[Italian clinical trials on cardiac cell therapy: where we are and where are we going?]

In the last years translation from bench to bedside of findings regarding cardiac cell therapy is swinging between delays and accelerations. Based on experimental studies, clinical trials were started in 2001. To date in Europe more than 900 patients have been treated with cell transplantation or mobilization and new clinical trials are ongoing in many countries. Published data provide a limited idea of current Italian clinical research in this field. This investigation intends to report Italian clinical trials and projects using cell therapy in cardiology.

Italian Centers involved in cell therapy clinical studies have been detected exploring scientific bibliography and online search engine. Selected Centers have been classified by the origin of collected information: i) peer-reviewed journals; ii) abstract, poster or communications; iii) press or media. A questionnaire was used and face-to-face or telephonic interviews were performed to obtain further details where needed.

Among the 16 selected Centers, 5 published their experiences on peer-reviewed journals, 5 produced abstracts or communications for scientific meetings and 6 bring out their protocols through press or media. Usually Italian clinical trials are monocenter (11 monocenter studies, 2 multicenter) and enrol few patients (an average of about 10 patients treated in each study); 2 Centers are waiting for protocol approval by the Italian Institute of Health; in one case approval was not obtained by the Ethics Committee. Few centers found projects on their own preclinical studies.

The investigation on Italian clinical experiences with cardiac cell therapy demonstrates the limits of what has been produced so far. An Italian working group on cardiovascular regenerative therapies could represent a useful tool to improve national clinical research in this field.