Spiderwort Biotechnologies INC has received the authorization of research tests from Health Canada to start a human clinical trial of its dermal research filling, Celujuve. The company is developing the product as a cellulose -based alternative for the increase in tissues and facial rejuvenation.
Authorization allows Spiderwort to begin to evaluate the safety and performance of Celujuve in human subjects. The trial will evaluate how the material interacts with human tissues, based on the previous completion of the Biocompatrity Tests ISO 10993 and the safety evaluations of human skin.
“This achievement validates our rigorous development approach and accelerates our to lead to Celujuve to patients and doctors and doctors and doctors innovative in dermal fillings. We are excited to begin the benefits of technological aerocel based on cellulose based on the evaluation of cellulose in medical aesthetics and beyond”, beyond “, beyond Charles M. Cuerrier, PHD, PHD, CEO or SPIDER Wiotnology, in a launch.
‘Alternative method to address’ facial aging
Joly Kaufman, MD, FAAD, dermatologist certified by the Board and member of the Spiderwort Clinical Advisory Board, points out that the approach can offer a new method to address facial aging. “Preliminary data suggest that this cellulose -based technology could sacrifice an alternative method to address facial agial signs,” says Kaufman in a statement.
Celujuve is developing for use in aesthetic medicine, initially aimed at the remediation of the nasolabial fold. The product is designed to act as a scaffold for collagen deposition, potentially supporting a natural appearance.
The installation of ISO 5 cleaning room of Spiderwort, announced earlier this year, will be used to manufacture clinical degree cell for the next trials. The company indicates that the installation complies with the quality standards required for the materials used in humans.
“We are demonstrating how plant -derived biomaterials can become a powerful basis to address a variety of medical needs,” says Andrew Pelling, PHD, scientific director of Spiderwort, in a statement. “These recent and critical regulatory advances in our product portfolio reveal how innovation inspired by nature can unlock completely new borders in rejuvenation and regeneration of human tissues.”
Celujuve is currently under investigation and has not been approved for commercial use by Health Canada or the Food and Food Administration of the United States. Its safety and effectiveness will be evaluated through the next clinical trials.