Skin Rejuvenation Using Stem Cell Secretome

Skin Rejuvenation Clinical Trial

Official title:

The Potential of Umbilical Cord Stem Cell Secretions in Skin Rejuvenation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06217627
• Other study ID #: S2021-cor001
• Status: Completed
• Phase: Phase 1
• Start date: March 5, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: February 2024
• Source: COR clinic of Regenerative Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: June 30, 2023
• Est. primary completion date: January 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Skin Rejuvenation

Intervention

Biological:
• secretome
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.

Locations

Country	Name	City	State
Lebanon	COR clinic of Regenerative Medicine	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
COR clinic of Regenerative Medicine

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.
Primary	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.
Secondary	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.