The current method of treating cartilage damage is cell therapy. The key to the success of this cell-based treatment is whether the characteristics of hyaline cartilage can be retained in the process of cultivating hyaline cartilage. There are two main treatments. One is a solution based on stem cells, but the existing technology cannot effectively direct multifunctional stem cells to chondrocytes, so the implanted cells eventually form mixed cells without biomechanical characteristics; the other is based on cartilage tissue. Adult-derived technology, in most cases, obtains cells from the cartilage tissue of the patient itself (ACI), but adult-derived chondrocytes easily lose their phenotype and transform into a scar tissue (dedifferentiation), which also lacks basic Cartilage biomechanical characteristics.
In order to cultivate characteristic hyaline cartilage, it is necessary to use the cartilage precursor existing in the center of human bone growth. However, since the bone growth center in the human body disappears from childhood to adulthood, traditional techniques cannot extract effective cultivation materials.
The company proposed a biological solution that can regenerate cartilage. This solution uses the only available cartilage precursor cells from a heterologous gene source, and implants the cartilage precursor cells to ensure the original biomechanical characteristics of the damaged joint, thereby achieving The effect of repairing cartilage damage is conducive to the recovery of injured knee.
This gelatinous perichondrium, which can be transplanted to the damaged area, can continue to grow in the damaged area and is distinguished from normal hyaline cartilage, filling the damaged area while binding to the damaged tissue.
The technical team found a unique anatomical growth center in the mini-pig-the mandibular condyle (MC). Chondrocytes collected from the 7th day of the newborn SPF mini-pig mandibular condyle can spontaneously grow and produce Patented transparent cartilage tissue.
Status of Technology Maturity
The company has now completed pre-clinical use, using goats as experimental subjects to prove its effectiveness, and performing allotransplantation on primates to prove its safety.
The project has been evaluated by EMEA (European Drug Evaluation Agency) and has been approved for Phase I / II clinical studies. At the same time, the project has established detailed quality assurance (QA) / quality control (QC) analysis, assessing the effectiveness and safety of the product, and formulated a SOP agreement that complies with GMP production requirements, as well as IMPD and IB documents.
The implants grow together with the host tissue as real articular cartilage, and related research results have been submitted to European regulatory agencies and approved for human clinical trials.
The project accepts equity investment and funds are used to conduct human clinical trials. At present, the team is looking for Chinese strategic partners and Chinese investors with channel resources and medical industry background to put this technology project into the Chinese market.
If you want to cooperate further with the project, please contact email@example.com .