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

NCT ID: NCT02698813

Last Updated: 2016-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

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.

Detailed Description

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Conditions

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Senescence Wrinkles, Acne, Pitting Scar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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UCMSCs-HA

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

Group Type EXPERIMENTAL

umbilical cord mesenchymal stem cells and hyaluronic acid

Intervention Type BIOLOGICAL

Control

Procedure: Transdermal injection of hyaluronic acid only.

Group Type ACTIVE_COMPARATOR

hyaluronic acid

Intervention Type DRUG

Interventions

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umbilical cord mesenchymal stem cells and hyaluronic acid

Intervention Type BIOLOGICAL

hyaluronic acid

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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South China Research Center for Stem Cell and Regenerative Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Xuetao Pei, M.D., Ph.D

Role: CONTACT

8610-68164807

Fang Fang, Ph.D

Role: CONTACT

8620-89199011

Other Identifiers

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UCMSC-HA-1

Identifier Type: -

Identifier Source: org_study_id

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