FibroBiologics will enroll 120 patients across 10 Australian sites in a randomized Phase 1/2 trial of CYWC628, a topically administered allogeneic fibroblast cell therapy for refractory diabetic foot ulcers. Participants will receive up to 12 weeks of treatment with standard of care alone or standard of care plus either a low or high dose of CYWC628, with an interim analysis planned once a predefined subset has completed six weeks to assess initial safety and efficacy signals.
The company has secured both public and private HREC approvals and completed its Therapeutic Goods Administration filing, clearing the study to start. Southern Star Research will run the trial end to end across Australia. The protocol focuses on wound-healing outcomes, response durability, and safety through serial clinical and imaging assessments, positioning the study to generate data that can guide dose selection and operational feasibility for a larger program.
Strategically, launching first in Australia leverages predictable ethics timelines and cost-efficient start-up in a jurisdiction that has become a frequent choice for early cell and gene therapy studies. The design blends dose-finding with a pragmatic comparator arm aligned to routine care, a practical approach in DFU where site-to-site variability in dressings, debridement, and off-loading can confound readouts. CYWC628’s topical, allogeneic format is a deliberate attempt to lower barriers seen with more complex tissue constructs or autologous products, shifting the complexity upstream to manufacturing while simplifying site workflows.
For sites, the operational footprint is familiar wound clinic terrain: frequent visits over 12 weeks, standardized debridement and off-loading, and rigorous, reproducible imaging. The topical administration could minimize specialized handling requirements if the product ships ready-to-apply; however, sites will need clear SOPs around storage, chain of custody, and timing relative to debridement to reduce protocol deviations. Recruiting 120 refractory patients is meaningful in this indication, where exclusions for infection, ischemia, and glycemic control can slow accrual; success will depend on tapping high-volume podiatry and vascular centers and maintaining consistent standard-of-care practices across the network. CRO oversight of imaging and endpoint adjudication will be critical to mitigate noise that has undermined past DFU programs.
For sponsors and CROs, the study underscores a broader trend: early, dose-ranging cell therapy trials moving to jurisdictions with faster ethics clearance, followed by bridging to U.S. and EU once a signal emerges. If CYWC628 shows a credible early efficacy and safety profile, the company could pursue an adaptive expansion or a cleaner Phase 2b with a single selected dose and tighter wound stratification. Regulators will look for clarity on potency assays, batch consistency, sterility, and cold-chain reliability—recurring pressure points for allogeneic cell products that can overshadow clinical signal if unresolved.
The near-term watchlist is straightforward: the specifics of the interim analysis plan, the definition and adjudication of primary wound endpoints, and the pace of enrollment across the 10 sites. The bigger questions sit downstream: whether a topical fibroblast therapy can deliver reproducible closure rates beyond optimized standard care, how manufacturing scalability and release testing will hold up under multi-site demand, and how Australian data will translate to U.S. regulatory expectations in a BLA pathway. If the signal is strong, expect a fast follow-on protocol with tighter inclusion criteria and centralized imaging to de-risk variability; if it’s marginal, the company will need to consider combination logic or refined patient selection to stay competitive in a crowded advanced wound-care landscape.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
