Mesoblast ACDF Clinical Trial

Title: “A Prospective, Multicenter, Randomized, Single-Blinded, Controlled Study Evaluating Safety and Preliminary Efficacy of NeoFuse™ when Combined with MasterGraft™ Matrix in Subjects Undergoing Multi-Level Anterior Cervical Discectomy and Fusion with Anterior Cervical Plate Fixation”

Study Sponsor: Mesoblast, Ltd

Principal Investigator: Christopher Rumana, MD

Study Synopsis: To determine the safety and feasibility of interbody fusion with one exploratory dose of NeoFuse™ (allogeneic mesenchymal precursor cells), combined with MasterGraft™ Matrix as a carrier and radiolucent cervical cage for multi-level anterior cervical discectomy and fusion (ACDF) with anterior cervical plate fixation through 12 months follow-up.

Patients enrolled in the trial will be randomized to receive either 5 million MPCs of NeoFuse™ at each cervical fusion level (investigational group) or cervical Allograft Spacer (control group). All study subjects will undergo clinical evaluation during hospitalization for the surgical procedure and at 1 month, 3 months, 6 months, 12 months, and 24 months. This study will enroll a total of 24 patients and be conducted at 10 sites in the United States.

Study Status: Closed for enrollment.

For more information, contact Lutheria Hollis, CCRC, at (850) 877-5115.

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