Singapore, Nov 5, 2008: Melbourne based Mesoblast has commenced a phase I/II clinical trial in the US using the patented allogeneic, or "off-the-shelf", Mesenchymal Precursor Cells (MPCs) in up to 30 patients with haematologic malignancies undergoing bone marrow transplantation.

 

This follows clearance by the United States Food and Drug Administration (FDA) of an Investigational New Drug (IND) submission, and ethics approval by the Institutional Review Board (IRB) at the University of Texas M. D. Anderson Cancer Center in Houston.  The trial will be funded through a grant awarded by the United States National Institutes of Health (NIH). 

 

The clinical trial will evaluate the safety and effectiveness of the proprietary MPCs to increase the rate and speed of bone marrow engraftment following transplantation of haematopoietic stem and progenitor cells. The trial's Principal Investigator is Prof Elizabeth J. Shpall, Director of the Cord Blood Bank and Medical Director, GMP Cellular Therapy Laboratory in the Department of Stem Cell Transplantation and Cellular Therapy.

 

The MPC product used in this trial will be developed under the FDA orphan drug designation recently granted to Mesoblast's United States-based sister company Angioblast Systems Inc. for treating patients with haematologic malignancies requiring increased haematopoietic stem and progenitor cell production. 

 

For the past 10 years, Prof Shpall and her colleagues at the M.D. Anderson Cancer Center have been developing procedures for the ex vivo expansion of cord blood.  In a recent collaborative study with Angioblast, Prof Shpall showed that the proprietary allogeneic MPCs could be used to rapidly and significantly expand the number of haematopoietic progenitor cells present in cord blood.