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news.Mesoblast, an Australian biotechnology company, has started a Phase I/II clinical trial in the US using the patented allogeneic, or 'off-the-shelf', mesenchymal precursor cells in up to 30 patients with hematologic malignancies undergoing bone marrow transplantation.
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This follows clearance by the FDA of an investigational new drug submission, and ethics approval by the Institutional Review Board at the University of Texas MD Anderson Cancer Center in Houston. The trial will be funded through a grant awarded by the US National Institutes of Health.
The clinical trial will evaluate the safety and effectiveness of the proprietary mesenchymal precursor cells (MPCs) to increase the rate and speed of bone marrow engraftment following transplantation of hematopoietic stem and progenitor cells.
The MPC product used in this trial will be developed under the FDA orphan drug designation recently granted to Mesoblast’s US-based sister company Angioblast Systems for treating patients with hematologic malignancies requiring increased hematopoietic stem and progenitor cell production.