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

March 3, 2016 updated by: South China Research Center for Stem Cell and Regenerative Medicine
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: UCMSCs-HA
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
Active Comparator: Control
Procedure: Transdermal injection of hyaluronic acid only.
Drug: hyaluronic acid

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wrinkle Severity Rating Scale (WSRS) Evaluation
Time Frame: 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.
Change from baseline at week 2, 6 and 12.
Global Aesthetic Improvement Scale (GAIS) Evaluation
Time Frame: 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).
Change from baseline at week 2, 6 and 12.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South China Research Center for Stem Cell and Regenerative Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

February 4, 2016

First Submitted That Met QC Criteria

March 3, 2016

First Posted (Estimate)

March 4, 2016

Study Record Updates

Last Update Posted (Estimate)

March 4, 2016

Last Update Submitted That Met QC Criteria

March 3, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCMSC-HA-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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