Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 4, 2016
First Posted Date  ICMJE March 4, 2016
Last Update Posted Date March 4, 2016
Study Start Date  ICMJE December 2016
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2016)
Proportion of patients with non-serious and serious adverse events [ Time Frame: Change from baseline up to week 12 after injection. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2016)
  • 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.
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of Filler Agent Composed of Umbilical Cord Mesenchymal Stem Cells and Hyaluronic Acid
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Senescence Wrinkles, Acne, Pitting Scar
Intervention  ICMJE
  • Biological: umbilical cord mesenchymal stem cells and hyaluronic acid
  • Drug: hyaluronic acid
Study Arms  ICMJE
  • 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).
    Intervention: Biological: umbilical cord mesenchymal stem cells and hyaluronic acid
  • Active Comparator: Control
    Procedure: Transdermal injection of hyaluronic acid only.
    Intervention: Drug: hyaluronic acid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 3, 2016)
30
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02698813
Other Study ID Numbers  ICMJE UCMSC-HA-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party South China Research Center for Stem Cell and Regenerative Medicine
Study Sponsor  ICMJE South China Research Center for Stem Cell and Regenerative Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account South China Research Center for Stem Cell and Regenerative Medicine
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP