It’s frequently found that the country where the study is conducted is different from the one where the company is located in or that more than one country or sponsor are involved in a single study. For the purpose of this DB to provide industrial development status, the country in any analysis provided in this website indicates where the current primary sponsoring company is located.
The year in any analysis provided in this website was determined based on the (planned) starting year of the study.
The anatomical organ or system affected by the disease is not always the same to those of therapeutic target. When there are more than one organ or system are involved, therapeutic target was chosen for the classification of indication over the anatomical localization of the lesion. For example, degenerative arthritis was classified as an orthopedic disease while rheumatoid arthritis was classified as an immune disorder.
In current DB, indication was classified into one of the following categories:
- Heart Heart disease
- Vascular Vascular disease
- Skin Skin disease
- GI Gastrointestinal disease
- Blood Hematologic disease
- Immune Immune disease
- Orthopedic Musculoskeletal disease
- Neuronal Neuronal disease
- Cancer Malignant disease
- Eye Eye disease
- Other Other
- Urologic Urologic disease
- Reproductive Reproductive system disease
- Lung Lung disease
- Genetic Genetic disease
Though there is a theoretical definition to differentiate the study phase, no definitive rules to define the phase of a study exists in a real-world setting. Therefore, the phase in this DB mirrors as claimed on the source registry by the registrant, which includes Phase I, I/II, II, II/III, and III.
■ Cell Origin
Depending on the cell origin, study treatments are classified into autologous (collected from an identical individual), allogeneic (collected from a different donor), or xenogenic (collected from an organism of a different species).
■ Cell Type
Though there is still a controversy over the definition of type of stem cells, cell type was classified as follows considering the claims by the study registrant found in the source registry and generally acceptable terms:
■ Cell Source
- HSC Hematopoietic stem cell
- MSC Mesenchymal stromal/stem cell
- NSC Neural stem cell
- ESC-derived Embryonic stem cell derived
- Others Others
The source where the stem cell was collected was classified into following categories:
■ Manipulation Type
- BM Bone marrow
- CB Cord blood
- Adipose Adipose tissue
- PB Peripheral blood
- ESC Embryonic stem cells
- Others Others
Study treatments are frequently associated with a range of ex vivo manipulation of the stem cells in addition to the most commonly used process, selection and in vitro expansion. In this DB, manipulation type indicates the additional manipulation type to the common process of selection and in vitro expansion that is referred to as selection and ex vivo expansion, as follows:
The StemCreDB is operated by the Center for Evaluating Next-Generation Stem Cell-based Therapeutics (CENST) and funded by the Ministry of Food & Drug Safety (MFDS) in Korea.
Copyright 2016 CENST all rights reserved.
- expansion selection, ex vivo expansion, selection
- differentiation differentiation, pre-conditioning
- gene-modified gene modification
- multi-population multiple cell population
- tissue-engineered tissue-engineering
- combination combined with device
- device companion device