This report demonstrates the first trial for the clinical application of human urinary colony stimulating factor (CSF
HU) which was highly purified and well characterized in our laboratory. In the Phase I study, 6 healthy volunteers were administered with 2.5×10
5 to 10
6 units of CSF
HU intravenously. CSF
HU did not show any severe side effects, although slight depression of maximum blood pressure was observed in the group injected with 10
6 units CSF
HU and one volunteer who received 5×10
5 units CSF
HU complained sweating and itching during the infusion. In the Phase II study, six cases suffering from lecukocytopenia induced by anticancer drugs or irradiation were treated with 7 day intravenous CSF
HU injections. Although recovery of leukocyte number was not observed in the group injected with 7×10
6 units CSF
HU, complete or partial recovery of leukocyte and granulocyte number was observed in the group injected with 1.3 to 1.4×10
7 units CSF
HU, Phase II study in a large scale is under way to evaluate further the effectiveness of CSF
HU on leukocytopenic patients.
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