Phase 2 Study to Assess 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 Undergone an ACL Reconstruction

NCT01088191 Phase 1/Phase 2 COMPLETED

The purpose of this study is to evaluate safety and preliminary efficacy of MSB-CAR001 in subjects who have recently undergone an Anterior Cruciate Ligament Reconstruction

Details

Lead sponsor	Mesoblast, Ltd.
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	17
Start date	2009-03
Completion	2014-10

Conditions

• Anterior Cruciate Ligament Injury
• Osteoarthritis

Interventions

• MSB-CAR001 Combined With Hyaluronan
• Hyaluronan

Primary outcomes

• To determine the overall safety of MSB-CAR001 plus carrier using physical examinations, vital signs, treatment emergent adverse events (TEAEs), and the results of clinical lab tests (hematology, serum chemistry, inflammation, and immunology). — 2 years

Countries

Australia