ABSTRACT
OBJECTIVES: This is a randomized trial adopted to evaluate the safety and efficacy of immunization with specific anti-hepatocellular carcinoma dendritic cells (DCs) in Egyptian patients with advanced hepatocellular carcinoma (HCC) as a treatment or adjuvant therapy in comparison with the traditional therapy. METHODS: This study was conducted on 20 HCC patients who were assigned to four groups according to BCLC staging; group I: HCC patients (stage B) received trans-arterial chemoembolization (TACE) and DCs as an adjuvant therapy; group II: HCC patients (stage B) received TACE only; group III: advanced HCC patients (stage D) received DCs vaccine; group IV: advanced HCC patients (stage D) received supportive treatment. DCs were generated from peripheral blood monocytes and pulsed with a lysate of an allogeneic hepatic cancer cell line (HepG2). Toxicity and immunological response were reported as primary outcomes whereas clinical biochemical and radiological responses were reported as secondary outcomes. RESULTS: Our study detected that patients who received DCs vaccine (group III) showed mild decrease in Child-Pugh score as well as AFP and PIVKA II levels and developed 20% partial response [PR] 40% stable disease [SD] and 40% progressive disease [PD] compared to the patients of group IV on supportive treatment who developed 100% PD. Although group I patients developed PR (60%) SD (20%) and PD (20%) no significant difference was detected in the clinical biochemical or radiological response between group I and group II patients. DCs vaccine had minimal adverse effects with no autoimmunity and elicited a better immunological response such as increased CD8 cells percentage and number as well as decreased TGFß levels in the vaccinated patients. CONCLUSION: DCs vaccine is safe as it is not associated with significant toxicity. However due to the small number of included patients the efficacy and immune response of using DCs vaccine in the treatment of advanced HCC patients need to be justified by testing of a large cohort.
ABSTRACT
BACKGROUND: Diabetic nephropathy (DN) is one of the most serious complications of diabetes worldwide. Strong evidence suggests that several growth factors may contribute to the initiation and progressive fibrosis of DN. Recently, there is an overexpression of platelet-derived growth factor (PDGF) in renal biopsies from patients with DN. This study aimed to investigate the clinical significance of urinary PDGF-BB level in type 2 diabetic patients with and without nephropathy and to evaluate its relationship with various clinical and laboratory parameters. METHODS: Urinary levels of PDGF-BB were measured in 60 Egyptian type 2 diabetic patients categorized into three equal groups (normo-, micro-, and macroalbuminuria), according to urinary albumin level. In addition, 20 healthy subjects were selected to serve as controls. RESULTS: The urinary PDGF-BB levels were significantly increased in type 2 diabetic patients as compared to controls (p < 0.001). Moreover, diabetics with micro- and macroalbuminuria had significantly higher levels than in those with normoalbuminuria (p < 0.001). Urinary PDGF-BB correlated positively with disease duration, low-density lipoprotein (LDL)-cholesterol, and urinary albumin and negatively with creatinine clearance in diabetic patients. In a multiple regression model, urinary PDGF-BB was strongly and independently associated with nephropathy in diabetic patients (ß = -0.03, p < 0.001). CONCLUSIONS: PDGF-BB may play an important role in the initiation and progression of DN. It is considered as a good predictor for early deterioration of renal function in DN. Thus, measurement of urinary PDGF-BB in type 2 diabetic patients could be used for early detection of diabetic renal disease.
