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Mesoblast receives FDA clearance for Phase 3 bone marrow transplant using adult stem cells.

Mesoblast, Ltd, Melbourne, Australia, announced it been approved by the US Food and Drug Administration (FDA) to begin a Phase 3 clinical trial for bone marrow regeneration in patients with blood cancers. The Phase 3 trial will aim to reproduce the positive drug pilot trial results seen at the University of Texas MD Anderson Cancer Institute.

The company says the trial resulted in accelerated neutrophil and platelet recoveries, together with excellent 100-day patient survival and low GVHD rates in patients receiving partially mismatched hematopoietic cells from umbilical cord blood expanded by Mesoblast's proprietary allogeneic mesenchymal precursor cells (MPCs).

The off-the-shelf MPCs are being developed under an Orphan Drug Designation granted for the condition of insufficient hematopoietic stem cell production in patients with hematologic malignancies who have failed treatment with conventional chemotherapy. Such patients are in need of bone marrow transplantation using hematopoietic stem cells that are of either autologous or allogeneic origin. Mesoblast's MPCs may potentially be used for expansion of both autologous and allogeneic hematopoietic stem cells for subsequent transplantation.

The Phase 3 trial will be conducted across 50 centers in the US, Europe and Australia, and will enroll 240 patients with hematologic malignancies undergoing unrelated bone marrow transplantation using matched or partially mismatched umbilical cord blood. Patients will be randomized to receive either non-expanded cord blood or cord blood expanded by Mesoblast's MPCs and containing 40-fold higher numbers of hematopoietic cells. The primary endpoint is a shortened time to neutrophil and platelet recovery in the treatment group.

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Publication:Transplant News
Date:Aug 1, 2011
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