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news.Mesoblast, a manufacturer of biologic products for regenerative medicine, has reached a manufacturing agreement with the US Food and Drug Administration (FDA) for supply of its proprietary mesenchymal precursor cells (MPC) for Phase 3 clinical trials.
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The FDA acceptance was based on the comparability data of Mesoblast’s initial set of manufacturing runs for clinical product to be used in the upcoming Phase 3 trial for congestive heart failure.
Based on the characterization and testing of Mesoblast’s MPC technology, the FDA has approved the supply of MPC in Phase 3 clinical trails.
In addition, the company has provided the FDA with proposed assays to demonstrate potency for its MPC product and comparability studies to support manufacturing optimizations.
The patented MPC technology, in addition to cardiovascular disorders, is being developed for inflammatory and immunologic conditions, diabetes and its complications, orthopedic spine conditions, and cardiovascular disorders.