Fibroblasts Touted as Scalable Alternative to Stem Cells
Pete O’Heeron, CEO of FibroBiologics, positioned fibroblast-based therapies as a potentially superior alternative to stem cells for regenerative medicine. He argued that fibroblasts offer significant advantages in cost, manufacturing scalability, and immunology, potentially enabling off-the-shelf solutions that are easier to harvest and expand.
- Fibroblasts exhibit a faster proliferation rate, with a doubling time of about 24 hours compared to 48 hours or more for mesenchymal stem cells (MSCs), and can be expanded for more than 50 doublings without entering senescence. This inherent stability and rapid growth in culture can lead to lower production costs and faster timelines for developing cell-based therapies. - Unlike MSCs, which are rare in bone marrow (1 in 10,000 to 100,000 nucleated cells), fibroblasts are abundant and easily harvested from tissues like skin or from surgical waste, streamlining the sourcing process. Their robustness and less stringent culture media requirements further reduce manufacturing complexity and cost compared to stem cells. - FibroBiologics is advancing an allogeneic fibroblast therapy, CYWC628, for diabetic foot ulcers, with a Phase 1/2 clinical trial slated to begin in Australia in the first quarter of 2026. The company has secured Human Research Ethics Committee (HREC) approval for the 120-patient study and expects topline results before the end of the year. - Beyond wound healing, FibroBiologics' pipeline includes IND-enabling studies for psoriasis and multiple sclerosis. Preclinical studies for their psoriasis candidate, CYPS317, showed efficacy comparable to existing biologics in acute models. A previously completed first-in-human Phase 1 trial for multiple sclerosis demonstrated a clean safety profile with no adverse events. - From a biomanufacturing perspective, the shift towards allogeneic, "off-the-shelf" therapies, whether fibroblast or stem cell-based, is a key industry trend aimed at overcoming the logistical and cost barriers of autologous (patient-specific) treatments. This requires significant investment in GMP-compliant facilities, with recent build-outs costing between $80 million and $155 million. - The implementation of digital systems and automation is critical for scaling cell therapy manufacturing while ensuring quality and compliance. Advanced analytics, AI, and digital twins are being used to create data-driven process control and predictive manufacturing, while automated, closed systems for cell harvesting and expansion reduce manual labor and contamination risks. - Data management and standardization remain significant hurdles in cell and gene therapy manufacturing, with data often fragmented across disparate systems. Initiatives are underway to establish common data standards and best practices for data management throughout the product lifecycle to ensure process transparency, support continued process verification (CPV), and facilitate regulatory reporting. - Fibroblasts play an active role in the immune system, capable of both promoting and suppressing immune responses depending on the context. They can suppress T-cell activation and stimulate the formation of T regulatory cells, while also secreting chemokines and cytokines that recruit and activate other immune cells, making them a versatile tool for immunomodulation.
