NCT00001398

Stem Cell Factor Medication for Aplastic Anemia

A Phase I/II Trial of Recombinant Methionyl Human Stem Cell Factor (r-metHuSCF) in Patients Diagnosed With Acquired Aplastic Anemia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (planned)
• Sponsor: National Heart, Lung, and Blood Institute (NHLBI) · NIH
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This trial, sponsored by Amgen, Inc., which produces the recombinant methionyl human stem cell factor (r-metHuSCF), also involves two other institutions. The primary objective is determination of the safety of administering multiple doses of r-metHuSCF in the setting of acquired aplastic anemia and evaluation of the effect of r-metHuSCF on peripheral blood counts. Potential effects of r-metHuSCF on frequency of need for red cell or platelet transfusions and on bone marrow morphology/cellularity will also be evaluated.

Detailed description

This trial, sponsored by Amgen, Inc., which produces the recombinant methionyl human stem cell factor (r-metHuSCF), also involves two other institutions. The primary objective is determination of the safety of administering multiple doses of r-metHuSCF in the setting of acquired aplastic anemia and evaluation of the effect of r-metHuSCF on peripheral blood counts. Potential effects of r-metHuSCF on frequency of need for red cell or platelet transfusions and on bone marrow morphology/cellularity will also be evaluated.

Conditions

• Aplastic Anemia
• Pancytopenia

Interventions

Type	Name	Description
DRUG	Recombinant Methionyl Human Stem Cell Factor (r-metHuSCF)

Timeline

• Start date: 1993-10-01
• Completion: 2002-06-01
• First posted: 1999-11-04
• Last updated: 2008-03-04

Locations

1 site across 1 country: United States