Clinical Trial: Mesenchymal Stem Cell for Osteonecrosis of the Femoral Head

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Mesenchymal Stem Cell Transplantation in the Treatment of Osteonecrosis of the Femoral Head

Brief Summary: Mesenchymal Stem Cells (MSCs) have been shown to have immunosuppressive and repairing properties. Bone marrow mononuclear cells (BMMNCs) have revascularization properties and complimentary effects to MSCs. The investigators will infuse expanded autologous MSCs and BMMNCs into patients with osteonecrosis of the femoral head. The study purpose is to examine whether this treatment will result in improvement in osteonecrosis of the femoral head.

Detailed Summary: Mesenchymal Stem Cells (MSCs) have been shown to have immunosuppressive and repairing properties. Bone marrow mononuclear cells (BMMNCs) have revascularization properties and complimentary effects to MSCs. Patients in this study will receive infusion of expanded autologous MSC and BMMNCs. The puncture of femoral artery will be conducted with digital subtraction angiography(DSA), and the tubes will be inserted into medial femoral circumflex artery,lateral femoral circumflex artery and obturatou artey. The study will evaluate the safety and effectiveness of MSC infusion in patients with osteonecrosis of the femoral head. This study will last for 5 years. Patients will undergo infusions at Day 0. Afterward, patients will be evaluated for response, and undergo X-ray examination, CT and MR scanning at a 6-month interval.
Sponsor: Jianming Tan

Current Primary Outcome: The femoral head blood-supply artery angiographies and the areas of femoral head necrosis [ Time Frame: 2 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Coxa joint paining [ Time Frame: 2 ]
  • Walking distance [ Time Frame: 2 ]
  • Joint functions [ Time Frame: 2 ]
  • Life [ Time Frame: 2 ]


Original Secondary Outcome: Same as current

Information By: Fuzhou General Hospital

Dates:
Date Received: December 21, 2008
Date Started: December 2009
Date Completion: August 2015
Last Updated: October 6, 2012
Last Verified: October 2012