Hematologic Malignancies Clinical Trial
Official title:
A Phase 1 Trial of a Single ProHema® CB Product (Ex Vivo Modulated Human Cord Blood Cells) Following Myeloablative Conditioning for Pediatric Patients With Hematologic Malignancies
This is an open-label, safety study of a single ProHema-CB product administered following myeloablative conditioning regimen in pediatric subjects with hematologic malignancies.
A maximum of 18 eligible male and female subjects (1 to 18 years old, inclusive) will be
enrolled and treated in the trial at approximately 3 to 5 centers within the U.S. These 18
subjects will consist of 3 cohorts of 6 subjects each. The cohorts will be defined by age: 1
to 4 years; > 4 to 12 years; and > 12 to 18 years. These cohorts will be enrolled
simultaneously.
All subjects will be admitted to the hospital, per institutional practice, and will receive a
myeloablative conditioning regimen, after which they will receive an HLA-matched or partially
matched ProHema-CB unit on study Day 0.
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