Clinical Trial: Ixmyelocel-T Treatment of Patients With Osteonecrosis of the Femoral Head

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Multi-center Clinical Trial of the Application of Ixmyelocel-T in the Treatment of Osteonecrosis of the Femoral Head

Brief Summary: The purpose of this study is to determine if Ixmyelocel-T grafting with demineralized bone matrix bound in autologous plasma after core decompression surgery is superior to core decompression with demineralized bone matrix bound in autologous plasma in preventing progression of osteonecrosis to a more severe disease stage (Stage II to III or higher) from the time of surgery until 24 months later, in patients with University of Pennsylvania (UPenn) Stage IIB or C disease at diagnosis.

Detailed Summary:

This study is an event-driven, multi-center, prospective, independent observer-blinded, controlled, randomized Phase III clinical trial enrolling patients diagnosed with University of Pennsylvania (Steinberg) Classification Stage IIB or C osteonecrosis of the femoral head.

  • The first patient group is the Treatment Group and will receive core decompression and treatment with BRCs and demineralized bone matrix bound in autologous plasma, and
  • The second patient group is the Control Group and will receive core decompression and demineralized bone matrix bound in autologous plasma, without any BRCs.
  • Enrollment: With an anticipated drop-out rate of 10% in up to twenty (20) sites, a total of approximately 135 patients will be enrolled and randomized to obtain 120 evaluable patients (75 for the TRC treatment group and 45 for the Control treatment group).
  • Primary endpoint: The percentage of patients progressing to a more severe UPenn disease stage (Stage II to III or higher) between 0 and 24 months will be the primary efficacy variable to demonstrate TRC therapy is superior to Control therapy.

Sponsor: Vericel Corporation

Current Primary Outcome: The progression of patients with UPenn Stage IIB or IIC disease to a more severe stage based on all available x-ray and MRI imaging. Patients who have a definitive procedure but do not have a valid assessment will be considered to have progressed. [ Time Frame: 24 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Time to progression (in months) [ Time Frame: 24 months ]
  • Osteonecrosis volume measured by MRI [ Time Frame: 24 months ]
  • Pain and quality of life questionnaires [ Time Frame: 24 months ]


Original Secondary Outcome: Time to progression (in months); osteonecrosis volume measured by MRI; pain and quality of life questionnaires [ Time Frame: 24 months ]

Information By: Vericel Corporation

Dates:
Date Received: July 20, 2007
Date Started: September 2007
Date Completion:
Last Updated: November 2, 2016
Last Verified: November 2016