The establishment and application of safety evaluation and key technology research system for modem Chinese herbal drug / 中国比较医学杂志

The adverse reactions caused by traditional Chinese medicine have occurred frequently, but there is a lack of scientific,objective and standardized methods for safety evaluation of traditional Chinese medicine.In the process of preclinical evaluation of traditional Chinese medicine, it is imperative to form a set of scientific, standardized and feasible evaluation system of modem Chinese herbal drug.We established the preclinical safety evaluation system of modem Chinese herbal drug including the quality control system of samples for the preclinical safety evaluation, the toxicity evaluation system of modem Chinese herbal drug and its preparation and the evaluation management system, and standardized each research link of preclinical evaluation of traditional Chinese medicine.Whether from protecting patients' health and increasing the safety of clinical medication, or from enriching and improving traditional Chinese medicine science, developing traditional Chinese medicine and promoting mutual connection of traditional Chinese medicine and international medicine, it has important instructional significance and application value.

Pre-Clinical Efficacy and Safety Evaluation of Human Amniotic Fluid-Derived Stem Cell Injection in a Mouse Model of Urinary Incontinence

PURPOSE: Stem cell-based therapies represent new promises for the treatment of urinary incontinence. This study was performed to assess optimized cell passage number, cell dose, therapeutic efficacy, feasibility, toxicity, and cell trafficking for the first step of the pre-clinical evaluation of human amniotic fluid stem cell (hAFSC) therapy in a urinary incontinence animal model. MATERIALS AND METHODS: The proper cell passage number was analyzed with hAFSCs at passages 4, 6, and 8 at week 2. The cell dose optimization included 1x10(4), 1x10(5), and 1x10(6) cells at week 2. The in vivo cell toxicity was performed with 0.25x10(6), 0.5x10(6), and 1x10(6) cells at weeks 2 and 4. Cell tracking was performed with 1x10(6) cells at weeks 2 and 4. RESULTS: The selected optimal cell passage number was smaller than 6, and the optimal cell dose was 1x10(6) for the mouse model. In our pre-clinical study, hAFSC-injected animals showed normal values for several parameters. Moreover, the injected cells were found to be non-toxic and non-tumorigenic. Furthermore, the injected hAFSCs were rarely identified by in vivo cell trafficking in the target organs at week 2. CONCLUSION: This study demonstrates for the first time the pre-clinical efficacy and safety of hAFSC injection in the urinary incontinence animal model and provides a basis for future clinical applications.

From Idea to Product

No abstract available.

Preclinical evaluation of prototype products

Preclinical evaluation of medical devices (prototype products) offers the opportunity to investigate and study the intended use of device materials. Preclinical evaluation programs are designed to determine the efficacy, safety, and biocompatibility of biomaterials, prostheses, and medical devices. The purpose of safety testing is to determine if a material presents potential harm to the human; it evaluates the interaction of the material with the in vivo environment and determines the effect of the host on the implant. Preclinical evaluation is the determination of the ability of the prototype product to perform with appropriate host response in a specific application, considered from the perspective of human clinical use. Therefore, preclinical data should include materials science and engineering, biology, biochemistry, medicine, host reactions and their evaluation, the testing of biomaterials, and the degradation of materials in a biological environment.