Skin Rejuvenation
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALsecretome
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.
Sponsors
COR clinic of Regenerative Medicine
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* women participants aged \> 25 years * any skin type according to the Glogau scale * Willing to be a research subject, sign a consent form, and commit to follow-up visits
Exclusion criteria
* patients with active skin diseases (e.g. atopic dermatitis, psoriasis, rosacea, seborrheic dermatitis) * patients using other anti-aging treatments within 1 month
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Selected growth factors assessment | 4 samples of secretome extracted from UC-explants with one week interval. 1 sample of secretome extracted from confluent UC-MSCs at passage 1 | 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. |
| Wrinkle severity in hands | digital photographs before injection and after 7 months. | wrinkle severity was assessed in the hands by the Hand Volume Rating Scale: grade 0 (absent) to grade 4 (severe) |
| Wrinkle severity in the face and neck | digital photographs before injection and after 7 months. | wrinkle severity was assessed by the Wrinkle Severity Rating Scale: grade 0 (no wrinkles) to grade 5 ((very deep wrinkle and redundant fold) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Histological examination | skin biopsies were performed at two moments: before treatment and after 12 months. | The histological examination of skin biopsies evaluated the assessment of collagen, keratin, elastin, basement membrane of blood vessels, and fibroblast nuclei. |
Countries
Lebanon
Outcome results
None listed