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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05813379
Other study ID # Islamic Azad University
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date February 1, 2022
Est. completion date August 30, 2023

Study information

Verified date April 2023
Source Isfahan University of Medical Sciences
Contact Leila Dehghani, Dr
Phone +983136201250
Email l_dehghani2002@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date August 30, 2023
Est. primary completion date July 29, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 35 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Combination Product:
exosime injection
Treatment- exosome injection

Locations

Country Name City State
Iran, Islamic Republic of Isfahan University of Medical Sciences Isfahan

Sponsors (1)

Lead Sponsor Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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