The cellulose-based dermal filler has received Health Canada authorization to begin clinical trials evaluating its safety and performance in tissue augmentation.
Spiderwort Biotechnologies Inc has received Investigational Testing Authorization from Health Canada to initiate a human clinical trial of its investigational dermal filler, CelluJuve. The company is developing the product as a cellulose-based alternative for tissue augmentation and facial rejuvenation.
The authorization allows Spiderwort to begin evaluating the safety and performance of CelluJuve in human subjects. The trial will assess how the material interacts with human tissues, building on the company’s prior completion of ISO 10993 biocompatibility testing and human skin safety evaluations.
“This achievement validates our rigorous development approach and accelerates our path toward bringing CelluJuve to patients and clinicians who are seeking innovative alternatives in dermal fillers. We’re excited to begin the clinical evaluation phase and demonstrate the potential benefits of our cellulose-based technology Aerocel in medical aesthetics and beyond,” says Charles M. Cuerrier, PhD, CEO of Spiderwort Biotechnologies, in a release.
‘Alternative Method to Address’ Facial Aging
Joely Kaufman, MD, FAAD, a board-certified dermatologist and member of Spiderwort’s Clinical Advisory Board, notes that the approach may offer a new method for addressing facial aging. “The preliminary data suggests that this cellulose-based technology could potentially offer an alternative method to address the signs of facial aging,” says Kaufman in a release.
CelluJuve is being developed for use in aesthetic medicine, initially targeting nasolabial fold remediation. The product is designed to act as a scaffold for collagen deposition, potentially supporting a natural look and feel.
Spiderwort’s ISO 5 cleanroom facility, announced earlier this year, will be used to manufacture clinical-grade CelluJuve for the upcoming trials. The company notes that the facility meets the quality standards required for materials used in human studies.
“We’re demonstrating how plant-derived biomaterials can become a powerful foundation to address a variety of medical needs,” says Andrew Pelling, PhD, chief science officer at Spiderwort, in a release. “These recent and critical regulatory advancements in our product portfolio reveal how nature-inspired innovation can unlock entirely new frontiers in rejuvenating and regenerating human tissues.”
CelluJuve is currently under investigation and has not been approved for commercial use by Health Canada or the US Food and Drug Administration. Its safety and effectiveness will be evaluated through forthcoming clinical trials.
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