The objective of the present study is to establish the long-term safety of an intra-articular injection of human mesenchymal stem cells (hMSCs) (Chondrogen).
The long-term safety of human mesenchymal stem cells (hMSCs) (Chondrogen) has not yet been established. This 3-year follow-up study will provide additional data to gain understanding of the safety of the investigational agent. This study is designed to determine the safety of a single intra-articular injection of 50 million donor-derived hMSCs or 150 million donor-derived hMSCs in suspension with commercial sodium hyaluronan compared to an injection of vehicle (diluted hyaluronan) alone. The injections were performed under the initial study, Protocol No. 550.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
55
Intra-articular injection of ex vivo cultured adult human mesenchymal stem cells
Intra-articular injection of ex vivo cultured adult human mesenchymal stem cells
Intra-articular injection of Hyaluronan
University of Southern California Keck School of Medicine
Los Angeles, California, United States
OrthoIndy
Indianapolis, Indiana, United States
TRIA Orthopaedic Center
Bloomington, Minnesota, United States
Unlimited Research
San Antonio, Texas, United States
Comparison of treatment adverse event rates
Time frame: Through 3 years
Concomitant Medications
Time frame: Through 3 years
Visual Analog Scale
Time frame: Through 3 years
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