This clinical trial aims to investigate the effect of umbilical cord explants (UC)-explants and UC-mesenchymal stem cells (MSCs) secretome on skin rejuvenation, to provide future reference or standard in the application of cell free-based therapy in skin aging.
This trial is a pilot clinical trial evaluating the effect of the secretions of umbilical cord explants and mesenchymal stem cells on skin rejuvenation. Also the concentration of selected growth factors was assessed in the secretome derived from UC-explants and UC-MSCs. Healthy women participants, after their consent, received secretome injections in their hands, face, and neck. Outcomes were assessed on the Hand Volume Rating Scale, Wrinkle Severity Rating Scale, and through histologic examination of skin biopsy at two different times: before treatment and after 12 months. A digital camera was used to obtain photographs of hands, face, and Neck at each visit. These were assessed by a single-blinded dermatologist. SPSS software version 26 (64-bit) was used for all analyses. Participants provided written informed consent and were asked not to change their routine skin care habits during the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
49
The secretome is the secretions of MSCs or explants from umbilical cord tissues. It contains diverse trophic molecules including cytokines, chemokines, angiogenic factors, and growth factors.
COR clinic of Regenerative Medicine
Beirut, Lebanon
Selected growth factors assessment
assessment of the concentration (pg/ml) of selected growth factors (bFGF, HGF, TIMP-3, VEGF, andTGF-b) in the secretome derived from UC-explants and UC-MSCs using ELISA essays.
Time frame: 4 samples of secretome extracted from UC-explants with one week interval. 1 sample of secretome extracted from confluent UC-MSCs at passage 1
Wrinkle severity in hands
wrinkle severity was assessed in the hands by the Hand Volume Rating Scale: grade 0 (absent) to grade 4 (severe)
Time frame: digital photographs before injection and after 7 months.
Wrinkle severity in the face and neck
wrinkle severity was assessed by the Wrinkle Severity Rating Scale: grade 0 (no wrinkles) to grade 5 ((very deep wrinkle and redundant fold)
Time frame: digital photographs before injection and after 7 months.
Histological examination
The histological examination of skin biopsies evaluated the assessment of collagen, keratin, elastin, basement membrane of blood vessels, and fibroblast nuclei.
Time frame: skin biopsies were performed at two moments: before treatment and after 12 months.
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