Regenerative medicine is currently one of the main areas of research in neurological diseases, driven by increasing interest in the immunological mechanisms involved in nervous tissue repair. Within this context, research conducted by the Hemera team has highlighted the role of functionally reprogrammed macrophages in regenerative processes, forming the basis for the development of REMaST, an advanced cell therapy for spinal cord injuries, a condition for which no definitive treatments are currently available.
The preclinical results of the study have been published in Immunity by Cell Press, contributing to the international recognition of the scientific relevance of the work and providing the foundation for the translational development pathway of the platform.
Following this publication, Cristiana Vignoli, Chief Executive Officer of Hemera, was interviewed by Rassegna Business, an economic and scientific news outlet, to discuss the company’s strategic vision and the current stage of development of the REMaST as it progresses toward clinical translation.
Strategic vision of the REMaST platform
During the interview, Cristiana Vignoli outlined the strategic positioning of REMaST and the development roadmap required for its clinical translation.
“Our goal is to transform robust preclinical evidence into a structured and scalable clinical pathway capable of generating tangible value for patients and for the healthcare system,” says Cristiana Vignoli.
The interview highlights how the value of the technology integrates scientific, industrial, and regulatory dimensions, which are essential to support the transition from research to clinical practice.
From research to technology: the role of macrophages in regeneration
The REMaST therapeutic platform (Regenerative Educated Macrophages Self Transplantation) is based on the functional reprogramming of macrophages to activate biological processes involved in nervous tissue regeneration, including modulation of inflammation, support for neuronal survival, and promotion of axonal regeneration.
In preclinical models, the technology has demonstrated signs of functional recovery and remodeling of injured tissue, strengthening the rationale for further clinical translation.
“These results indicate that the immune system, when properly modulated, can become an ally in the regenerative processes of the central nervous system,” says Vignoli. “This represents a paradigm shift with significant implications for the development of cell therapies.”
An integrated pathway toward the clinic
The transition from preclinical research to first-in-human studies represents a key stage in the development of advanced therapies. Hemera is structuring this pathway through an integrated approach combining early interaction with regulatory authorities, leveraging the Orphan Drug Designation status and ATMP classification obtained, clinical development in internationally specialized neurosurgery and neurorehabilitation centers, and the industrialization of the manufacturing process under GMP conditions, with the aim of ensuring scalability, reproducibility, and product quality. This model enables an accelerated transition toward clinical stages, narrowing the gap between scientific research and therapeutic application.
A platform with expandable potential
REMaST is a regenerative medicine therapeutic platform initially developed for spinal cord injuries, with potential applications extending to other central nervous system disorders, including ischemic stroke and traumatic brain injury. The approach underlying the technology is part of a broader research framework aimed at understanding and modulating the role of the immune system in nervous tissue repair, with particular focus on macrophage functional plasticity.
In this context, REMaST fits into an emerging trajectory in regenerative medicine in which the immune system is explored not only as a mediator of inflammatory responses, but also as a potential active player in central nervous system regeneration processes, opening new perspectives for the development of advanced cell therapies.