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Infusion of one MPC expanded cord unit and one unexpanded cord unit · 1 trial · 4 indications
| Arm | Type | Description |
|---|---|---|
| Active | EXPERIMENTAL | Infusion of one MPC expanded cord unit and one unexpanded cord unit. |
| Control | ACTIVE_COMPARATOR | Infusion of two unexpanded cord blood units. |
| Name | Type | Description |
|---|---|---|
| Infusion of one MPC expanded cord unit and one unexpanded cord unit | BIOLOGICAL | Infusion of one MPC expanded cord unit and one unexpanded cord unit. |
| Infusion of two unexpanded cord blood units. | BIOLOGICAL | Umbilical Cord Blood. |
Inclusion Criteria: * Patient must have one of the following: * Acute myelogenous leukemia (AML) in complete morphological remission at study screening (Complete Remission with Incomplete Platelet Recovery (CRp) acceptable). * Acute lymphoblastic leukemia (ALL) in complete morphological remiss...
It is an investigational cell therapy being developed by Mesoblast Limited for patients with hematologic malignancies, including acute myelogenous leukemia. The product combines one cord blood unit expanded with mesenchymal precursor cells (MPCs) and one unexpanded cord blood unit, given together as a single infusion to support blood cell recovery after transplantation.
It is being studied as a graft source for patients with acute myelogenous leukemia who are undergoing cord blood transplantation. The expanded plus unexpanded cord unit combination is intended to provide donor cells for hematopoietic reconstitution in patients with hematologic malignancies, including acute myelogenous leukemia, acute lymphoblastic leukemia, non-Hodgkin's lymphoma, and Hodgkin's disease.
Mesoblast Limited, which trades under the ticker MESO, is the developer of the infusion of one MPC expanded cord unit and one unexpanded cord unit. The company is evaluating the product in cord blood transplantation for patients with hematologic malignancies.
The infusion of one MPC expanded cord unit and one unexpanded cord unit is in Phase 3 development. It is an investigational therapy and is not approved for commercial use. The Phase 3 study has been completed, and no trials of this product are currently listed as active.
The product has been studied in one completed Phase 3 trial, NCT01854567, titled a study of umbilical cord blood cells expanded with MPCs for transplantation in patients with hematologic malignancies. The trial enrolled 49 patients in the United States, was randomized, and used an active control design.
No. The completed Phase 3 trial, NCT01854567, was randomized and actively controlled but was not double blind. It enrolled 49 patients with hematologic malignancies, including acute myelogenous leukemia, and was conducted in the United States.