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Advanced Regenerative Medicine

Introduction of Advanced Regenerative Medicine

Cell Therapy

Gene therapy

  • Taken Cells from the patient

  • Inject DNA modified with disease-curing genetic informationinto the cells (sometimes inject modified viruses into the cells)

  • Inject the modified cells back into the patient’s body

  • Cells function and cure the disease

Tissue therapy

Convergence therapy

A medical treatment that combines a medical treatment such as cell therapy, gene therapy, tissue engineered therapy, and medical devices specified in Article 2 (1) of the Medical Devices Act in physical and chemical manners

Terminology

Advanced Regenerative Medicine

  • Emerging therapeutic method that aims to reconstruct human tissues and organs to improve quality of life and disease treatment.

Advanced Biopharmaceuticals

  • Licensed drugs containing human cells, including cell therapies, gene therapies and tissue engineered products.

Clinical Research on Advanced Regenerative Medicine

  • Academic purposes
  • Clinical Research on Advanced Regenerative Medicine
  • Review by the Advanced Regenerative Medicine and Advanced Biological Products Review Committee
  • Conducted by the advanced regenerative medicine implementation institutions

Advanced Biopharmaceuticals Clinical Research

  • Commercial purposes
  • Clinical trials on commercial drugs
  • Review by the Ministry of Food and Drug Safety
  • Conducted by clinical trial implementation institutions

Clinical Research on Advanced Regenerative Medicine Management

Flow Chart of Affairs Related to Clinical Research on Advanced Regenerative Medicine

  • Designate as advanced regenerative medicine implementation institutions

  • Apply for review on clinical research plan

  • Accepted by Secretariat/Review by Professional Review Boards

  • Approval for clinical research

  • Clinical research/ Reporting

  • Final report submitted

  • Long-term follow-up

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