Two clinical studies have been carried out to first check the safety and then the effectiveness of integration with the stem differentiation factors of standard chemotherapy treatments. A first study was conducted on 200 patients, including 60 with advanced breast cancer, to evaluate possible side effects: for this reason no control group was foreseen. The protocol included administering patients 1 ml 3 times a day as sublingual drops containing 3 microgram / ml staminal differentiation factors.
After 3 years of treatment, no adverse events were reported in any of the 200 patients treated; In addition, 80% of these patients showed an improvement in the performance status, evaluated with the E.C.O.G scale: generally, the status status shifted from a 4 to 3 state to one of 2 or 1. In the 60 breast cancer patients there were also 4 cases of partial regression and 70% of survival after 3 years.
Biava, P.M .; Bonsignorio, D .; Impagliazzo, M .; Frosi, A .; Larese, F .; Negro, C .; Hermann, G.F.; Matarese, S .; Malzac, J .; Pontiggia, P., & lt; / RTI & gt; Embryonic differentiation factors with anti-cancer properties: preliminary clinical results in the therapy for advanced tumors. J. Tumor Marker Oncol., 2002, 17 (3), 65-69
A randomized clinical trial was performed on 179 patients with intermediate or advanced hepatocarcinoma. The results showed a statistically significant difference between the group treated with the synergy of differentiation factors and standard treatments and the control group (P = 0.03), a difference in favor of the group treated with integration. There were 19.8% of regression (2.5% of which total regression) and 16% of disease stabilization. Livraghi, T .; Meloni, F .; Frosi, A .; Lazzaroni, S .; Bizzarri, M .; Frati, L.; Biava, P.M. Treatment with stem cell differentiation stage factors of intermediate-advanced hepatocellular carcinoma: an open randomized clinical trial. Oncol. Res., 2005, 15, 399-408