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A Pilot Trial of Unrelated Umbilical Cord Blood Transplantation Augmented With Ex Vivo CytokinePrimed ALDHbr Umbilical Cord Blood Cells
The main purpose of this investigational (not approved by the FDA) Phase I research is to test whether transplantation of umbilical cord blood cells can be safely supplemented with a transfusion of a portion of these cells that have been sorted (collected from a special machine called a cell sorter) and then either infused a few hours after the standard transplant or for some patients grown in a special system in the laboratory prior to the transplant, designed to increase the number of stem cells transplanted. This system is currently in the early phases of testing.
Details
| Lead sponsor | Joanne Kurtzberg, MD |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 37 |
| Start date | 2005-10 |
| Completion | 2012-07 |
Conditions
- MDS
- Anemia, Aplastic
- Inborn Errors of Metabolism
- Congenital Marrow Failure
- Congenital Immunodeficiency Syndrome
Interventions
- ALDHbr Umbilical Cord Blood Cells
Primary outcomes
- To assess the safety of infusing ex vivo cytokine-primed ALDHbr cells isolated from banked unrelated umbilical cord blood (CB) into patients also receiving a standard unmanipulated unrelated CB transplant delivering >2.5x10e7 nucleated cells per kg. — Prospective
Countries
United States