Research and development
The patent of the mentioned nanotechnology as “Growth Factor-Free Proliferation and Differentiation of Neural Stem Cells on Inorganic Extracellular Nanomatrices” was filed in three regions, namely USA Non-Provisional Patent (Application Serial No.: 15/600,808), European (Application No.: 17802132.5) and China (Application No.: 201780031011.8). Our technology has published in the influential science journal, namely Advanced Science with the impact factor as 15.8 (DOI: 10.1002/advs.201901822).
Our company has begun to prepare for the US Food and Drug Administration (FDA) certification for products, and we have produced a US Regulatory Strategy Report for our products through third parties. According to the report, our product belongs to the FDA product number KIZ. It is very likely to be exempted from 510(k) or PMA application and directly licensed for clinical use.
Preliminary clinical trials are expected to perform after our product was successfully approved as medical devices by the U.S. food and drug administration (FDA) or China food and drug administration (CFDA). This technology will provide an useful medical device to specifically create functional cells for NSC therapies for patients with neurological diseases (e.g. Parkinson's disease) upon regulatory bodies’ approval for clinical applications.
In addition to culturing and differentiating neural stem cells for neurodegenerative care, other types of stem cells can be tried to treat a variety of different degenerative diseases. For example, try to culture mesenchymal stem cells in our product to safely proliferate and differentiate into chondrocytes or ligament cells to repair damaged areas of patients with degenerative joint diseases and improve their mobility. Osteoarthritis is a degenerative disease of joints with destruction of articular cartilage associated with subchondral bone hypertrophy and inflammation, resulting in significant worsening of the quality-of-life in the elderly.
As reported by WHO, 9.6% of men and 18.0% of women aged over 60 years in worldwide have symptom of degenerative joint disease. There is no cure for arthritis but the most commonly treatment is using drugs to ease inflammation and related pain. Current clinical trials on stem cell therapy are still at early stages to evaluate safety, feasibility and efficacy. A huge and potential market of our novel nanomaterials can be foreseen.