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Status unknownNCT05813379Updated Apr 14, 2023

Mesenchymal Stem Cells Derived Exosomes in Skin Rejuvenation

A Phase 1/2 interventional study of exosime injection in Anti Aging, sponsored by Isfahan University of Medical Sciences. Status unknown at 1 site in Iran, Islamic Republic of. Open to female participants aged 35 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-14.

Sponsored by Isfahan University of Medical Sciences · Phase 1/2, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Apr 2023), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Feb 2022, registered Dec 2022).
Phase
Phase 1/2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
35 Years to 65 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Anti Aging

Keywords

  • Anti aging
  • Rejuvenation
  • Repair
  • Regeneration
03

In context

Lead sponsor

Isfahan University of Medical Sciences is the lead sponsor of 145 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 65 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • 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

Interventions

  • Combination productexosime injection

    Treatment- exosome injection

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 month

  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

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
  • Isfahan University of Medical Sciences
    Isfahan, 81745319, Iran, Islamic Republic of
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05813379
Lead sponsor
Isfahan University of Medical Sciences
Responsible party
Leila Dehghani (Principal Investigator, Isfahan University of Medical Sciences) — Principal investigator
First posted
Apr 14, 2023
Start date
Feb 1, 2022
Primary completion
Jul 29, 2023 (estimated)
Completion
Aug 30, 2023 (estimated)
Last update
Apr 14, 2023

Study contacts

Leila Dehghani, Dr
Contact
l_dehghani2002@yahoo.com
+983136201250
Leila Dehghani
principal investigator · university of medical sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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