Safety Study of Filler Agent Composed of Umbilical Cord Mesenchymal Stem Cells and Hyaluronic Acid
1 other identifier
interventional
30
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2016
CompletedFirst Posted
Study publicly available on registry
March 4, 2016
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedMarch 4, 2016
February 1, 2016
2 years
February 4, 2016
March 3, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of patients with non-serious and serious adverse events
Change from baseline up to week 12 after injection.
Secondary Outcomes (2)
Wrinkle Severity Rating Scale (WSRS) Evaluation
Change from baseline at week 2, 6 and 12.
Global Aesthetic Improvement Scale (GAIS) Evaluation
Change from baseline at week 2, 6 and 12.
Study Arms (2)
UCMSCs-HA
EXPERIMENTALMultipoint of Transdermal injection into the wrinkles. Injectable filler agent composed of umbilical cord mesenchymal stem cells (UCMSCs) and hyaluronic acid (HA).
Control
ACTIVE COMPARATORProcedure: Transdermal injection of hyaluronic acid only.
Interventions
Eligibility Criteria
You may qualify if:
- Male or female over 18 years;
- Have ability to understand and comply with the study requirements, and provide the written informed consent prior to any procedures ;
- 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.
You may not qualify if:
- Patients unable to undergo surgery liposuction with Klein technique as those with severe cardiovascular disease, severe coagulation disorders including thrombophilia and pregnancy;
- Have history or active dermal diseases, inflammation, or any related disease;
- Had invasive aesthetic treatments or surgeries history 6 months before the treatments;
- Had physical or chemical aesthetic treatments 1 months before the study starts;
- Have a known history of allergic reactions like hypersensitivity to hyaluronic acid;
- Patients with limited understanding of the procedure or have poor compliance with the study or follow-up schedule;
- Pregnant or lactating;
- Use of drugs;
- Patients with preoperative results considered inadequate.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2016
First Posted
March 4, 2016
Study Start
December 1, 2016
Primary Completion
December 1, 2018
Last Updated
March 4, 2016
Record last verified: 2016-02