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
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||December 2018|
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
- Proportion of patients with non-serious and serious adverse events [ Time Frame: Change from baseline up to week 12 after injection. ]
- 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).
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
|Contact: Xuetao Pei, M.D., Ph.D||8610-68164807||AMMS0906@163.com|
|Contact: Fang Fang, Ph.Dfirstname.lastname@example.org|