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Overview

TCTC

Cell therapy uses cultured or processed human cells to rebuild human structures, functions, or treat diseases. Cell therapy is divided into two types: Immune cell therapy and stem cell transplantation. Immune cell therapy is a type of cancer treatment, mainly by stimulating the immune cells to enhance the anti-tumor capability to fight cancer. Stem cells, including embryonic stem cells/induced pluripotent stem cells (ESC/iPSC), mesenchymal stem cells (MSC) and hematopoietic stem cells (HSC), can differentiate and develop into blood, brain, bone, and various organs of the body to replace or repair damaged tissues or cells of patients. In order to facilitate more clinical trials of cell therapy and integrate the clinical studies in Taiwan, Taiwan Cell Therapy Clinical Trial Consortium (TCTCTC) was established. We aim for the following objectives:

  1. To promote industry-academy cooperation between biotechnology pharmaceutical companies and basic medical science and clinical medical research teams.
  2. To assist the implementation of clinical trials and translation studies in industries and basic research teams.
  3. To enhance the international competitiveness in the field of cell therapy, we will help every cell therapy center to acquire the certification of the facility, and to accelerate the review of clinical trial of cell therapy.
  4. To establish or review the standard operating procedures of cell collection and cell infusion in each cell therapy center.
  5. To invite the distinguished speakers for academic seminars, in order to promote more clinical studies of cell therapy.

Strengths

TCTC

According to the information from ClinicalTrials.gov and Center for Drug Evaluation (CDE), it points out some characteristics in clinical trials of cell therapy in Taiwan. First, there is no consistency in the types of cell therapy. Second, indications of the studies are various. Third, most of the clinical trials are executed at one hospital rather than multicenter.In TCTCTC, there are several categories of stem cell therapy, including hematopoietic stem cell (HSC), mesenchymal stem cells (MSC) and adipose-derived stem cells. One of our team members is specialized in hematopoietic CD34+ stem cells to treat cardiac infarction, stroke, arterial disease. There are several team members specialized in MSCs for respiratory distress syndrome, osteoarthritis. Adipose-derived stem cells are used to treat the patients with chronic stroke.Immune cell therapy consists of natural killer cells (NK cells), cytokine-induced killer cells (CIK cells) and dendritic cells, etc. One member uses NK cells combined with Gefitinib or Erlotinib for the treatment of late stage lung cancer. Another team member utilizes CIK cells to treat late stage lung cancer unresponsive to targeted therapy. Autologous dendritic cell vaccination was used as an Add-On treatment for primary glioblastoma Multiforme (GBM).

Type Number Product name or cell type of clinical trial
Global Trials 1
Phase III 1 Autologous cytotoxic T lymphocytes
Local Trials 8
Phase I 4 Active T cell, NK cell, CIK, MSC
Phase II 1 Dendritic cell
Phase III 1 CLS2702C/CLS2702D
Others 2 MSC, adipose-derived stem cell
IIT 13
Phase I 8 CD34+ stem cell, blood monocyte
Phase II 3 CD34+ stem cell, adipose-derived stem cell
Phase III 1 Hematopoietic stem cell
Others 1 MSC

Major Achievements

TCTC

Establishment of Taiwan Cell Therapy Clinical Trial Consortium in 2019. The members are listed below:

Name of participating Sites Abbreviated Name Name of Co-PI
1 National Taiwan University Hospital NTUH Ming Yao
2 National Taiwan University Cancer Center NYUCC Jih-Luh Tang
3 Taipei Veterans General Hospital VGHTP Shih-Hwa Chiou
4 Taipei Medical University Hospital TMUH Kuan-Der Lee
5 Linkou Chang Gung Memorial Hospital CGMH-LK Tung-Her Jaing
6 China Medical University Hospital CMUH Der-Yang Cho
7 National Cheng Kung University Hospital NCKUH Tsai-Yun Chen
8 E-DA Hospital EDAH Chao-Sung Chang
9 Kaohsiung Medical University Hospital KMUH Deng-Chyang Wu
10 Kaohsiung Chang Gung Memorial Hospital CGMH-KH Hon-Kan Yip
11 Hualien Tzu Chi Hospital HL-TZH Chi-Cheng Li

Members

TCTC

National Taiwan University Cancer Center

Chang Gung Memorial Hospital, Kaohsiung

National Cheng Kung University Hospital

Taipei Medical University Hospital

Hualien Tzu Chi Hospital

National Cheng Kung University Hospital

Chang-Gung Memorial Hospital, Linkou

National Taiwan University Hospital

Kaohsiung Medical University Hospital

China Medical University Hospital

Taipei Veterans General Hospital