KFCI is a screening platform by quantification of molecular biomarkers.
Technology Overview
Current cell therapy research relies on manual safety assessments of donor cells, lacking data on cell precision biological properties. Later clinical trials often reveal unsuitable cell samples, leading to substantial time and resource wastage. To fill the gap in cell efficacy assessment, ITRI has established a donor-screening technology platform Key Functional Cell Identity (KFCI) to select and quantify donor cell lines with the most specific functions by designing molecular biomarkers related to immune regulation, angiogenesis, and tissue regeneration. In addition, these cell activities are evaluated to confirm angiogenic and immunomodulatory properties with cell-based assays. In pig myocardial infarction study demonstrated significant improvement in cardiac function and necrotic areas. Also, the treatment of diabetic wounds in rats reduced wound healing time by one-third. Both of these cell products are currently in clinical trial.
KFCI offers a novel clinical screening platform to manage source quality and precision efficacy of cells from donors. The innovation can boost the industrial growth of regenerative medicine, driving cell therapy development with higher efficiency to rejuvenate organ functions, lower costs, and faster adoption rates. Furthermore, severe patients could find suitable, safe, and efficient cell therapy to improve their overall health without waiting.
Applications & Benefits
- Precise Cell Identification: KFCI is a quick and effective screening platform for super donor cells. It significantly improves the clinical success rate.
- Cost-Efficiency: KFCI reduces expenses to an estimated 1/10 of current cell therapeutics by filtering out unusable cells.
- Scalability: KFCI can produce 100,000–500,000 doses of cell product per donor. The biggest benefit of cost reduction is improved affordability.
- Adaptability: KFCI's potential integration with AI and biochips promises an expedited screening process, with the anticipation of achieving one-second identification.
Contact
Subcutaneous transplantation of allogenic MSCs into DM rat improve wound healing.
MSCs accelerate diabetic wound rat by inhibiting inflammation and enhancing angiogenesis and tissue regeneration.
Early intracoronary transplantation of allogenic MSCs into AMI mini-pig improve heart function.
MSCs transplantation decreased the infarcted heart region (yellow frame).
One-Stop Biomedical Services
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- Listing Regulations Consulting: FDA/TFDA/CE application, medical device verification/export, medical device/medicine registration, IRB document organization, clinical trial application, and more.
- Technology Transfer: Bio-IT, diagnostics and precision medicine technology, regeneration medicine technology, natural medicine and healthcare technology, targeted drug and delivery technology.
- Model Translation: Domestic supply chain linkage, medical device design control, market analysis, strategy analysis of regulation in commercialization, and more.
- Preclinical/Clinical Trial: Functional safety assessments, clinical research organization linkage, clinical evaluation and analysis, clinical trial planning, clinical trial analysis and reports.
- Other Services: Quality system consulting, commercialization consulting, smart health solutions, software validation, medical device risk management, information security risk evaluation, technical documents preparation, business ecosystem linkage, and more.