NCT01088191

Safety and Efficacy Study of MSB-CAR001 in Subjects 6 Weeks Post an Anterior Cruciate Ligament Reconstruction

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Mesoblast, Ltd. · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is a prospective, single center, randomized, double blind, controlled Phase 1b/2a study designed to evaluate the safety and tolerability of a single injection into the knee joint of two different doses of MPCs combined with Hyaluronan compared to Hyaluronan alone in patients who have recently undergone an Anterior Cruciate Ligament Reconstruction. All subjects in this study have undergone unilateral ACL reconstruction surgery within six months of injury. MSB-CAR001 plus Hyaluronan at one of two doses or Hyaluronan alone will be injected into the knee joint. After the screening and injection visits, each subject will be evaluated clinically within 3 days and 28 days after surgery, and at 2, 3, 6, 9, 12, 18, and 24 months after surgery. The radiographical exams will be performed at 6, 12, 18, and 24 months after surgery. Subjects will be evaluated at 24 months after surgery for safety.

Conditions

• Anterior Cruciate Ligament Injury
• Osteoarthritis

Interventions

Type	Name	Description
BIOLOGICAL	MSB-CAR001 Combined With Hyaluronan	Knee Injection of Biological: MSB-CAR001 Combined With Hyaluronan Single Injection Into the Knee Joint of Single Doses of MSB-CAR001 Combined With Hyaluronan
DRUG	Hyaluronan	Hyaluronan alone

Timeline

• Start date: 2009-03-01
• Primary completion: 2013-11-01
• Completion: 2014-10-01
• First posted: 2010-03-17
• Last updated: 2018-08-15

Locations

1 site across 1 country: Australia