Mesenchymal Stem Cells Derived Exosomes in Skin Rejuvenation

Sponsor
Isfahan University of Medical Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT05813379
Collaborator
(none)
20
1
1
18.9
1.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: exosime injection
Phase 1/Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Application of Mesenchymal Stem Cells Derived Exosomes in Skin Rejuvenation
Actual Study Start Date :
Feb 1, 2022
Anticipated Primary Completion Date :
Jul 29, 2023
Anticipated Study Completion Date :
Aug 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Proportion of re-epithelialization [1 month]

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

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Isfahan University of Medical Sciences Isfahan Iran, Islamic Republic of 81745319

Sponsors and Collaborators

  • Isfahan University of Medical Sciences

Investigators

  • Principal Investigator: Leila Dehghani, university of medical sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Leila Dehghani, Principal Investigator, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT05813379
Other Study ID Numbers:
  • Islamic Azad University
First Posted:
Apr 14, 2023
Last Update Posted:
Apr 14, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Leila Dehghani, Principal Investigator, Isfahan University of Medical Sciences

Study Results

No Results Posted as of Apr 14, 2023