Mesenchymal Stem Cells Derived Exosomes in Skin Rejuvenation

Phase 1

Recruiting

• Conditions: Anti Aging
• Interventions: Combination Product: exosime injection

• Registration Number: NCT05813379
• Lead Sponsor: Isfahan University of Medical Sciences

Brief Summary

Aging is a natural and complex process. The effect of environmental factors, genetics on the body eventually leads to damage in different ways. Exosomes are present in almost all body fluids, such as synovial fluid and blood. Exosomes and microvesicles are very efficient mediators of cell-to-cell communication by transferring their specific cargo to recipient cells; for example, exosomes are involved in the delivery of genetic materials, causing epigenetic modifications in the target cells .The applications of MSC-derived exosomes have more effect in cutaneous regeneration by collagen stimulation.The basic biology of exosomes indicates that MSC-exosomes may contain MSC-specific components to exert specific effects on recipient cells, which are somewhat equivalent to the regenerative effects of MSCs. This study aims to slow down the aging process of the skin by using exosome.

Detailed Description

Skin aging is a complex biological process that can be classified into extrinsic or intrinsic aging. Intrinsic aging is an intrinsic degradation process that is caused by a decrease in the proliferation capacity leading to cell senescence. Angiogenesis is essential in various physiological processes, including wound healing and skin tissue regeneration. Literature reviews show that exosomes derived from human umbilical cord blood mesenchymal stem cells can cause Collagen stimulation and reduction of oxidative stress, WNT/βcatenin pathway signaling in the initial stages of causes the regeneration of skin damage . This study aims to slow down the aging process of the skin by using exosome.

Study Timeline

• Study Start: 2022-02-01
• Study First Submitted: 2022-12-26
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-01
• Last Update Submitted: 2023-04-01
• Study First Posted: 2023-04-14
• Last Update Posted: 2023-04-14
• Primary Completion: 2023-07-29
• Study Completion: 2023-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• females
• Ages 35-65
• Patients of all racial and ethnic origins
• Patients of all undergoing facial rejuvenation

Exclusion Criteria

• Female patients in pregnancy or menstrual period
• Patients undergoing facial rejuvenation using other methods including Botox injections, chemical peels, face lifts and others
• Patients using blood thinners, aspirin and hormone, that cannot be stopped
• Patients suffering with severe organic disease, such as coronary heart disease, hypertension, diabetes, lung dysfunction and so on
• Patients suffering with mental disease, and acute or chronic infectious diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
exosome injection	exosime injection	The Exosome will be injected into each standardized injection point in a superficial manner. The injections points are along the inferior border of cheek and mid-cheek and temple, where will be followed by 10-15 minutes of icing

Primary Outcome Measures

Name	Time	Method
Proportion of re-epithelialization	3 months	In order to evaluate the treatment effect, to evaluate wrinkles and collagen before the treatment, take a photo/CT of the face

Trial Locations

Locations (1)

Isfahan University of Medical Sciences; 🇮🇷 Isfahan, Iran, Islamic Republic of