Humans realized the capabilities and effects of medicinal intervention long before the term ‘Regenerative Medicine’ was coined. The evolution of medicine started with small but significant discoveries and techniques that still have an impact on the field today. Practises such as cleaning and debridement of wounds using vegetable and mineral combinations were commonplace then and are still used today as home remedies.
Regenerative medicine has come a long way since then, with modern scientists and research foundations zeroing more on cell and gene therapy, realizing its exponential potential in regeneration. One such name in the regenerative medicine space, which is entirely devoted to the development, manufacturing, registration, and distribution of Advanced Therapies Medicinal Products (ATMPs) based on cultures of epithelial stem cells, both for cell and gene therapy is Holostem Terapie Avanzate.
In the following interview, Marco Dieci, the CEO of Holostem, talks in detail about the revolutionary contribution of the firm to medicine since its inception.
Please brief our audience about your company, its USPs, and the aspects that make it a leading name in the regenerative medicine space.
Holostem Terapie Avanzate is a university spin-off founded in 2008 through the profitable union among Michele De Luca and Graziella Pellegrini, the University of Modena and Reggio Emilia and Chiesi Farmaceutici S.p.A. We have a highly experienced management team with sound know-how derived from a long tenure both in business administration and in academic research, successfully applied for many years in translational medicine.
Holostem is the first biotechnological company entirely devoted to the development, manufacture, registration, and distribution of Advanced Therapies Medicinal Products (ATMPs) based on cultures of epithelial stem cells both for cell and gene therapy. Our main aim is to promote epithelial stem cell-based regenerative medicine for patients with no alternative therapeutic solutions.
Michele De Luca and Graziella Pellegrini are internationally recognized as leading scientists in the field of epithelial stem cell biology aimed at clinical application in Regenerative Medicine and played a pivotal role in epithelial stem cell-mediated cell and gene therapy.
Besides their pioneering work on the use of human epidermal stem cell cultures in the life-saving treatment of massive full-thickness burns and in repigmentation of stable vitiligo and piebaldism, they were first in permanently regenerating a functional urethral epithelium – by means of cultured urethral stem cells – in patients suffering from posterior hypospadias and an oral epithelium – by means of cultured oral mucosa stem cells – in patients with defects of the gingival epithelium.
They were first in establishing human autologous limbal stem cell culture aimed at corneal regeneration in patients with severe limbal stem cell deficiency due to massive thermic and chemical burn-dependent destruction of the cornea. This treatment led to the recovery of vision in hundreds of patients with poor or no alternative therapy.
Thanks to the high experience in the field and to a GMP facility authorized to manufacture ATMPs for commercial use and for clinical trials, the company focuses its research on three therapeutic areas: corneal burns, epidermolysis bullosa, and hypospadias.
It also has an ATMP currently on the market: Holoclar®, the first autologous stem cell-based drug approved in Europe in 2015. It is a tissue-engineered therapy indicated for moderate to severe limbal stem cell deficiency caused by eye burns from physical or chemical agents and capable of restoring the eyesight of patients with severe cornea damage.
What other solutions and services do you offer that gives you a leading edge over its competitors?
Ours ATMPs are not only products but also 360° services that we offer to our clinical partners. In fact, in addition to the manufacturing of our medicinal products, we offer dedicated training to medical staff who will apply the therapy. Moreover, we support each Physician being present with our Medical Service Team during every surgical phase and throughout the transplantation process and offer assistance both pre-and post-treatment.
Our staff’s deep and internationally recognized scientific background and the constant effort made in the research and development of our products represent an important strength of Holostem in the ATMps market.
What is your opinion on the impact of the current pandemic on the global healthcare sector, and what challenges did you face during the pandemic and subsequent lockdowns?
The COVID-19 pandemic has had a major impact in our field as well. Specifically, we have had to stop treatments with Holoclar because all non-essential surgical procedures have been suspended to provide the care necessary to deal with the virus. Obviously, all healthcare facilities have been reorganized to prioritize the emergency. In mid-2021, activities finally resumed, and so far, they seem to be going well, although still sporadically. Although the latest data on new pandemic waves in Europe, we hope that in the coming months, it will be better.
With constant development in medical technologies, in your opinion, what could be the future of the regenerative medicine space?
We expect technology to streamline the manufacturing processes behind ATMPs, which are currently still labor-intensive. In addition, recent advances examples include achievements in stem cells knowledge, developments in the fields of cell and gene therapies, new vectors, nanoparticle technology, minimally invasive surgical tools, new biomaterials, research in silico for studying proteins or developing new drugs, and more.
Thanks to all these new technologies, regenerative medicine will carve out an increasingly large slice of standard medical practice, and the goal is to address more and more unmet needs. In order to achieve this goal, some issues closely related to the use of advanced therapies must be addressed, first of all, the market access through different national health systems.
As an established leader, what would be your advice to the budding professionals aspiring to venture into the biotech industry?
I will answer taking inspiration from the words of Steve Jobs: “stay hungry, stay foolish,” changing them in the following: stay foolish for science and use this to be a game-changer in life treating people.
In the biotech sector, where new knowledge runs fast and technology pushes, even more, it is essential to remain curious, have passion for what you do, be ambitious, and be always ready to get involved to learn and challenge yourself.
How do you envision scaling your company’s operations and offerings in 2021?
The year 2021 was marked by COVID-19, but also by Brexit, which affected our work in the UK. Despite the pandemic, we were able to activate new centers and continue commercial activities to treat a higher number of patients in Italy and in Europe.
The goals for the near future are to bring our product to the UK, increase further the number of clinical centers where patients can undergo treatment with Holoclar, and increase the number of countries in which we operate, which currently stands at 8 (Italy, UK, Germany, Austria, Belgium, Netherlands, Denmark, and the Czech Republic). Lots of people can be cured with Holoclar, but they still don’t know this. Our mission is to inform them and let them cure.
Share with us the awards and recognitions that you have received so far since inception.
Over the years, we have received several awards and recognitions. The most noteworthy are:
- Prix Galien Netherlands 2016 for Holoclar
- Prix Galien UK 2016 for Holoclar
- Award for innovation 2018 – ISSCR (Michele De Luca & Graziella Pellegrini)
- Black Pearl Award – Scientific Award EURORDIS 2018 (Michele De Luca & Tobias Hirsch)
- International Prize “Lombardia è ricerca” 2019 (Michele De Luca, Graziella Pellegrini & Tobias Hirsch)
- Louis-Jeantet Prize 2020 (Michele De Luca & Graziella Pellegrini)
- European Tech Women Award 2020 (Graziella Pellegrini)
- ERC Advanced Grant 2021 (Michele De Luca)
Our researchers were also received by the president of the Italian Republic, Sergio Mattarella, in 2018.
About the Leader
Marco Dieci began his career at Chiesi Pharmaceuticals, also collaborating in R&D of surfactant indicated in the prevention and treatment of prevention and treatment of respiratory distress syndrome in premature infants. He then spent over a decade as Director Industrial Operations at MolMed, following GMP development, both of all proprietary projects and those carried out for external customers. His last professional commitment was the design, implementation, and start-up of the Pharmaceutical Workshop of Ospedale Pediatrico Bambino Gesù in Rome. He has been managing Holostem since 2018.