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

Not Applicable

• Conditions: Facies
• Interventions: Biological: Adipose-derived stem cells

• Registration Number: NCT02923219
• Lead Sponsor: Xuzhou Medical University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-08-22
• Status Verified: 2016-10
• Study First Submitted QC: 2016-10-02
• Last Update Submitted: 2016-10-02
• Study First Posted: 2016-10-04
• Last Update Posted: 2016-10-04
• Study Start: 2017-01
• Primary Completion: 2020-01
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stem cells separation	Adipose-derived stem cells	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.

Primary Outcome Measures

Name	Time	Method
The therapeutic evaluation of adipose-derived stem cells or fat cells solely on facial rejuvenation	1,3 and 6 Months Post-Surgery	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.

Secondary Outcome Measures

Name	Time	Method
The therapeutic evaluation of adipose-derived stem cells combined with fat cells on facial rejuvenation	1,3 and 6 Months Post-Surgery	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.