Clinical application of partially purified human urinary colony-stimulating factor

Human urinary colony-stimulating factor (CSF-HU) has been partially purified using five purification procedures (preparation II) for clinical use. In phase I study, six healthy volunteers were injected with preparation II of CSF-HU by a single intravenous droplet infusion. Two volunteers received 4 X 10(6) units (U), two received 8 X 10(6) U, and the final two received 1.2 X 10(7) U of preparation II of CSF-HU. Five volunteers did not have any symptoms, but one volunteer who received 1.2 X 10(7) U complained of transient, mild chilliness during the infusion. Liver function test, coagulation test, urine analysis and patterns of electrocardiogram did not change after infusions. In phase II study on preparation II of CSF-HU, forty-four patients with urological malignancy were infused with a daily dose of 8 X 10(6) U CSF-HU for 7 days from the next day after the end of the second courses of two consecutive courses of the same chemotherapeutic regimen. The average nadirs of leukocytes and granulocytes of 33 evaluable cases were higher in CSF-HU-infused courses (second courses) than in control courses (first courses), with statistic significances. The average period under 2,000 leukocytes/mm3 and the average period under 500 granulocytes/mm3 were shorter in CSF-HU-infused courses than in control courses. These results might indicate that infusions of preparation II partially protect the patients from granulocytopenia after anticancer chemotherapies.