Skin Rejuvenation Using Stem Cell Secretome

NCT ID: NCT06217627

Last Updated: 2024-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-05

Study Completion Date

2023-06-30

Brief Summary

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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

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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.

Conditions

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Skin Rejuvenation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

secretome

Intervention Type 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.

UC-explants secretome

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

Group Type EXPERIMENTAL

secretome

Intervention Type 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.

Interventions

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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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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COR clinic of Regenerative Medicine

NETWORK

Sponsor Role lead

Responsible Party

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Nada Alaaeddine

Dean of health Sciences at MUBS

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nada Alaaeddine, PhD

Role: PRINCIPAL_INVESTIGATOR

COR clinic of Regenerative Medicine

Locations

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COR clinic of Regenerative Medicine

Beirut, , Lebanon

Site Status

Countries

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Lebanon

Other Identifiers

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S2021-cor001

Identifier Type: -

Identifier Source: org_study_id

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