Mesenchymal Stem Cells Derived Exosomes in Skin Rejuvenation

Study Overview
=================
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.

Official Title
-----------------
Application of Mesenchymal Stem Cells Derived Exosomes in Skin Rejuvenation

Conditions
-----------------
Anti Aging

Intervention / Treatment
-----------------
* Combination Product: exosime injection


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: exosome injection<br>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 | Combination Product: exosime injection<br>* Treatment- exosome injection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of re-epithelialization | In order to evaluate the treatment effect, to evaluate wrinkles and collagen before the treatment, take a photo/CT of the face | 1 month | 
| Proportion of re-epithelialization | In order to evaluate the treatment effect, to evaluate wrinkles and collagen before the treatment, take a photo/CT of the face | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anti aging, Rejuvenation, Repair, Regeneration