NCT06217627

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2021

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 22, 2024

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

1.9 years

First QC Date

January 10, 2024

Last Update Submit

February 2, 2024

Conditions

Skin Rejuvenation

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Histological examination

    skin biopsies were performed at two moments: before treatment and after 12 months.

Study Arms (2)

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.

Biological: secretome

UC-explants secretome

EXPERIMENTAL

30 participants received UC-explants secretome in the left and right hands

Biological: secretome

Interventions

secretomeBIOLOGICAL

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.

UC-explants secretomeUmbilical cord (UC)- mesenchymal stem cells (MSCs) secretome

Eligibility Criteria

Age25 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsDue 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.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • patients with active skin diseases (e.g. atopic dermatitis, psoriasis, rosacea, seborrheic dermatitis)
  • patients using other anti-aging treatments within 1 month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

COR clinic of Regenerative Medicine

Beirut, 0000, Lebanon

Location

MeSH Terms

Interventions

Secretome

Intervention Hierarchy (Ancestors)

MetabolomeMetabolism

Study Officials

  • Nada Alaaeddine, PhD

    COR clinic of Regenerative Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dean of health Sciences at MUBS

Study Record Dates

First Submitted

January 10, 2024

First Posted

January 22, 2024

Study Start

March 5, 2021

Primary Completion

January 25, 2023

Study Completion

June 30, 2023

Last Updated

February 6, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

LE(1)