Skin Rejuvenation Using Stem Cell Secretome

The Potential of Umbilical Cord Stem Cell Secretions in Skin Rejuvenation

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.

Study Overview

• Status: Completed
• Conditions: Skin Rejuvenation
• Intervention / Treatment: Biological: secretome

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.

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 1

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon, 0000
    • COR clinic of Regenerative Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UC-explants secretome; 30 participants received UC-explants secretome in the left and right hands	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.
Experimental: Umbilical cord (UC)- mesenchymal stem cells (MSCs) secretome; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: COR clinic of Regenerative Medicine
• Investigators: Principal Investigator: Nada Alaaeddine, PhD, COR clinic of Regenerative Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2021
• Primary Completion (Actual): January 25, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: January 10, 2024
• First Submitted That Met QC Criteria: January 19, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: S2021-cor001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No