Safety and efficacy of systemically administered autologous Gold-Induced Cytokines (GOLDIC®)

Abstract

Objective: GOLDIC® is a novel technology involving the in vitro pre-conditioning of autologous patient whole blood with gold particles to induce autologous protein production. This study aimed to evaluate the safety and efficacy of GOLDIC® induced cytokines by intravenous injection into patients with various systemic diseases (allergies, fibromyalgia, psoriasis, rheumatoid arthritis, ulcerative colitis, polymyalgia rheumatica, osteoporosis and other diseases). Patients and Methods: This is a prospective observational case series study of 55 patients suffering from various chronic systemic diseases who were treated with intravenous GOLDIC® injection. Inclusion criteria were having been diagnosed with a chronic systemic disease not efficiently controlled by the standard treatment. The mean age of participants was 55.9±18.4 years. Four consecutive intravenous GOLDIC® injections were carried out at 3 to 7 days intervals. The primary screening criterion was the treatment effectiveness documented by the Visual Analogue Scale (VAS) and global assessment. The initial findings were compared to the VAS values before the treatment and yearly over a period of at least 6 months and up to 6 years. Results: Eight different disease groups were treated with the intravenous GOLDIC® method. There were statistically significant improvements in VAS scores following GOLDIC® treatment. There were no treatment-related adverse events and serious adverse events. The most impressive results were seen in patients with allergies and fibromyalgia. Conclusions: GOLDIC® was confirmed as a novel method for conservative management of chronic systemic diseases. GOLDIC® produced a rapid and sustained improvement in symptomatology. This study is an open-label non-randomized, non-controlled study using a heterogeneous patient population. Future randomized-controlled trials may fully validate the safety and efficacy of GOLDIC® in different patient populations.

Keywords

• autologous gold-conditioned plasma
• chronic systemic disease
• gelsolin
• goldic®