Target Product Profile (TPP)
- Diseases for which indication is efficacious: Chronic Stroke (blue ocean where market has not been created yet) → First-in-Class therapy
- Formation: Homograft, off-the-shelf, and cells suspended in saline solution
- Functions: Regenerate blood vessel and also re-construct damaged cephalin with complex functions promoting the generation and differentiation of nerve cells
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Validity
Regenerate blood vessel and also re-construct
damaged cephalin with complex functions
p romoting the generation and differentiation of nerve cells
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Safety
Formation to be injected in the operation room in generic class as the final formation is in the form of cells by minimizing the risk from introgressed genes by using 3rd generation lentivirus
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Productivity
Convenient for commercialization with possible mass production of cells with consistent features single introgression of genes
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Business
profitability
Convenient delivery as an off-the-shelf that cells with consistent and high quality can be provide in
the research for clinical phase 3 performed by many institutions. Therefore, it is possible to increase the success rate of clinical
phase 3 test.
※ STEPS3 (Stem Cells as an Emerging Paradigm in Stroke, 2014, FDA, NIH) Transplant to animal model 1 month afterward and to patents 6 months afterwards
※ MCB (master cell bank)
Product Efficacy
- Restore kinetic function by improving brain microenvironment that is devastated in animal models with stroke
※ STEPS3 (Stem Cells as an Emerging Paradigm in Stroke, 2014, FDA, NIH) Transplant to animal model 1 month afterwards and to patients 6 months afterwards