CompletedPhase 1ACTRN12609001018202

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.


Sponsor

Mesoblast Ltd

Enrollment

24 participants

Start Date

Mar 19, 2009

Study Type

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

Sex: Both males and femalesMin Age: 18 YearssMax Age: 40 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether injecting stem cells combined with a lubricating gel into the knee after ACL reconstruction surgery can improve healing compared to the gel alone. Adults aged 18 to 40 who have had ACL reconstruction using their own hamstring tendon within 6 months of injury may be eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

A single injection of Mesenchymal Precursor Cells MSB-CAR001, of 75 million dose mixed with 2ml Hyaluronan and injected into knee


Locations(1)

Australia

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ACTRN12609001018202