A randomised, double-blind, comparator study to assess the safety & tolerability of a single injection into the knee joint of MSB-CAR001 when combined with Hyaluronan compared to Hyaluronan alone in patients who have recently undergone an Anterior Cruciate Ligament Reconstruction.
A randomised, double-blind, comparator study to assess the safety & tolerability of a single injection into the knee joint of two different doses of MSB-CAR001 combined with Hyaluronan compared to Hyaluronan alone in patients who have recently undergone an Anterior Cruciate Ligament Reconstruction.
Mesoblast Ltd
24 participants
Mar 19, 2009
Interventional
Conditions
Summary
This study is primarily designed to assess the safety of two different doses of allogeneic Mesenchymal Precursor Cells (MPCs) combined with Hyaluronan when injected into the knee joint following Anterior Cruciate Ligament reconstruction. Long term safety, tolerability and efficacy of a single injection of two different doses of allogeneic MPCs + Hyaluronan compared to Hyaluronan alone will be assessed at 6, 12 and 24 months following MPC injection. This study aims to provide prelimanary data to support dose selection for future studies.
Eligibility
Plain Language Summary
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Interventions
A single injection of Mesenchymal Precursor Cells MSB-CAR001, of 75 million dose mixed with 2ml Hyaluronan and injected into knee
Locations(1)
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ACTRN12609001018202