The Effect of Human Adipose Tissue-derived MSCs in Romberg's Disease

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 progressive hemifacial atrophy.

Detailed Description
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Adipose derived mesenchymal stem cells (AdMSCs) represent an attractive and ethical cell source for stem cell therapy. With the recent demonstration of MSC homing properties, intramuscular aplications of MSCs to cell-damaged diseases have increased. In a human clinical trial, five patients who had suffered a progressive hemifacial atrophy( Romberg's disease) were intramuscular administered autologous hAdMSCs (1×10e7 cells/500ul) with autologous microlipoinjection one time.

Official Title
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Preliminary Investigation of the Effect of Human Adipose Tissue-derived Mesenchymal Stem Cell in Progressive Hemifacial Atrophy(Romberg's Disease)

Conditions
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Progressive Hemifacial Atrophy, Romberg's Disease

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: Subjects who understand and sign the consent form for this study. Age :18-75, males and females. Patients with symptom of hemifacial atrophy but not progress disease. Exclusion Criteria: Patients with currently progressive hemifacial atrophy. Women who are pregnant or breast feeding or planning to become pregnant during the study. Subjects who don't understand purpose and method for this study. Patients with psychical disorder or drug and alcohol addiction. Participation in another clinical trial or treatment with a different investigational product within 30 days prior to inclusion in the study. Serious pre-existing medical conditions like Cardiovascular Diseases, Renal Diseases, Liver Diseases, Endocrine Diseases, Cancer and Diabetes Mellitus. 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: 75 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
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Autologous Adipose Tissue derived MSCs Transplantation|Intramuscular infusion of Autologous Adipose Tissue derived MSCs with autologous microlipoinjection. Dose: 1x10e7 cells/500ul/lipoinjection 20ml|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The volume change of fatty layer | To evaluate the volume change of fatty layer using 3D camera. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical lab tests | To assess the expression change of growth factors after tissue biopsy. | 24 weeks | 
| Fat absorption rate | To estimate the fat absorption rate using 3D computerized tomography and 3D camera. | 24 weeks |