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Exosome Effect on Prevention of Hairloss

Sponsor
Isfahan University of Medical Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT05658094
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
14.9
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Many people suffer from alopecia, which is caused by hereditary factors, emotional stress, and psychiatric disorders. There are devastating physical and psychological consequences as a result. Exosomes are isolated from donated human amniotic mesenchymal stem cells and purified using specific processing. Exosomes are unique in that they are derived from stem cells and contain a wide range of growth factors. The latest generation of natural products for treating hair loss is exosomes.

Condition or Disease Intervention/Treatment Phase
  • Device: Exosome
 N/A

Detailed Description

Exosomes contain a variety of growth factors that are derived from stem cells. As they are so small, they can be hidden in the bloodstream and carry different types of proteins.

The Wnt-β-catenin pathway is thought to play a major role in the pathogenesis of hair loss. The only FDA-approved medications for the treatment of hair loss are minoxidil (a vasodilator) and finasteride (a selective inhibitor of 5α reductase type II and III isoforms). However, these drugs have not been very perfect. Both have been associated with limited efficacy, duration of effect, and several significant side effects. Regenerative medicine using cell products is looking for a way to heal faster and less cost. Present research focus on Exosome efficacy on hairloss.

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:
Placental Mesenchymal Stem Cells-derived Exosome for Hairloss
Actual Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
May 29, 2023
Anticipated Study Completion Date :
Oct 29, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Exosome

Exosome (100e10 particle) injections with an interval of 14 days during two months.

Device: Exosome
Each patients will receive 4 injection with an interval of 14 days during two months
Other Names:
  • Extracellular Vesicle

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in mean total hair density (hair/cm2) [0 months]

      Measurement of hair density by phototrichogram: change in mean total hair density (hair/cm^2)

    2. Change in mean total hair density (hair/cm2) [3 months]

      Measurement of hair density by phototrichogram: change in mean total hair density (hair/cm^2)

    3. Change in mean total hair density (hair/cm2) [6 months]

      Measurement of hair density by phototrichogram: change in mean total hair density (hair/cm^2)

    4. visual assessment before and after [6 months]

      Visual Assessment using the clinical picture by a general physician

    Secondary Outcome Measures

    1. Change in mean Telogen and Anagen hair density [0, months]

      Measurement of telogen and Anagen hair density before and after trial

    2. Change in mean Telogen and Anagen hair density [3 months]

      Measurement of telogen and Anagen hair density before and after trial

    3. Change in mean Telogen and Anagen hair density [6 months]

      Measurement of telogen and Anagen hair density before and after trial

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    subjects able to read the documents and have medical coverage

    Subjects have a "hair loss grade" as below criteria:

    1. BASP grade: Basic type (M2 to M3, or C2 to C3, or U1 to U3) or Specific type (V1 to V3, or F1 to F3)

    2. For female: Ludwig grade: Ⅰ to Ⅱ

    3. For male: Norwood-Hamilton grade: III to IV

    4. Hair density by phototrichogram: 60 to 190 hair/cm2

    5. Telogen hair ≥ 5% Subject agreeing not to apply any topical treatment Subject agreeing to use a neutral shampoo

    Exclusion Criteria:

    1. Sick subject in situation of emergency.

    2. Subjects who have hereditary history of hairloss

    3. Pregnant Females

    4. Subject using topic cosmetic treatment or oral nutritional supplement likely to interfere on hair loss parameters during the last 3 months prior to the start of the study (screening)

    5. Subjects who have a medical treatment for alopecia or having stopped it from than 3 months

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Leila Dehghani Isfahan Iran, Islamic Republic of 8179997781

    Sponsors and Collaborators

    • Isfahan University of Medical Sciences

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Leila Dehghani, Dr Leila Dehghani, Isfahan University of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT05658094
    Other Study ID Numbers:
    • Isfahan Med Uni
    First Posted:
    Dec 20, 2022
    Last Update Posted:
    Dec 20, 2022
    Last Verified:
    Dec 1, 2022
    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, Dr Leila Dehghani, Isfahan University of Medical Sciences
    Exosome
    Additional relevant MeSH terms:
    Alopecia

    Study Results

    No Results Posted as of Dec 20, 2022