Mesenchymal Stem Cells Derived Exosomes in Skin Rejuvenation

April 1, 2023 updated by: Leila Dehghani, Isfahan University of Medical Sciences

Application of Mesenchymal Stem Cells Derived Exosomes in Skin Rejuvenation

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: exosome 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
Combination product: exosime injection
Treatment- exosome injection

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isfahan University of Medical Sciences

Investigators

  • Principal Investigator: Leila Dehghani, university of medical sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Anticipated)

July 29, 2023

Study Completion (Anticipated)

August 30, 2023

Study Registration Dates

First Submitted

December 26, 2022

First Submitted That Met QC Criteria

April 1, 2023

First Posted (Actual)

April 14, 2023

Study Record Updates

Last Update Posted (Actual)

April 14, 2023

Last Update Submitted That Met QC Criteria

April 1, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Islamic Azad University

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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