilization of Service facilities for Clinical Trial Utilization of Service facilities for patient service II III IV V I CLINICAL APPLICATION ARM • Optimization and Establishment of patented techniques: • Amplification (laboratory) • Stem Cell Delivery (clinical) • Establishment of systems for implementation of GLP, GMP and GCP:Lab, Clinic, Administration,n Managerial, Legal, Etc. -Cardiovascular therapy utilizing mesenchymal stem cell from PBMC (Stem Cell isolation protocol should be subjected to evaluation by biosafety/patient safety committee) -Bone marrow stem cell/chondrocytes therapy for generation of cartilage Optimization of Patented Techniques for Patient Service and Establishment of GMP and GCP Clinical trial independent to the availability of RSUPNCM clean room facility Optimization of available culture techniques Amplification studies Differentiation studies Cancer stem cell studies • Stem cell identification • and isolation • Stem cell amplification • Stem cell differentiation • USING AVAILABLE • TECHNIQUES • FEASIBLE TO BE • PERFORMED IN • CURRENTLY • AVAILABLE FACILITIES • R&D in amplification of adult Stem Cell (including generation and amplification of induced pluripotent stem cells) • R&D in differentiation into various tissues • R&D in cancer stem cell (role in cancer pathogenesis, development of diagnostic and theurapeutic system) LABORATORY RESEARCH ARM

  4. Utilization of Research Facilities (including animal facilities) and Service Facilities for Cord Blood Banking Design and construction of facilities, Establishment of Administration and Managerial System, Legal System, Ethical Guidelines Submission and Evaluation of proposals Utilization of Service facilities for Clinical Trial Utilization of Service facilities for patient service II III IV V I CLINICAL APPLICATION ARM • Banking • Autologous Adult Stem Cell • Cord Blood? • Application of patented Stem Cell Sorting and Amplification for clinical trial • Clinical Trial of Patented Stem Cell Therapy: • Safety Evaluation • Efficacy • Optimization and Establishment of patented techniques: • Amplification (laboratory) • Stem Cell Delivery (clinical) • Establishment of systems for implementation of GLP, GMP and GCP:Lab, Clinic, Administration,n Managerial, Legal, Etc. Aplication of patented techniques for Clinical Trial and banking service Optimization of Patented Techniques for Patient Service and Establishment of GMP and GCP Clinical trial independent to the availability of RSUPNCM clean room facility Optimization of available culture techniques Scaffold Design and Utilization of Animal Models Amplification studies Differentiation studies Cancer stem cell studies • Stem cell identification • and isolation • Stem cell amplification • Stem cell differentiation • USING AVAILABLE • TECHNIQUES • FEASIBLE TO BE • PERFORMED IN • CURRENTLY • AVAILABLE FACILITIES • R&D in amplification of adult Stem Cell (including generation and amplification of induced pluripotent stem cells) • R&D in differentiation into various tissues • R&D in cancer stem cell (role in cancer pathogenesis, development of diagnostic and theurapeutic system) Safety and Efficacy Studies • Exploration of stem cell utility for other purposes: • Pharmacogenomic/genetic studies • Immunopathogenesis and infection studies LABORATORY RESEARCH ARM

  5. Utilization of Research Facilities (including animal facilities) and Service Facilities for Cord Blood Banking Design and construction of facilities, Establishment of Administration and Managerial System, Legal System, Ethical Guidelines Submission and Evaluation of proposals Utilization of Service facilities for Clinical Trial Utilization of Service facilities for patient service II III IV V I CLINICAL APPLICATION ARM • Cardiovascular • Cartilage and Bone • Neurologic disorder • Etc. Use of Service Facilities for Patient Service/Clinical Trials Aplication of patented techniques for Clinical Trial and banking service Optimization of Patented Techniques for Patient Service and Establishment of GMP and GCP Clinical trial independent to the availability of RSUPNCM clean room facility Optimization of available culture techniques Scaffold Design and Utilization of Animal Models Amplification studies Differentiation studies Cancer stem cell studies • Stem cell identification • and isolation • Stem cell amplification • Stem cell differentiation • USING AVAILABLE • TECHNIQUES • FEASIBLE TO BE • PERFORMED IN • CURRENTLY • AVAILABLE FACILITIES • R&D in amplification of adult Stem Cell (including generation and amplification of induced pluripotent stem cells) • R&D in differentiation into various tissues • R&D in cancer stem cell (role in cancer pathogenesis, development of diagnostic and theurapeutic system) Safety and Efficacy Studies • Exploration of stem cell utility for other purposes: • Pharmacogenomic/genetic studies • Immunopathogenesis and infection studies LABORATORY RESEARCH ARM

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