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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Umbilical cord (UC)- mesenchymal stem cells (MSCs) secretome | Experimental | 19 participants received UC-MSCs secretome injections in the neck and different areas of the face including the forehead, cheeks, under eyes, chin, and nasolabial folds. |
|
| UC-explants secretome | Experimental | 30 participants received UC-explants secretome in the left and right hands |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| secretome | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) | 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) | digital photographs before injection and after 7 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Histological examination | The histological examination of skin biopsies evaluated the assessment of collagen, keratin, elastin, basement membrane of blood vessels, and fibroblast nuclei. | skin biopsies were performed at two moments: before treatment and after 12 months. |
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Inclusion Criteria:
Exclusion Criteria:
Due to the fact that women are more likely than men to keep track of their skin condition more regularly and to adhere to study procedures, women participants were chosen in this study to homogenize the data and prevent drop-outs.
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| Name | Affiliation | Role |
|---|---|---|
| Nada Alaaeddine, PhD | COR clinic of Regenerative Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| COR clinic of Regenerative Medicine | Beirut | 0000 | Lebanon |
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| ID | Term |
|---|---|
| D000089282 | Secretome |
| ID | Term |
|---|---|
| D055442 | Metabolome |
| D008660 | Metabolism |
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