And so an operation that had been publicly presented as a relaunch that had already taken place has failed. The Holostem case

On 7 July 2026, Holostem’s general meeting of shareholders resolved to wind up the company. The decision comes less than nine months after an interview in which the new management described 2025 as the year of rebirth: the company back in operation, the workforce back up to 55 people, Holoclar production restarted, European clinical collaborations, process automation, a multi-year plan and six new advanced therapy products to be developed as part of the IPCEI project. The chief executive concluded that Holostem possessed “the know-how, the people and the vision” to become the “Made in Italy of regenerative medicine”. Today, the reality, as certified by the ministries themselves, is quite different. The approach taken by the previous management of the Enea Tech and Biomedical Foundation, which owned 100 per cent of Holostem, would not have created the conditions necessary for a stable turnaround, despite the public funds invested and attempts to find industrial and financial partners. For this reason, the Ministry did not authorise the requested additional injection of liquidity and the company was once again placed into liquidation.

We are therefore not facing a sudden financial setback. We are facing the failure – at least in the form pursued thus far – of an operation publicly presented as a relaunch that had already taken place. The most serious contradiction concerns research. Holostem was not founded as an industrial entity to which a commercial plan could be applied from the outside. It was the vehicle through which the research developed over decades by Michele De Luca, Graziella Pellegrini and their team was transformed into clinical trials and therapies. Holoclar, the gene therapy for epidermolysis bullosa, and the epithelial stem cell platforms were not interchangeable products, separable from the people who had laid their biological, clinical and technological foundations. Yet, by the end of 2025, trials for epidermolysis bullosa had been at a standstill for two years, production of Holoclar was described as virtually halted, and the researchers who had developed those therapies were no longer involved in the scientific processes.

At that point, the question was already inevitable: who was actually leading Holostem’s research?

A company may replace a managing director, reorganise its management control functions or engage new financial advisers. It is far more difficult to replace the team that conceived the projects, who understand the biology of the cells used, the history of the production processes, the experimental failures, the clinical constraints and the reasons behind individual technological choices. To remove or exclude that team and continue to speak of scientific continuity would have reduced Holostem to a ghost ship: the hull still painted with its glorious name, the laboratories lit up, the sails billowing with press releases and the course charted in the business plans, but the bridge deserted. Those who knew the sea, who had built the ship and knew where to steer it, had been left ashore; on board remained nautical charts full of promises, whilst no one was at the helm – merely someone on shore recounting tales of fantastical voyages. The issue is not whether a company should be run by scientists rather than managers. The issue is understanding what business plan could possibly be credible after separating the production structure from the scientific expertise that had generated its key products. The celebratory press release of October 2025 spoke of a complete ‘core team’, new delivery systems, six therapies to be developed and a capability ranging from research to GMP production. A few weeks later, it emerged publicly that the clinical programmes had stalled and that the developers of the therapies had been sidelined. The following July, the company was wound up. 

There is also an issue that requires accounting answers, not further announcements. Holostem had been selected for the IPCEI Med4Cure programme with a project entitled “Integrated Platform for Cellular and Gene Therapy”, aimed, according to the company, at developing six products for rare diseases. As recently as 3 July 2026, the Emilia-Romagna Region noted that Holostem was one of five Italian companies receiving European research funding. It is therefore necessary to disclose, on a project-by-project basis, the amount of resources allocated or earmarked, the sums actually received, the costs incurred, the experimental activities carried out, the milestones achieved, and what will now become of the funding, equipment, data and intellectual property. If the financial statements show grants, receivables or revenue linked to research projects, it must be explained what work these correspond to and who actually carried out those activities, whilst the main experiments were at a standstill and the original researchers had been excluded.

It is incorrect to claim, without accounting documents, that the money has disappeared. It is, however, entirely legitimate to ask where it was spent, with what verifiable results and under whose responsibility. All the more so because Holostem is owned by a public foundation, overseen by the Ministry of Enterprise and the Ministry of Health, and because the Government itself admits that the relaunch has failed despite the public funds already invested. The Ministry now promises that the ‘Holostem project’ will continue within a broader national platform for regenerative medicine. This is a formula that bears too close a resemblance to those already used to announce the company’s revival. Before presenting another plan, data on the previous one is required: money invested, activities carried out, therapies actually produced, trials initiated, relationships with researchers, European obligations and the reasons for the latest liquidation. Holostem’s science is not the same as its brand, its pharmaceutical operations or its corporate presentations. It consisted of knowledge, people and specific experimental programmes. Those who claimed to have saved the company by ousting or marginalising those who had generated that science must now explain what they thought they had saved.