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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Osteonecrosis of Femoral Head

Intervention / Treatment
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* Drug: Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)
* Procedure: core decompression


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Core decompression surgery; Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#). | Drug: Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)<br>* Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) will be injected through surgery tunnel, 2*10^7 cells,<br>Procedure: core decompression<br>* 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.<br>|
| Placebo Comparator: Group 2<br>Core decompression surgery. | Procedure: core decompression<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI imageological examination | MRI imageological examination to evaluate the efficient of mesenchymal stem cells. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score | Evaluate curative effects by the change of Harris hip score. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteonecrosis of Femoral Head, umbilical cord mesenchymal stem cells