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

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

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

Page 1: 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

Page 2: PROPOSAL FOR TIME-LINE AND ROAD-MAP OF STEM CELL R&D AND SERVICE AT RSCM/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

Page 3: PROPOSAL FOR TIME-LINE AND ROAD-MAP OF STEM CELL R&D AND SERVICE AT RSCM/FKUI.

-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

Page 4: PROPOSAL FOR TIME-LINE AND ROAD-MAP OF STEM CELL R&D AND SERVICE AT RSCM/FKUI.

-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

Page 5: PROPOSAL FOR TIME-LINE AND ROAD-MAP OF STEM CELL R&D AND SERVICE AT RSCM/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

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