Exosome Effect on Prevention of Hairloss

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Placental Mesenchymal Stem Cells-derived Exosome for Hairloss

Conditions
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Hair Loss, Alopecia

Intervention / Treatment
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* Device: Exosome


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: subjects able to read the documents and have medical coverage Subjects have a hair loss grade as below criteria: 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) For female: Ludwig grade: Ⅰ to Ⅱ For male: Norwood-Hamilton grade: III to IV Hair density by phototrichogram: 60 to 190 hair/cm2 Telogen hair ≥ 5% Subject agreeing not to apply any topical treatment Subject agreeing to use a neutral shampoo Exclusion Criteria: Sick subject in situation of emergency. Subjects who have hereditary history of hairloss Pregnant Females 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) Subjects who have a medical treatment for alopecia or having stopped it from than 3 months

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exosome<br>Exosome (100e10 particle) injections with an interval of 14 days during two months. | Device: Exosome<br>* Each patients will receive 4 injection with an interval of 14 days during two months<br>* Other names: Extracellular Vesicle;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean total hair density (hair/cm2) | Measurement of hair density by phototrichogram: change in mean total hair density (hair/cm^2) | 0 months | 
| Change in mean total hair density (hair/cm2) | Measurement of hair density by phototrichogram: change in mean total hair density (hair/cm^2) | 3 months | 
| Change in mean total hair density (hair/cm2) | Measurement of hair density by phototrichogram: change in mean total hair density (hair/cm^2) | 6 months | 
| visual assessment before and after | Visual Assessment using the clinical picture by a general physician | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean Telogen and Anagen hair density | Measurement of telogen and Anagen hair density before and after trial | 0, months | 
| Change in mean Telogen and Anagen hair density | Measurement of telogen and Anagen hair density before and after trial | 3 months | 
| Change in mean Telogen and Anagen hair density | Measurement of telogen and Anagen hair density before and after trial | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exosome