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Completed

NCT Number: NCT06217627

Skin Rejuvenation Using Stem Cell Secretome

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.

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Key information

Conditions

Skin Rejuvenation

Age range

25 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

COR clinic of Regenerative Medicine

Beirut, 0000, Lebanon

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Selected growth factors assessment

    Time frame: 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.

  2. Wrinkle severity in hands

    Time frame: 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)

  3. Wrinkle severity in the face and neck

    Time frame: 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 outcomes

  1. Histological examination

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

COR clinic of Regenerative Medicine

Network

Registry information

Official study title

The Potential of Umbilical Cord Stem Cell Secretions in Skin Rejuvenation

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 22, 2024
Registry last updated
Feb 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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