Safety Study of Filler Agent Composed of Umbilical Cord Mesenchymal Stem Cells and Hyaluronic Acid

Study Overview
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Brief Summary
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The overall goal of this study is to evaluate the safety and exploratory efficacy of the injectable filler agent composed of umbilical cord mesenchymal stem cells and hyaluronic acid for the improvement of wrinkles, acne, pitting scar and so on.

Conditions
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Senescence Wrinkles, Acne, Pitting Scar

Intervention / Treatment
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* Biological: umbilical cord mesenchymal stem cells and hyaluronic acid
* Drug: hyaluronic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female over 18 years; Have ability to understand and comply with the study requirements, and provide the written informed consent prior to any procedures ; Suitable for the medical history and physical examination like the following preoperative laboratory tests results: complete blood count, coagulation, biochemistry, electrocardiogram, hepatogram and β-human chorionic gonadotropin (hCG) for women of childbearing age. Exclusion Criteria: Patients unable to undergo surgery liposuction with Klein technique as those with severe cardiovascular disease, severe coagulation disorders including thrombophilia and pregnancy; Have history or active dermal diseases, inflammation, or any related disease; Had invasive aesthetic treatments or surgeries history 6 months before the treatments; Had physical or chemical aesthetic treatments 1 months before the study starts; Have a known history of allergic reactions like hypersensitivity to hyaluronic acid; Patients with limited understanding of the procedure or have poor compliance with the study or follow-up schedule; Pregnant or lactating; Use of drugs; Patients with preoperative results considered inadequate.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UCMSCs-HA<br>Multipoint of Transdermal injection into the wrinkles. Injectable filler agent composed of umbilical cord mesenchymal stem cells (UCMSCs) and hyaluronic acid (HA). | Biological: umbilical cord mesenchymal stem cells and hyaluronic acid<br> <br> |
| Active Comparator: Control<br>Procedure: Transdermal injection of hyaluronic acid only. | Drug: hyaluronic acid<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with non-serious and serious adverse events |  | Change from baseline up to week 12 after injection. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wrinkle Severity Rating Scale (WSRS) Evaluation | An improvement was judged by the outcome of the preoperative grade minus the postoperative grade in accordance with the Wrinkle Severity Rating Scale (WSRS).The severity was measured using the Wrinkle Severity Rating Scale (WSRS), where 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Extreme, which is an ordinal scale. | Change from baseline at week 2, 6 and 12. | 
| Global Aesthetic Improvement Scale (GAIS) Evaluation | An improvement was judged by the outcome of the preoperative grade minus the postoperative grade in accordance with the Global Aesthetic Improvement Scale (GAIS). | Change from baseline at week 2, 6 and 12. |