Therapeutic outcomes of transplanting autologous granulocyte colony-stimulating factor-mobilised peripheral mononuclear cells in diabetic patients with critical limb ischaemia.

The efficacy and safety of transplanting autologous mesenchymal stem cells (MSCs), from granulocyte-colony-stimulating factor (G-CSF)-mobilised peripheral blood, was investigated in diabetic patients with critical limb ischaemia (CLI). After 3 months, the transplanted group of patients (n=7) showed a significant improvement in ischaemia manifestations, including pain and neurological signs, wound healing and the rate of lower-limb amputation, compared to the control group of patients (n=14). Pain was significantly reduced in the transplanted group compared to controls (P=0.014). The ankle-brachial index (ABI) and the pulse strength within ischaemic tissues of the transplanted group were significantly improved (P=0.035 and P=0.01, respectively). Importantly, 50% of the control group (7/14 patients) faced major amputation of a limb at the study's conclusion, compared to none of 7 patients in the transplanted group (P=0.047). The safety of transplantation was confirmed by observing no adverse reactions among the transplanted group, including infection and immunological rejection. Hence, this study provides further evidence that transplantation of autologous peripheral blood MSCs, mobilised by G-CSF, induces angiogenesis and improves the wound healing process in diabetic patients with CLI.

Growth hormone antibodies formation in patients treated with recombinant human growth hormone.

Human growth hormone (hGH) is normally produced by acidophilic cells of the anterior lobe of the pituitary gland. Recombinant DNA technology has made it possible to produce rhGH. There have been reports of immunological reactions in patients treated with rhGH. For this reason, it is necessary to check sera of patients for presence of antibody against rhGH. Forty-seven children were treated for up to 6 months with recombinant human growth hormone (rhGH-Novo), 0.1 IU/Kg body weight, subcutaneously, three times weekly. The magnitude of growth response was similar to those expected from clinical experience with pituitary growth hormone. We examined sera for specific antibodies against rhGH by ELISA methods. Four patients developed serum antibodies against growth hormone. The analysis of these four sera by Dot blotting method also showed presence of antibodies against rhGH. In the sera of treated patients, pre-incubated with different concentration of rhGH, specific antibodies were detected by neutralizing assay. This finding was confirmed by ELISA technique. In conclusion, the main concern with anti-GH antibodies could be their ability to neutralize circulating growth hormone and inhibition its growth promoting effect.