Mesenchymal Stem Cells Derived Exosomes in Skin Rejuvenation

NCT05813379 | Unknown Phase 1 DMC

• 1 other identifier: Islamic Azad University
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Anti Aging

Keywords

Anti aging; Rejuvenation; Repair; Regeneration

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

exosome injection

EXPERIMENTAL

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

Interventions

exosime injection COMBINATION_PRODUCT

Treatment- exosome injection

exosome injection

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Isfahan University of Medical Sciences: lead

Study Sites (1)

Isfahan University of Medical Sciences

Isfahan, 81745319, Iran

RECRUITING

Study Officials

• Leila Dehghani

  university of medical sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leila Dehghani, Dr

CONTACT

+983136201250; l_dehghani2002@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 26, 2022
• First Posted: April 14, 2023
• Study Start: February 1, 2022
• Primary Completion: July 29, 2023
• Study Completion: August 30, 2023
• Last Updated: April 14, 2023

Record last verified: 2023-04

Locations

IR (1)