Written Exam Assessing knows and knows how Departemen Obstetri dan Ginekologi FKUI-RSCM.
PROPOSAL FOR TIME-LINE AND ROAD-MAP OF STEM CELL R&D AND SERVICE AT RSCM/FKUI.
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Transcript of 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 ATRSCM/FKUI
Optimizationof availableculture techniques
-Stem cell identification and isolation-Stem cell amplification-Stem cell differentiationUSING AVAILABLE TECHNIQUESFEASIBLE TO BEPERFORMED IN CURRENTLY AVAILABLE FACILITIES
Clinical trial independentto the availability of RSUPNCM clean room facility
-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 APPLICATION ARM
LABORATORY RESEARCH ARM
I II III IV V
Submission and
Evaluation of proposals
Design and construction of facilities, Establishment
of Administration andManagerial System, Legal
System, Ethical Guidelines
Utilization of Research Facilities (including animal facilities) and Service Facilities for Cord Blood Banking
Utilization of Service facilities for Clinical Trial
Utilization of Service facilities for patient service
-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
Optimizationof availableculture techniques
-Stem cell identification and isolation-Stem cell amplification-Stem cell differentiationUSING AVAILABLE TECHNIQUESFEASIBLE TO BEPERFORMED IN CURRENTLY AVAILABLE FACILITIES
Clinical trial independentto the availability of RSUPNCM clean room facility
Optimization of Patented Techniques for PatientService and Establishment of GMP and GCP
-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.
Amplification studiesDifferentiation studiesCancer stem cell studies
-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)
CLINICAL APPLICATION ARM
LABORATORY RESEARCH ARM
I II III IV V
Submission and
Evaluation of proposals
Design and construction of facilities, Establishment
of Administration andManagerial System, Legal
System, Ethical Guidelines
Utilization of Research Facilities (including animal facilities) and Service Facilities for Cord Blood Banking
Utilization of Service facilities for Clinical Trial
Utilization of Service facilities for patient service
-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.
Optimizationof availableculture techniques
-Stem cell identification and isolation-Stem cell amplification-Stem cell differentiationUSING AVAILABLE TECHNIQUESFEASIBLE TO BEPERFORMED IN CURRENTLY AVAILABLE FACILITIES
Clinical trial independentto the availability of RSUPNCM clean room facility
Optimization of Patented Techniques for PatientService and Establishment of GMP and GCP
Amplification studiesDifferentiation studiesCancer stem cell studies
-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)
Scaffold Design and Utilization of Animal Models
Safety and Efficacy Studies
Exploration of stem cell utility for other purposes:-Pharmacogenomic/genetic studies-Immunopathogenesis and infection studies
Aplication of patented techniques for Clinical Trial and banking service
-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
CLINICAL APPLICATION ARM
LABORATORY RESEARCH ARM
I II III IV V
Submission and
Evaluation of proposals
Design and construction of facilities, Establishment
of Administration andManagerial System, Legal
System, Ethical Guidelines
Utilization of Research Facilities (including animal facilities) and Service Facilities for Cord Blood Banking
Utilization of Service facilities for Clinical Trial
Utilization of Service facilities for patient service
Optimizationof availableculture techniques
-Stem cell identification and isolation-Stem cell amplification-Stem cell differentiationUSING AVAILABLE TECHNIQUESFEASIBLE TO BEPERFORMED IN CURRENTLY AVAILABLE FACILITIES
Clinical trial independentto the availability of RSUPNCM clean room facility
Optimization of Patented Techniques for PatientService and Establishment of GMP and GCP
Amplification studiesDifferentiation studiesCancer stem cell studies
-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)
Scaffold Design and Utilization of Animal Models
Safety and Efficacy Studies
Exploration of stem cell utility for other purposes:-Pharmacogenomic/genetic studies-Immunopathogenesis and infection studies
Aplication of patented techniques for Clinical Trial and banking service
-Cardiovascular-Cartilage and Bone-Neurologic disorder-Etc.
CLINICAL APPLICATION ARM
LABORATORY RESEARCH ARM
I II III IV V
Submission and
Evaluation of proposals
Design and construction of facilities, Establishment
of Administration andManagerial System, Legal
System, Ethical Guidelines
Utilization of Research Facilities (including animal facilities) and Service Facilities for Cord Blood Banking
Utilization of Service facilities for Clinical Trial
Utilization of Service facilities for patient service
Use of Service Facilities for PatientService/Clinical Trials