Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Avascular Necrosis of the Femoral Head

Study Overview
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Brief Summary
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The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with avascular necrosis of the femoral head.

Official Title
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Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Avascular Necrosis of the Femoral Head

Conditions
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Avascular Necrosis of the Femoral Head

Intervention / Treatment
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* Procedure: Autologous Adipose Tissue derived MSCs Transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age :18-70, males and females. Subjects who understand and sign the consent form for this study. Clinical diagnosis of nontraumatic avascular necrosis of the femoral head Steinberg stage I, II, ⅢA Patients whose lesion is more than 30% (by Kim's Method) Exclusion Criteria: Patients who have collapsed femoral head Patient has had a Core Decompression or Multiple Drilling in the affected hip Patients who received osteoporosis medicines and parathyroid hormone drugs Taking medications that use the immunosuppressive drugs and cytotoxic agents or unable to discontinue their use for the duration of the study Taking medications that use the adrenocortical hormone drugs or unable to discontinue their use for the duration of the study Subject unable to undergo MRI (i.e. patients with pace-maker, metallic hip prosthetic implants) Women who are pregnant or breast feeding or planning to become pregnant during the study. Positive serology for HIV and hepatitis Serious pre-existing medical conditions like Cardiovascular Diseases, Cancer, Renal Diseases, Endocrine Diseases and Autoimmune Diseases Participation in another clinical trial or treatment with a different investigational product within 3 months prior to inclusion in the study. Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous Adipose Tissue Derived MSCs<br> | Procedure: Autologous Adipose Tissue derived MSCs Transplantation<br>* Into the Femoral Head infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 1x10e8 cells/3mL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Magnetic Resonance Imaging | To evaluate the change of treated femoral head using Magnetic Resonance Imaging (MRI) at 24 months post injection of MSCs. | 96 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SPECT/CT | To evaluate the change of treated femoral head using SPEC/CT at 24 months post injection of MSCs. | 96 weeks | 
| Hip X-ray | To confirm the collapse of femoral head using Hip X-ray at 24 months post injection of MSCs. | 96 weeks | 
| HHS (Harris Hip Score) | To evaluate the change of treated femoral head using Harris Hip Score at 24 months post injection of MSCs. | 96 weeks | 
| WOMAC (Western Ontario and McMaster Universities) Index | To evaluate the change of treated femoral head using WOMAC Index at 24 months post injection of MSCs. | 96 weeks | 
| UCLA (University of California Los Angeles) hip questionnaire | To evaluate the change of treated femoral head using UCLA hip questionnaire at 24 months post injection of MSCs. | 96 weeks | 
| Safety evaluation | To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using physical examinations, vital signs, treatment emergent adverse events (TEAEs), and the results of clinical lab tests. | 96 weeks |