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

South China Research Center for Stem Cell and Regenerative Medicine0 sites30 target enrollmentDecember 2016

ConditionsSenescence Wrinkles, Acne, Pitting Scar

Interventionsumbilical cord mesenchymal stem cells and hyaluronic acid hyaluronic acid

Drugshyaluronic acid

Overview

Phase: Phase 1
Intervention: umbilical cord mesenchymal stem cells and hyaluronic acid
Conditions: Senescence Wrinkles, Acne, Pitting Scar
Sponsor: South China Research Center for Stem Cell and Regenerative Medicine
Enrollment: 30
Primary Endpoint: Proportion of patients with non-serious and serious adverse events
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2016

End Date

December 2018

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

South China Research Center for Stem Cell and Regenerative Medicine

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

UCMSCs-HA

Multipoint of Transdermal injection into the wrinkles. Injectable filler agent composed of umbilical cord mesenchymal stem cells (UCMSCs) and hyaluronic acid (HA).

Intervention: umbilical cord mesenchymal stem cells and hyaluronic acid

Control

Procedure: Transdermal injection of hyaluronic acid only.

Intervention: hyaluronic acid

Outcomes

Primary Outcomes

Proportion of patients with non-serious and serious adverse events

Time Frame: Change from baseline up to week 12 after injection.

Secondary Outcomes

Global Aesthetic Improvement Scale (GAIS) Evaluation(Change from baseline at week 2, 6 and 12.)
Wrinkle Severity Rating Scale (WSRS) Evaluation(Change from baseline at week 2, 6 and 12.)