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

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ClinicalTrials.gov Identifier: NCT02698813
Recruitment Status : Unknown
Verified February 2016 by South China Research Center for Stem Cell and Regenerative Medicine.
Recruitment status was:  Not yet recruiting
First Posted : March 4, 2016
Last Update Posted : March 4, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Senescence Wrinkles, Acne, Pitting Scar Biological: umbilical cord mesenchymal stem cells and hyaluronic acid Drug: hyaluronic acid Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Study Start Date : December 2016
Estimated Primary Completion Date : December 2018

Resource links provided by the National Library of Medicine


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



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

Secondary Outcome Measures :
  1. 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.

  2. 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).



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02698813


Contacts
Contact: Xuetao Pei, M.D., Ph.D 8610-68164807 AMMS0906@163.com
Contact: Fang Fang, Ph.D 8620-89199011 fangfang@scrm.org.cn

Sponsors and Collaborators
South China Research Center for Stem Cell and Regenerative Medicine

Responsible Party: South China Research Center for Stem Cell and Regenerative Medicine
ClinicalTrials.gov Identifier: NCT02698813     History of Changes
Other Study ID Numbers: UCMSC-HA-1
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: March 4, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents