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

South China Research Center for Stem Cell and Regenerative Medicine

Status and phase: Unknown; Phase 1

Conditions: Senescence Wrinkles, Acne, Pitting Scar

Treatments: Biological: umbilical cord mesenchymal stem cells and hyaluronic acid; Drug: hyaluronic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT02698813

UCMSC-HA-1

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

UCMSCs-HA

Experimental group

Description:

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

Treatment:

Biological: umbilical cord mesenchymal stem cells and hyaluronic acid

Control

Active Comparator group

Description:

Procedure: Transdermal injection of hyaluronic acid only.

Treatment:

Drug: hyaluronic acid