Università degli studi di Modena e Reggio Emilia

Centre for Regenerative Medicine: Holostem is now 10 years old

The university spin-off “Holostem Terapie Avanzate”, hosted at the “Stefano Ferrari” Centre for Regenerative Medicine (CRM) of Unimore, is now 10 years old, and this is the perfect opportunity to remember the extraordinary phases during which it was awarded several scientific and industrial prizes.

Holostem Advanced Therapies had been created in response to the new European regulation 1394/2007 that considered the advanced therapies (cell therapy, gene therapy, tissue engineering) equivalent to medicines, and is based on a virtuous match between the scientific skills of world-renowned researchers, like Michele De Luca and Graziella Pellegrini, the innovative spirit of the University of Modena and Reggio Emilia (Unimore) and the industrial expertise of Chiesi Farmaceutici S.p.A., indispensable to continue providing patients with the products of the research on epithelial stem cells.

“The cooperation between science and industry on one side, and public and private sector on the other, has always been so close to make the results achieved during these years by the various Holostem partners basically indistinguishable“, Paolo Chiesi - the President of Holostem and Deputy President of Chiesi Farmaceutici - explains.

“The sound scientific background, the extraordinary clinical results achieved and the international credibility of Michele De Luca and Graziella Pellegrini, together with the reliability of Unimore, have convinced us to invest in this state-of-the-art biotechnological reality that needed our pharmaceutical know-how to industrialise extremely innovative products developed by researchers”, the Holostem Deputy President and founder member Andrea Chiesi adds.

Thanks to Holostem regulatory competences, the GMP (Good Manufacturing Practice) certification was obtained in a really short time for the production of cell cultures for cell and gene therapy, at first only for clinical experimenting (2010) and afterwards for the commercial production all over the European territory (2014).

The first product approved in the world and certified for the quantity of stem cells injected was developed by Holostem. In 2015 it was given the marketing authorisation with the name of Holoclar Ò, and it is useful to renew the corneal epithelium after it has been damaged by thermal or chemical burns, allowing for the full recovery of visual capacity.

“The industrialisation of cultures and the regulatory procedure required for the approval have been a real challenge for researchers like us, who had never dealt before with all those aspects that - other than the scientific one - are indispensable to make the results of so many years of our research available to patients,” as the R&D Director of Holostem and Coordinator of Cell Therapy at CMR Graziella Pellegrini recalls.

A result of decades of research is also the gene therapy for Epidermolysis Bullosa (EB), one of the other products that Holostem is processing to bring it to the market. A few months ago, the entire world knew the story of little Hassan, a Syrian refugee suffering from Junctional EB who was in desperate conditions and was saved by genetically corrected cells produced in Modena in the pharmaceutical laboratory of CMR managed by Holostem. “The work of nearly the entire staff at Holostem, in collaboration with CMR researchers, allowed us to start clinical experiments on other forms of Epidermolysis Bullosa, like the Distrofic and the dependent COL17 Junctional forms” , the Scientific Director of Holostem and Director and Coordinator of CMR Gene Therapy Michele De Luca reports.

Marco Dieci, General Director of Holostem, adds that “EB is one of the development strategic objectives of the next years, together with other products for advanced therapies that we are developing, to fully complete the mission defined by Holostem 10 years ago to bring patients effective solutions for serious medical problems, where regenerative medicine is the only one or best therapy alternative, such to justify its use through ethic values and scientific excellence”.

“During all these years as the Rector of Unimore, I have had the opportunity to know better all the protagonists of this spin-off, that represents an extraordinary virtuous example for our University, and is an example of great collaboration between public and private entities”, Unimore Rector Angelo O. Andrisano concludes. “And I could only appreciate them more and more for the results achieved during these years, recognised by the international press and the several awards received, that have taken the name of the spin-off and of our University to all most advanced countries in world research, thus offering an employment opportunity to many our young researchers”.

Categorie: International - english