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

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.

• Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) (Drug): Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) will be injected through surgery tunnel, 2*10\^7 cells,
• core decompression (Procedure): The surgery will drill into the femoral neck (hip bone) and through the necrotic area of the bone that died from the lack of blood flow, take out partial osseous tissue.

Primary outcomes

• MRI imageological examination [6 months]: MRI imageological examination to evaluate the efficient of mesenchymal stem cells.

Secondary outcomes

• Harris Hip Score [6 months]: Evaluate curative effects by the change of Harris hip score.

Sex: All

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

• Bahushan, Study director, Inner Mongolia International Mongolian Hospital
• Lei Guo, Dr., Study chair, China-Japan Union Hospital, Jilin University