Translational stem cell research was begun at Cardiocentro Ticino in 2004, when the first transplant of bone marrow-derived stem cells was performed in the Lugano institute on a patient suffering from acute myocardial infarction (AMI). It was the first surgery of that kind in Switzerland, and one of the first in Europe in absolute terms.

The goal was to foster the regeneration of the infarcted tissue by implanting stem cells. The medical team that executed the transplant was led by Prof. Dr Tiziano Moccetti, while the cells were prepared by the Molecular Diagnostics Laboratory (LDM-Laboratorio di diagnostica molecolare).

Since that very first surgery in 2004, the international statutory framework has undergone significant changes. If, until a few years ago, cell manipulation could be performed in simple laboratories, the most recent directives issued by the Swiss regulatory authorities (Swissmedic) and European ones (EMA) establish, for institutes intending to work with stem cells, mandatory compliance with very strict manipulation rules and inspections.

Since 2007 cell-derived products, equated with pharmacological treatments, must be developed in compliance with strict GMP standards, a quality system used by the pharmaceutical industry to guarantee product quality. Stem cell-based products must be processed in “Cell factories”, sophisticated laboratories equipped with a dedicated “clean room”: a sterile environment where the parameters of pressure and temperature, environmental purity and contamination risks are kept constantly under control.

Determined to pursue the development of its own innovative therapies based on stem cells, Istituto Cardiocentro Ticino therefore decided to set up a Cell Factory equipped with a Clean Room. Obtaining Swissmedic authorisation in 2008, it became the first centre in Switzerland specialising in the production and development of treatments based on stem cells. The work done by the Istituto Cardiocentro Ticino Cell Factory is supervised by an ad hoc “Cell Therapy Unit”, which produces and releases material for innovative treatments.

The team also monitors the quality of both production premises and cell processing procedures. Finally, a technical and engineering service ensures maintenance and qualification of the tools used, guaranteeing emergency service on a 24 h-basis in the event of malfunction.

Through the setting up of this infrastructure, Istituto Cardiocentro Ticino endowed itself with a “tool” that very few hospitals in the world possess, explicitly designed and realised to explore new horizons and contribute to the writing of a new, fascinating chapter in the great book of medicine.