## Protocol Section
### Identification Module
**NCT ID:** NCT05813379

**Brief Title:** Mesenchymal Stem Cells Derived Exosomes in Skin Rejuvenation

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

#### Organization Study ID Info
**ID:** Islamic Azad University
#### Organization
**Class:** OTHER
**Full Name:** Isfahan University of Medical Sciences
### Status Module
#### Completion Date
**Date:** 2023-08-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-04-14

**Type:** ACTUAL

**Last Update Submit Date:** 2023-04-01

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2023-07-29

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-02-01

**Type:** ACTUAL

**Status Verified Date:** 2023-04

#### Study First Post Date
**Date:** 2023-04-14
**Type:** ACTUAL
**Study First Submit Date:** 2022-12-26
**Study First Submit QC Date:** 2023-04-01
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Isfahan University of Medical Sciences

#### Responsible Party

**Investigator Affiliation:** Isfahan University of Medical Sciences

**Investigator Full Name:** Leila Dehghani

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Anti Aging

**Keywords:**

- Anti aging

- Rejuvenation

- Repair

- Regeneration

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Phases:**

- PHASE1

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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

**Intervention Names:**

- Combination Product: exosime injection

**Label:** exosome injection

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- exosome injection

**Description:** Treatment- exosome injection

**Name:** exosime injection

**Type:** COMBINATION_PRODUCT

### Outcomes Module

#### Primary Outcomes

**Description:** In order to evaluate the treatment effect, to evaluate wrinkles and collagen before the treatment, take a photo/CT of the face

**Measure:** Proportion of re-epithelialization

**Time Frame:** 1 month

**Description:** In order to evaluate the treatment effect, to evaluate wrinkles and collagen before the treatment, take a photo/CT of the face

**Measure:** Proportion of re-epithelialization

**Time Frame:** 3 months

### Eligibility Module

**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

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 35 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** l_dehghani2002@yahoo.com

**Name:** Leila Dehghani, Dr

**Phone:** +983136201250

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Isfahan

**Contacts:**

***Contact 1:***

- **Email:** l_dehghani2002@yahoo.com

- **Name:** Leila Dehghani, PhD

- **Phone:** +983136202020

- **Phone Ext:** 2146

- **Role:** CONTACT

**Country:** Iran, Islamic Republic of

**Facility:** Isfahan University of Medical Sciences

**Status:** RECRUITING

**Zip:** 81745319

#### Overall Officials

**Official 1:**

**Affiliation:** university of medical sciences

**Name:** Leila Dehghani

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
