Osteoarthritis Clinical Trial
Official title:
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
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
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.
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