The Clinical Application of Adipose-Derived Stem Cells on Facial Rejuvenation

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the adipose-derived stem cells therapy is effective in the treatment of facial rejuvenation.

Detailed Description
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This study will be a prospective study of patients who undergo adipose-derived stem cells therapy for facial rejuvenation at the hospital of Xuzhou medical university. The therapy involves injection of patient's own adipose-derived stem cells, which are separated from vacuumed fat obtained through liposuction of abdomen, hip, thigh and so on. It was confirmed the adipose-derived stem cells can be induced differentiation into fat cells, osteoblasts, chondrocytes, muscle cells, endothelial cells and so on under the corresponding condition in the current literature. The therapy has evolved as a less invasive technique for facial rejuvenation compared to more traditional techniques，such as fat cells injection, sodium hyaluronate injection. Through the use of pre and post treatment photos, three-dimensional skin CT, in addition to the therapeutic evaluation, patient satisfaction questionnaire and a clinician assessment, it is our hope that the investigators will confirm the rejuvenating capabilities of adipose-derived stem cells therapy.

Official Title
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The Clinical Application of Adipose-Derived Stem Cells on Facial Rejuvenation

Conditions
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Facies

Intervention / Treatment
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* Biological: Adipose-derived stem cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females Ages18-60 Patients of all racial and ethnic origins Patients of all undergoing facial rejuvenation Exclusion Criteria: Ages under 18, and above 60 Female patients in pregnancy or menstrual period Patients undergoing facial rejuvenation using other methods including botox injections, chemical peels, face lifts and others Patients using blood thinners, aspirin and hormone, that cannot be stopped Patients suffering with severe organic disease, such as coronary heart disease, hypertension, diabetes, lung dysfunction and so on Patients suffering with mental disease, and acute or chronic infectious diseases

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Stem cells separation<br>Stem cells separation: The adipose-derived stem cells are separated from vacuumed fat obtained through liposuction of abdomen, hip, thigh and so on. It was confirmed the adipose-derived stem cells can be induced differentiation into fat cells under the special condition in the current literature.Stem cells are used to treat wrinkles and facial rejuvenation. | Biological: Adipose-derived stem cells<br>* The adipose-derived stem cells therapy involve injection of patient's own adipose-derived stem cells. Local anesthetic will be applied to the face prior to the injection. For adipose-derived stem cells preparation, proper volume of fat cells will be collected from each patient just before each procedure. The stem cells will be injected into each standardized injection point in a superficial manner. The injections points are along the inferior border of cheek and mid-cheek and temple, where will be followed by 10-15 minutes of icing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The therapeutic evaluation of adipose-derived stem cells or fat cells solely on facial rejuvenation | With the therapeutic evaluation of adipose-derived stem cells and fat cells solely on facial rejuvenation separately, which can reduce wrinkle and augment collagen of face skin. In order to assess the therapeutic effect, the investigators take face photos/make three-dimensional skin CT of face to evaluate the wrinkle and collagen before the therapy. Then take photos of face/ make three-dimensional skin CT of face to evaluate the wrinkle and collagen/ take patient satisfaction questionnaire and clinician assessment in 1 Months post-surgery. Take photos of face/ make three-dimensional skin CT of face/ take patient satisfaction questionnaire and clinician assessment in 3 Months post-surgery. Then take photos of face/ make three-dimensional skin CT of face to evaluate the wrinkle and collagen/ take patient satisfaction questionnaire and clinician assessment in 6 Months post-surgery. The investigators will summarize the therapeutic effect of facial rejuvenation based on the data. | 1,3 and 6 Months Post-Surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The therapeutic evaluation of adipose-derived stem cells combined with fat cells on facial rejuvenation | With the therapeutic evaluation of adipose-derived stem cells combined with fat cells on facial rejuvenation.The investigators take photos of face before the therapy and in 1, 3 and 6 Months Post-Surgery, take three-dimensional skin CT of face to evaluate the wrinkle and collagen and so on at the time points of pre-surgery and in 1, 3 and 6 Months post-surgery. In addition to the therapeutic evaluation, take patient satisfaction questionnaire and clinician assessment in 1, 3 and 6 Months post-surgery. The multiple measurements will be aggregated to arrive at facial rejuvenation. Compare the secondary outcome with primary outcome, then it can summarize the best method of facial rejuvenation. | 1,3 and 6 Months Post-Surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Facial Rejuvenation, Adipose-Derived Stem Cells