Follow-up Study of Chondrogen® Delivered by Intra-Articular Injection Following Meniscectomy
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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).
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria:
- Subject must have received an injection in Protocol No. 550
- Subject must have completed the 6-month and final 2-year visit in Protocol No. 550
- Subject must provide written informed consent for entry into the extension study
- Subject must provide authorization for use and disclosure of protected health information for entry into the extension study
Trial design
Primary purpose
Allocation
Interventional model
Masking
55 participants in 3 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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