Phase I and early phase II studies on human urinary colony stimulating factor.

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