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

Phase 1

• Conditions: Senescence Wrinkles, Acne, Pitting Scar
• Interventions: Biological: umbilical cord mesenchymal stem cells and hyaluronic acid; Drug: hyaluronic acid

• Registration Number: NCT02698813
• Lead Sponsor: South China Research Center for Stem Cell and Regenerative Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-02
• Study First Submitted: 2016-02-04
• Study First Submitted QC: 2016-03-03
• Last Update Submitted: 2016-03-03
• Study First Posted: 2016-03-04
• Last Update Posted: 2016-03-04
• Study Start: 2016-12
• Primary Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Male or female over 18 years;
2. Have ability to understand and comply with the study requirements, and provide the written informed consent prior to any procedures ;
3. 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

1. Patients unable to undergo surgery liposuction with Klein technique as those with severe cardiovascular disease, severe coagulation disorders including thrombophilia and pregnancy;
2. Have history or active dermal diseases, inflammation, or any related disease;
3. Had invasive aesthetic treatments or surgeries history 6 months before the treatments;
4. Had physical or chemical aesthetic treatments 1 months before the study starts;
5. Have a known history of allergic reactions like hypersensitivity to hyaluronic acid;
6. Patients with limited understanding of the procedure or have poor compliance with the study or follow-up schedule;
7. Pregnant or lactating;
8. Use of drugs;
9. Patients with preoperative results considered inadequate.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UCMSCs-HA	umbilical cord mesenchymal stem cells and hyaluronic acid	Multipoint of Transdermal injection into the wrinkles. Injectable filler agent composed of umbilical cord mesenchymal stem cells (UCMSCs) and hyaluronic acid (HA).
Control	hyaluronic acid	Procedure: Transdermal injection of hyaluronic acid only.

Primary Outcome Measures

Name	Time	Method
Proportion of patients with non-serious and serious adverse events	Change from baseline up to week 12 after injection.

Secondary Outcome Measures

Name	Time	Method
Global Aesthetic Improvement Scale (GAIS) Evaluation	Change from baseline at week 2, 6 and 12.	An improvement was judged by the outcome of the preoperative grade minus the postoperative grade in accordance with the Global Aesthetic Improvement Scale (GAIS).
Wrinkle Severity Rating Scale (WSRS) Evaluation	Change from baseline at week 2, 6 and 12.	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.