Skin Rejuvenation Using Stem Cell Secretome

COR clinic of Regenerative Medicine

Status and phase: Completed; Phase 1

Conditions: Skin Rejuvenation

Treatments: Biological: secretome

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT06217627

S2021-cor001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: Female

Ages: 25+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

Umbilical cord (UC)- mesenchymal stem cells (MSCs) secretome

Experimental group

Description:

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.

Treatment:

Biological: secretome

UC-explants secretome

Experimental group

Description:

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

Treatment:

Biological: secretome