The Study of Early Stage Osteonecrosis of Femoral Head With Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-ONFH)

The Study of Early Stage Osteonecrosis of Femoral Head With Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSC)

The purposes of the study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cells (hUC-MSC) in treating osteonecrosis of femoral head patients.

This is a randomized,double-blind, paralleled study. Patients will be divided into two groups of experiment and control. All of them will receive core decompression of the femoral head, while experimental group patient will transplant hUC-MSC in addition. Follow-up visit will occur on 1 month, 3 months, and 6 months after operation, and Harris Hip score was applied to evaluate the symptoms change.

Inclusion Criteria:

• Ficat classification is I, IIa, or IIb period
• no obvious improvement or ingravescence by conservative treatment
• patients or their statutory receive human umbilical cord mesenchymal stem cell of their own will, and signed informed consent form

Exclusion Criteria:

• Ficat classification is third or fourth period
• acute, chronic infection patients
• combined with heart, lung, kidney disease, and cannot tolerate operation
• ankylosing spondylitis patient
• acetabular dysplasia patient
• with tumor
• clinical data deficient
• HIV positive
• pregnancy or breast feeding women
• under other therapy that possibly influence MSC security or efficacy