Skin Rejuvenation Using Stem Cell Secretome

Phase 1

Completed

• Conditions: Skin Rejuvenation
• Interventions: Biological: secretome

• Registration Number: NCT06217627
• Lead Sponsor: COR clinic of Regenerative Medicine

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.

Study Timeline

• Study Start: 2021-03-05
• Primary Completion: 2023-01-25
• Study Completion: 2023-06-30
• Study First Submitted: 2024-01-10
• Study First Submitted QC: 2024-01-19
• Study First Posted: 2024-01-22
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-02
• Last Update Posted: 2024-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 49

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Umbilical cord (UC)- mesenchymal stem cells (MSCs) secretome	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.
UC-explants secretome	secretome	30 participants received UC-explants secretome in the left and right hands

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

COR clinic of Regenerative Medicine; 🇱🇧 Beirut, Lebanon